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Call for Rare Diseases projects

Description: Auto Generated Title The NIHR BioResource for Translational Research is a national resource of more than 145,000 participants who are
Url: /ClinicalResearchinSouthampton/For-researchers/NIHR-BioResource/Call-for-Rare-Diseases-projects.aspx

Press release: Hospital staff and supporters to celebrate development of new cancer support centre

Description: Staff and supporters at Southampton's university hospitals will celebrate the development of a new £5 million support centre for cancer patients
Url: /AboutTheTrust/Newsandpublications/Latestnews/2019/February/Press-release-Hospital-staff-and-supporters-to-celebrate-development-of-new-cancer-support-centre.aspx

Caroline Grabau, adult senior research sister

Description: NIHR Southampton Clinical Research Facility Auto Generated Title Caroline provides nursing leadership and support to four adult nursing teams ensuring that
Url: /ClinicalResearchinSouthampton/Our-people/Clinical-research-facility-people/Caroline-Grabau-adult-senior-research-sister.aspx

Prof John Fleming, scientific lead for imaging group

Description: NIHR Southampton Biomedical Research Centre Auto Generated Title Prof Fleming is a clinical scientist working on the use of medical imaging to improve the diagnosis and treatment of patients with respiratory disease. Email: John.fleming@uhs.nhs.uk John has extensive experience in analysing images using computers, to improve their interpretation and hence their clinical usefulness. As scientific lead for the imaging group of the NIHR Southampton Biomedical Research Centre, he seeks to develop clinical applications of use of image analysis techniques in lung imaging, in collaboration with medical colleagues. Focussed on better respiratory care Prof Fleming's main research interest is in developing the use of medical imaging for the diagnosis and treatment of patients with respiratory disease. He is the scientific lead of the imaging group of the NIHR Southampton Biomedical Research Centre and a consultant to Air Liquide. National and international roles Prof Fleming is a reviewer or editorial board member for a number of scientific journals and sits on several national or international advisory panels. He recently took a leading role in developing international guidelines for imaging inhaled aerosol deposition, on behalf of the International Society of Aerosols in Medicine - you can find out more here . Extensive expertise He has worked in the field of imaging physics for over 40 years, with particular interest in nuclear medicine, which uses images of radioactive materials distributed in the body to measure the function of various body systems. This work has included developments in techniques for forming the images, and in the analysis and interpretation of the data. In particular, Prof Fleming has introduced new methods of analysing nuclear medicine images on computers and deriving clinically useful information from them. John has published around 140 research articles on these themes. In the UK he initiated an audit scheme for nuclear medicine software and produced guidelines for measurement of glomerular filtration rate. Career John obtained a BSc in physics and PhD in medical physics from the University of Southampton. He has worked in Southampton hospitals throughout his career, progressing to head of nuclear medicine physics and medical imaging. He was elected as fellow of the Institute of Physics and Engineering in Medicine in 1988 and appointed at the University as honorary senior lecturer in 1989, reader in 1996 and professor in 2000.
Url: /ClinicalResearchinSouthampton/Our-people/Respiratory-research-people/Prof-John-Fleming,-scientific-lead-for-imaging-group.aspx

Prof Tim Elliott, experimental oncology

Description: NIHR CRUK Experimental Cancer Medicine Centre Auto Generated Title Professor Elliott ’ s research looks at how the body prepares viruses and cancer cells for recognition (and eventual destruction) by the immune system. Email: T.j.elliott@soton.ac.uk This process is known as antigen processing, and is important for developing vaccines and therapies that involve modifying the immune response (immunotherapies). Cancer, respiratory and rheumatology research This research feeds into translational programmes in vaccine development at the Experimental Cancer Medicine Centre, NIHR Southampton Biomedical Research Centre and in rheumatology at Southampton. Markers of disease and rheumatic disease targets Professor Elliott ’ s research focus with Dr Edd James at the Cancer Sciences Unit has identified biomarkers (molecules associated with specific diseases) and a potential therapeutic target for autoinflammatory diseases, including ankylosing spondylitis. Leading vaccine research His studies benefit from combining approaches from the physical sciences, synthetic and computational chemistry, enabling him to model immune pathways to predict the outcome of responses to infection, cancer and vaccines. Professor Elliott was among a key group of immunologists in the 1980s who developed studies of how antigens are recognised by the immune system at the molecular level, work on which much recent vaccine development has been built. This work continues to fuel clinical research in Southampton, where discoveries in the areas of antigen discovery, immune 'T' cell control and immunodominance are impacting new cancer vaccine trials. Career Before his current appointment at the University of Southampton, Professor Elliott held a lectureship and then a professorship in immunology at Weatherall Institute for Molecular Medicine and Balliol College, University of Oxford. He has published more than 120 research papers, given over 100 research lectures, has sat on national and international scientific advisory boards (such as the Wellcome Trust and the Association of International Cancer Research) and serves on seven editorial boards. Professor Elliott has a first in Biochemistry from the University of Oxford, a PhD from the University of Southampton, and completed his postdoctoral training at the Massachussetts Institute of Technology.
Url: /ClinicalResearchinSouthampton/Our-people/Cancer-research-people/Prof-Tim-Elliott.aspx

BEACON protocol v8.0 07Mar2023 signed

Description: A randomised phase IIb trial of BE AC v izumab added to Temozolomide O ± Irin tecan for children with N refractory/relapsed euroblastoma Version 8.0 dated 07-Mar-2023 Dinutuximab beta amendment Coordinating Sponsor: Sponsor Protocol Number: CAS Code: EudraCT Number: ISRCTN Reference Number: ITCC Number: Roche Study Reference Number: Email: University of Birmingham RG_ 11-087 BN2008 2012-000072-42 40708286 032 MO28245 beacon@trials.bham.ac.uk This application is supported by the facilities funded through Birmingham Science City: Translational Medicine Clinical Research Infrastructure and Trials Platform, an Advantage West Midlands (AWM) funded project which forms part of the Science City University of Warwick and University of Birmingham Research Alliance. BEACON-Neuroblastoma Protocol_vn 8.0_vd 07Mar2023 Page1 of 157 BEACON-Neuroblastoma Trial Protocol AMENDMENTS The following amendments and/or administrative changes have been made to this protocol since the implementation of the first approved version Amendment Date of number amendment Protocol version number Type of amendment SA 1 29-Jan-2013 2.0 Substantial Amendment N/A 23-Apr-2013 2.0a Non-Substantial Amendment N/A 01-Jul-2013 2.0b Non-Substantial Amendment Summary of amendment Introduction of the recommendation of weekly monitoring of blood counts for all patients receiving irinotecan. Addition of planned vaccination with live vaccination to exclusion criteria and prohibited medications section. ITCC Number has been corrected. Roche Study Reference Number and ISRCTN Reference Number have been added. Contact details for Plasma & Tumour Angiogenesis-Related Biomarkers have been amended. Table numbers have been corrected. Addition of guidance for research bone marrow sampling in Schedule of Activities table and sections 7.4.2.2 and 7.5.2. Addition of paragraph to sections 7.2, 7.6.1 – 7.6.4 detailing arrangements for handling dose modifications for Irinotecan + Temozolomide for patients receiving Bevacizumab. Discontinuation rules for osteonecrosis of the jaw and eye disorders added to table 13 in section 7.6.4. Correction to table number references in section 7.6.3. Clarification made in section 13.4.1 concerning Planned Interim Analysis. SA 3 06-Oct-2014 4.0 Substantial Amendment Changes to the Trial Personnel section of the protocol to include the addition of contact details for Denmark and Ireland Lead Investigators. Amendments to reflect the changes in study sampling requirements to Trial Synopsis, Schedule of Activities table and sections 1.2.6, 2.1, 2.2, 5.1, 5.2, 7.3, 7.4.2 and 7.5. Amendment to exclusion criteria in Trial Synopsis and section 4.2. Changes to the Schedule of Activities table to include the addition of an echocardiogram to be performed at screening and Tanner staging at screening and yearly in follow up. Changes to the time line for measuring renal function prior to commencing treatment in the Trial Synopsis, Schedule of Activities and section 4.1. BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 3 of 157 BEACON-Neuroblastoma Trial SA 4 06-Oct-2014 4.0 SA 5 30-Jul-2015 5.0 Substantial Amendment Substantial Amendment Protocol Option to fax emergency randomisation removed. Telephone only in section 6.2 Changes to guidelines in section 7.2 for dose calculation in patients whose weight exceeds the 98th centile for age. Removal of enhanced data collection for Adverse Events of Special Interest (AESI) in section 7.6 and 9.1.2. Addition of option to extend treatment delay with agreement from Sponsor in Section 7.6.1 Addition of necrotising fasciitis as an adverse event requiring bevacizumab discontinuation in section 7.6.4. Changes to section 7.10 concerning the documenting of concomitant medications in patient medical notes and administration of bisphosphonates. Changes to section 9.1 regarding reporting of laboratory adverse events. Clarification on the arrangements for Follow Up Form completion for patients who do not require further follow up visits in section 11. Changes to bevacizumab and irinotecan preparation and dispensing guidelines in sections 8.2.4 and 8.3.3. Clarification on fasting arrangements prior to temozolomide administration added to section 8.4.3. Changes to events that should be reported on an Expected SAR Form in section 9.1.3.1. Clarification on SAEs that should be reported to F.Hoffman-La Roche Ltd in section 9.2.6 Addition of Trial Management Group meeting frequency in section 14.4. Changes to the wording of irinotecan randomisation in section 13.4.2. Addition of guidelines for dose reduction and discontinuation of temozolomide for liver toxicity in tables 8, 9, 10 & 11. Reference to the National Coordinating Centres has been changed to National CoSponsor throughout. Reference to Sponsor has been changed to Coordinating Sponsor. Change of Chief Investigator to Professor Pamela Kearns. Change of Principal Investigator at Royal Marsden Hospital to Dr Sucheta Vaidya. No changes made to the Protocol version. Chief Investigator and UK Lead Investigator changed to Dr Lucas Moreno Switzerland details added Schedule of events table amended for End Of Treatment clarity BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 4 of 157 BEACON-Neuroblastoma Trial N/A 23-Sep-2015 5.0a SA 6 16-Jan-2019 6.0a Protocol Topotecan added to the study as a new trial question and 2 new randomisation arms. The following sections are amended accordingly: Synopsis (Primary Objectives, sample size, Trial Duration, Trial therapy) Section 1 Background and rationale (Trial rationale) Section 3 Trial design (Randomisation) Section7.1 and 7.2 Treatment details Section7.6.1 Dose modifications Table 6 amended, Tables 11 and 12 added Section 8.4 Pharmaceutical Information Section 13 Statistical considerations The following changes were made to the Eligibility: Inclusion criteria – further details regarding birth control Exclusion criteria – Defined wash out period following prior IMP according to IMP half-life or 14 days. Lifestyle guidelines - further details regarding birth control Section 7.6 Dose modifications Figure 1 – reference to “chemo” changed to Temozolomide/Irinotecan/Topotecan” for clarity Section 8.2.4 Reference to “chemo” removed for clarity Section 7.6.4 AEs requiring Bevacizumab discontinuation – additional AEs added following Bevacizumab IB v22 Addendum Additional mRNA and exploratory sampling. Non-Substantial Amendment Substantial amendment The requirement for confirmatory scans was removed from the Schedule of Activities and Response assessment section 7.4.3. Lead Investigator for France amended to Dr Marion Gambart Minor wording corrections and clarifications Schedule of events table corrected Introduction of two new treatment arms (dinutuximab beta) for additional 64 patients Addition of eligibility criteria, schedule of events, treatment details, duration, cross over and dose modification details for new dinutuximab beta arms Adaptation of objectives, trial design, supporting treatment, pharmaceutical information and statistical consideration sections with new, relevant information. BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 5 of 157 BEACON-Neuroblastoma Trial N/A 11-Apr-2019 6.0b SA 7 07-Feb-2020 7.0 SA 22 07-Mar-2023 8.0 Protocol Non-Substantial Amendment Substantial Amendment Substantial Amendment Minor wording corrections and clarifications Version amended from 6.0 to 6.0a to add. Additional rationale to update typographical errors.) Trial Synopsis: Clarification of recruitment targets Clarification of Section 10 title: “Dinutuximab beta and topotecan randomisations” Clarification that not all biological studies will be open at any one time (Section 10.2 and 15.5) Minor wording corrections and clarifications Urgent Safety Measure – implemented on 28th January 2020 Closure of Temozolomide (T) and Dinutuximab beta and Temozolomide (dBT) arms with immediate effect. Section 1.1 Background Section 1.2.3 Benefit Risk assessment Section 3.1 Randomisation Section 10 Headings changed Section 10.3 Trial therapy Update of contact details Change of definition of End of Trial (Section 21). Protocol previously defined two stages of end of trial (6 months after last patient completes treatment and 12 months after last data capture after 5 years follow up). This has been combined into one End of Trial definition: 6 months after last patient last visit (i.e. after 5 years follow up) Also addition of option to email SAE form (Section 18.2.1.2) BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 6 of 157 BEACON-Neuroblastoma Trial Protocol TRIAL PERSONNEL Chief Investigator: Co-Investigators: Exploratory Biomarkers Dr Lucas Moreno Dr. Lucas Moreno, MD, PhD Director Paediatric Oncology & Haematology Division Vall d’Hebron Barcelona Hospital Campus Passeig de la Vall d’Hebron, 119-129, 08035, Barcelona, Spain  +34 93 489 3000  +34 93 489 4060  lucas.moreno@vhebron.net Professor Keith Wheatley Professor of Clinical Trials Cancer Research UK Clinical Trials Unit (CRCTU) Institute of Cancer and Genomic Sciences College of Medical and Dental Sciences University of Birmingham Birmingham, UK B15 2TT  +44 (0)121 415 9119  k.wheatley@bham.ac.uk Dr Juliet Gray Associate Professor and Consultant in Paediatric Oncology Southampton Children’s Hospital Tremona Road Southampton SO16 6YD  +44 (0) 790 1507929  juliet.gray@uhs.nhs.uk Dr Gudrun Schleiermacher Senior Scientist Institute Curie 26 rue d'Ulm 75248 Paris cedex 05 France  +33 (0)1 56 24 45 50  +33 (0)1 56 24 66 30  gudrun.schleiermacher@curie.net Professor Louis Chesler Paediatric Tumour Biology Team Institute of Cancer Research and Royal Marsden Hospital (University of London), Downs Road, Sutton Surrey, UK SM2 5PT  +44 (0) 208 722 4035 BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 7 of 157 BEACON-Neuroblastoma Trial Protocol  louis.chesler@icr.ac.uk Functional Imaging Study: Professor Andrew Peet Institute of Child Health University of Birmingham Whittall Street Birmingham, UK B4 6NH  +44 (0) 121 333 8234  +44 (0) 121 333 8241  a.peet@bham.ac.uk Dr Dow-Mu Koh Consultant Radiologist in Functional Imaging Royal Marsden Hospital Downs Road, Sutton, Surrey, UK SM2 5PT  +44 (0) 208 6613857  dow-mu.koh@icr.ac.uk Professor Martin Leach Co-Director, Cancer Research UK and EPSRC Centre for Cancer Imaging, Director, NIHR Clinical Research Facility Deputy Head, Division of Radiotherapy and Imaging Institute of Cancer Research and Royal Marsden Hospital (University of London), Downs Road, Sutton Surrey, UK SM2 5PT  +44 (0 208 661 3338  Martin.Leach@icr.ac.uk Molecular Monitoring mRNA Study: Professor Sue Burchill Leeds Institute of Cancer & Pathology St. James University Hospital Beckett Street Leeds, UK LS9 7TF  +44 (0) 113 206 5873  +44 (0) 113 242 9886  S.A.Burchill@leeds.ac.uk Professor Walter Gregory Clinical Trials Research Unit (CTRU) University of Leeds Clinical Trials Research House 71-75 Clarendon Road Leeds LS2 9PH  +44 (0) 113 343 1489  +44 (0) 113 343 1471 BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 8 of 157 BEACON-Neuroblastoma Trial Protocol Trial Statistician: Trial Coordinator & Trial Office: Randomisation Service: SAE Reporting:  W.M.Gregory@leeds.ac.uk Miss Grace Holt Cancer Research UK Clinical Trials Unit (CRCTU) Institute of Cancer and Genomic Sciences College of Medical and Dental Sciences University of Birmingham Birmingham, UK B15 2TT  +44 (0)121 414 8328  +44 (0)121 414 3700  G.C.Holt@bham.ac.uk Miss Punam Mistry Children’s Cancer Trials Team Cancer Research UK Clinical Trials Unit (CRCTU) Institute of Cancer and Genomic Sciences College of Medical and Dental Sciences University of Birmingham Birmingham, UK B15 2TT  +44 (0)121 414 3788  +44 (0)121 414 9520  beacon@trials.bham.ac.uk Provided by the CRCTU at the University of Birmingham Randomisation should be performed by sites online at: https://www.cancertrials.bham.ac.uk/BEACONLive In case of any problems with online randomisation, randomisation can be performed over the phone by the CRCTU on: 0800 371 969 or +44 (0)121 414 3366 SAEs should be faxed to the BEACON-Neuroblastoma Trial Office, CRCTU, University of Birmingham, UK  + 44 (0)121 414 9520 or +44 (0)121 414 3700 National Coordinating Investigators: Austria – Lead Investigator: Prof Dr Ruth Ladenstein St. Anna Children’s Hospital and CCRI /Studies and Statistics Department for Integrated Research and Projects (S²IRP) Kinderspitalgasse 6, Zimmermannplatz 10 A-1090 Vienna Austria +43-1-40470-4750  +43-1- 40470- 7430  ruth.ladenstein@ccri.at BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 9 of 157 BEACON-Neuroblastoma Trial Belgium Lead Investigator: Prof Genevieve Laureys Ghent University Hospital 9000 Ghent De Pinterlaan 185 Belgium  +32 93 32 34 48  genevieve.laureys@uzgent.be Denmark – Lead Investigator: Dr Karsten Nysom Dept. of Paediatrics & Adolescent Medicine Rigshospitalet Blegdamsvej 9 DK2100 Copenhagen Denmark  +45 35 45 08 09  +45 35 45 50 55  Karsten.nysom@regionh.dk France – Lead Investigator: Dr Marion Gambart Unité d'Hémato-Oncologie Hôpital des Enfants 330, avenue de Grande Bretagne TSA 70034 31059 Toulouse Cedex France  +33 (0)5 34 55 86 11  +33 (0)5 34 55 86 12  gambart.m@chu-toulouse.fr Germany - Lead Investigator: Dr. Simone Hettmer Zentrum für Kinder- und Jugendmedizin UNIVERSITÄTSKLINIKUM FREIBURG Mathildenstr. 1, 79106 Freiburg Germany  +49 761 270-43000  +49 761 270-45180  simone.hettmer@uniklinik-freiburg.de Ireland – Lead Investigator: Dr Cormac Owens Our Lady’s Children’s Hospital Crumlin Road, Crumlin Dublin 12 Ireland  +35314096659  +35313453041  Cormac.owens@olchc.ie Protocol BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 10 of 157 BEACON-Neuroblastoma Trial Protocol Italy – Lead Investigator: Dr. Aurora Castellano U.O.Oncoematologia Ospedale Pediatrico Bambino Gesù Pzza S. Onofrio 4 00165 Roma Italy +39 06 68592957-2678  +39 06 68592826  aurora.castellano@opbg.net Netherlands – Lead Investigator: Dr. C Michel Zwaan Erasmus Medical Center Sophia’s Children's Hospital Dr. Molewaterplein 60 3015 GJ Rotterdam +31 (0) 10 703 6691  +31(0) 10 703 6681  c.m.zwaan@erasmusmc.nl Spain – Lead Investigator: Dr. Victoria Castel Instituto de Investigación Sanitaria Unidad de Oncología Pediátrica Hospital Universitario La Fe Bulevar Sur, S/N 46026 Valencia Spain +34 963862758 Ext 50040  +34 963494416  castel_vic@gva.es Switzerland – Lead Investigator: Dr. Nicolas Gerber University Children’s Hospital, Steinwiesstrasse 75, CH-8032 Zurich, Switzerland +41 44 266 31 17  +41 44 266 34 61  Nicolas.gerber@kispi.uzh.ch UK – Lead Investigator: Dr Lucas Moreno Honorary Research Fellow University of Birmingham Birmingham, UK B15 2TT  +44 (0)121 414 3788  +44 (0)121 414 9520  lucas.moreno@vhebron.net, lmorenom@ext.cnio.es BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 11 of 157 BEACON-Neuroblastoma Trial Protocol TRIAL SYNOPSIS Title A randomised phase IIb trial of bevacizumab added to temozolomide ± irinotecan for children with refractory/relapsed neuroblastoma – BEACON-Neuroblastoma Trial Trial Design A phase II, randomised, open label, international multicentre 3x2 factorial trial. The dinutuximab beta amendment did utilise a 2x2 factorial design it will now be a simple two-way randomisation. Objectives Primary: - To test whether bevacizumab added to a backbone chemotherapy regimen (temozolomide, irinotecan + temozolomide or temozolomide + topotecan) demonstrates activity in children with relapsed or refractory neuroblastoma - To test whether the addition of irinotecan to temozolomide increases the activity of chemotherapy in children with relapsed or refractory neuroblastoma - To test whether the addition of topotecan to temozolomide increases the activity of chemotherapy in children with relapsed or refractory neuroblastoma (“topotecan randomisation”) - To test whether dinutuximab beta added to a backbone chemotherapy regimen (temozolomide or temozolomide + topotecan) demonstrates activity in children with relapsed or refractory neuroblastoma (“dinutuximab beta randomisation”) Secondary: - To evaluate the safety of the regimens Tertiary: - To undertake preliminary evaluation of the changes in magnetic resonance imaging (MRI) derived functional imaging biomarkers of angiogenesis - To undertake preliminary evaluation of the role of circulating mRNA levels for tyrosine hydroxylase (TH), paired-like homeobox 2b (PHOX2B) and doublecortin (DCX) as prognostic/predictive biomarkers in this refractory/relapsed setting - To undertake a preliminary evaluation of the role of tumour molecular profiles in blood and archival tumour tissue profiles as prognostic and predictive biomarkers - To undertake a preliminary evaluation of biomarkers of response to anti-GD2 therapy (Fc/KIR polymorphisms, Antibody Dependant Cell-Mediated Cytotoxicity (ADCC) and Anti-Drug Antibodies (ADAs) and of dinutuximab beta pharmacokinetics (PK) Outcome Measures Primary Endpoint: - Best response (Complete Response [CR] or Partial Response [PR]) [1] at any time during the first 6 cycles of trial treatment - For the bevacizumab part 2 only: Progression-free survival (PFS) Secondary Endpoints: - Safety of the regimens: Incidence and severity of Adverse Events (AE)s - PFS - Overall survival (OS) - Event-free survival (EFS) BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 12 of 157 BEACON-Neuroblastoma Trial Protocol Exploratory/Tertiary Endpoints: - Changes in (MRI) derived functional imaging biomarkers of angiogenesis measured by quantitative dynamic contrast enhanced (DCE) MRI: primary biomarkers will be the transfer constant Ktrans [min-1] and initial area under the gadolinium uptake curve from 0 to 60 seconds (IAUGC60, mM Gd min) and secondary biomarkers will be tumour apparent diffusion coefficient (ADC, 10-6 cm2 s-1), native T1 and T2 relaxation times (ms) and transverse relaxation rate R2* - Changes in circulating mRNA levels for TH, PHOX2B and DCX in bone marrow and blood samples - Pilot descriptive study of angiogenesis and neuroblastoma markers that may include O6methylguanine-methyltransferase (MGMT) status, immunohistochemistry and immunofluorescence markers on tumour samples (such as microvessel density (MVD), CD31, Ki67, NRP1, VEGFR-1, VEGFR-2, C-KIT), DNA/RNA extraction from tissue sections for tumour mutation screening and tumour expression profiling - A preliminary correlation of the different biomarkers [Fc/KIR polymorphisms, Antibody – Dependent Cellular Toxicity (ADCC), and Anti-Drug Antibodies (ADAs)] will be made with parameters of anti-tumour activity (response rate, PFS and OS). PK parameters (dinutuximab beta trough levels) for this chemo-immunotherapy regimen will be described. Patient Population Children and young adults aged 1 to 21 years of age with relapsed/refractory neuroblastoma. Sample Size Approximately 224 patients, including 160 for the bevacizumab randomisation and 64 for the dinutuximab beta amendment. Trial Duration 8 years of patient recruitment, 5 years of patient follow up BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 13 of 157 BEACON-Neuroblastoma Trial Protocol Abbreviations ADA ANTI-DRUG ANTIBODIES ADCC ANTIBODY – DEPENDENT CELL-MEDIATED CYTOTOXICITY AE ADVERSE EVENT AESI ADVERSE EVENT OF SPECIAL INTEREST AFSAPPS COMPETENT AUTHORITY FOR FRANCE ALT ALANINE AMINOTRANSFERASE ANC ABSOLUTE NEUTROPHIL COUNT APPT ACTIVATED PARTIAL THROMBOPLASTIN TIME ASCT AUTOLOGOUS STEM CELL TRANSPLANTATION AST ASPARTATE AMINOTRANSFERASE AUC AREA UNDER THE CURVE AR ADVERSE REACTION BIT BEVACIZUMAB + IRINOTECAN + TEMOZOLOMIDE ARM BM BONE MARROW BP BLOOD PRESSURE BSA BODY SURFACE AREA BT BEVACIZUMAB + TEMOZOLOMIDE ARM BTTo BEVACIZUMAB + TEMOZOLOMIDE + TOPOTECAN ARM CI CHIEF INVESTIGATOR CIs CONFIDENCE INTERVALS COG CHILDREN’S ONCOLOGY GROUP CNS CENTRAL NERVOUS SYSTEM CR COMPLETE RESPONSE CRF CASE REPORT FORM CR UK CANCER RESEARCH UK CRCTU CANCER RESEARCH UK CLINICAL TRIALS UNIT (UNIVERSITY OF BIRMINGHAM) CRN CLINICAL RESEARCH NETWORK CSR CLINICAL STUDY REPORT CT COMPUTERISED TOMOGRAPHY CTC COMMON TERMINOLOGY CRITERIA CTCAE COMMON TERMINOLOGY CRITERIA FOR ADVERSE EVENTS CXR CHEST X-RAY dBT DINUTUXIMAB BETA + TEMOZOLOMIDE ARM dBTTo DINUTUXIMAB BETA + TEMOZOLOMIDE + TOPOTECAN ARM DCX DOUBLECORTIN DLT DOSE LIMITING TOXICITY DMC DATA MONITORING COMMITTEE DNA DEOXYRIBONUCLEIC ACID ECHO ECHOCARDIOGRAM ECOG EASTERN COOPERATIVE ONCOLOGY GROUP EFS EVENT FREE SURVIVAL EMA EUROPEAN MEDICINES AGENCY ERDC ELECTRONIC REMOTE DATA CAPTURE EOT END OF TREATMENT FFPE FORMALIN-FIXED PARAFFIN EMBEDDED GCP GOOD CLINICAL PRACTICE G-CSF GRANULOCYTE COLONY STIMULATING FACTOR BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 14 of 157 BEACON-Neuroblastoma Trial Protocol GFR GM-CSF GGT GP GPOH HR IB ICF ICH IMP INR INRC INRG INSS IRF ISF IT ITCC IV MGMT MIBG MHRA MRD MRI MSKCC MTD MYCN NANT NCI NCS NR OS OTC PCP PD PFS PHOX2B PI PIS PK PMA PRES PO PPTP PR REC RECIST RNA GLOMERULAR FILTRATION RATE GRANULOCYTE-MONOCYTE COLONY STIMULATING FACTOR GAMMA-GLUTAMYL TRANSPEPTIDASE GENERAL PRACTITIONER GERMAN SOCIETY FOR PAEDIATRIC ONCOLOGY & HAEMATOLOGY HEART RATE INVESTIGATOR BROCHURE INFORMED CONSENT FORM INTERNATIONAL CONFERENCE ON HARMONISATION INVESTIGATIONAL MEDICINAL PRODUCT INTERNATIONAL NORMALISED RATIO INTERNATIONAL NEUROBLASTOMA RESPONSE CRITERIA INTERNATIONAL NEUROBLASTOMA RISK GROUP INTERNATIONAL NEUROBLASTOMA STAGING SYSTEM INSTITUTIONAL REVIEW BOARD INVESTIGATOR SITE FILE IRINOTECAN + TEMOZOLOMIDE ARM INNOVATIVE THERAPIES FOR CHILDREN WITH CANCER INTRAVENOUS O6-METHYGUANINE METHYLTRANSFERASE META-IODO-BENZYL-GUANIDINE MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY MINIMAL RESIDUAL DISEASE MAGNETIC RESONANCE IMAGING MEMORIAL SLOAN KETTERING CANCER CENTRE MAXIMUM TOLERATED DOSE MYELOCYTOMATOSIS VIRAL RELATED ONCOGENE NEW AGENTS FOR NEUROBLASTOMA THERAPY NATIONAL COORDINATING INVESTIGATOR NATIONAL CO-SPONSOR NO RESPONSE OVERALL SURVIVAL OVER THE COUNTER PNEUMOCYSTIS CARNI PNEUMONITIS PROGRESSSIVE DISEASE PROGRESSION FREE SURVIVAL PAIRED-LIKE HOMEOBOX2B PRINCIPAL INVESTIGATOR PATIENT INFORMATION SHEET PHARMACOKINETICS POPULATION-MODELLING ANALYSIS POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME ORALLY PAEDIATRIC PRECLINICAL TESTING PROGRAM PARTIAL RESPONSE RESEARCH ETHICS COMMITTEE RESPONSE EVALUATION CRITERIA IN SOLID TUMOURS RIBONUCLEIC ACID BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 15 of 157 BEACON-Neuroblastoma Trial Protocol RTKI RT-qPCR SAE SAR SCT SD SFOP SIOPEN SNP SPC SUSAR SWFI T TH TMA TMG TSC TTo TVD UAR UKCCSG ULN VTE VEGF VGPR WMA RECEPTOR TYROSINE KINASE INHIBITORS REVERSE TRANSCRIPTASE QUANTITATIVE POLYMERASE CHAIN REACTION SERIOUS ADVERSE EVENT SERIOUS ADVERSE REACTION STEM CELL TRANSPLANT STABLE DISEASE FRENCH SOCIETY OF PAEDIATRIC ONCOLOGY INTERNATIONAL SOCIETY PAEDIATRIC ONCOLOGY EUROPEAN NEUROBLASTOMA GROUP SINGLE NUCLEOTIDE POLYMORPHISM SUMMARY OF PRODUCT CHARACTERISTICS SUSPECTED UNEXPECTED SEVERE ADVERSE REACTION STERILE WATER FOR INJECTION TEMOZOLOMIDE ARM TYROSINE HYDROXYLASE TISSUE MICROARRAY TRIAL MANAGEMENT GROUP TRIAL STEERING COMMITTEE TEMOZOLOMIDE + TOPOTECAN ARM TOPOTECAN, VINCRISTINE & DOXORUBICIN UNEXPECTED ADVERSE REACTION UNITED KINGDOM CHILDREN’S CANCER STUDY GROUP UPPER LIMIT OF NORMAL VENOUS THROMBO-EMBOLISM VASCULAR ENDOTHELIAL GROWTH FACTOR VERY GOOD PARTIAL RESPONSE WORLD MEDICAL ASSOCIATION FORMULAE Mosteller formula: BSA (m²) = BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 16 of 157 BEACON-Neuroblastoma Trial Protocol Table of Contents Trial Synopsis ...................................................................................................................................... 12 Title .................................................................................................................................................... 12 Trial Design ........................................................................................................................................ 12 Objectives .......................................................................................................................................... 12 Outcome Measures............................................................................................................................ 12 Patient Population .............................................................................................................................. 13 Sample Size ....................................................................................................................................... 13 Trial Duration...................................................................................................................................... 13 Abbreviations ..................................................................................................................................... 14 1. Background and Rationale ............................................................................................................. 22 1.1 Background............................................................................................................................ 22 1.1.1 Background for the dinutuximab beta amendment............................................................ 28 1.2 Trial Rational.......................................................................................................................... 29 1.2.1 Justification for design ....................................................................................................... 29 1.2.2 Rationale for patient population ......................................................................................... 30 1.2.3 Benefit-risk assessment .................................................................................................... 31 1.2.4 Rationale for the selected backbone schedules: Temozolomide, irinotecan + temozolomide and temozolomide + topotecan .............................................................................. 31 1.2.5 Rationale for dosing schedule of bevacizumab................................................................. 32 1.2.6 Rationale for evaluating chemo-immunotherapy in the BEACON-Neuroblastoma Trial... 32 1.2.7 Rationale for dosing schedule of dinutuximab beta........................................................... 33 1.2.8 Rationale for the use of biomarker studies ........................................................................ 34 1.3 Relevance and future importance ......................................................................................... 35 2. Objectives and Outcome Measures ............................................................................................. 36 2.1 Objectives .............................................................................................................................. 36 2.2 Outcome Measures ............................................................................................................... 37 3. Trial Design ..................................................................................................................................... 37 3.1 Randomisation....................................................................................................................... 37 3.2 Duration of treatment............................................................................................................. 38 3.3 Frequency and duration of follow-up ..................................................................................... 38 4. Eligibility.......................................................................................................................................... 39 4.1 Lifestyle guidelines ................................................................................................................ 39 5. Schedule of activities..................................................................................................................... 39 6. Screening and Consent ................................................................................................................. 40 6.1 Informed Consent .................................................................................................................. 40 6.2 Screening............................................................................................................................... 41 7. Trial Entry........................................................................................................................................ 42 7.1 Procedure for online patient randomisation........................................................................... 42 7.2 Emergency Randomisation ................................................................................................... 42 8. Treatment Details ........................................................................................................................... 43 8.1 Definition of Investigational Medicinal Products (IMPs) ........................................................ 43 9. Bevacizumab randomisation......................................................................................................... 43 9.1 Eligibility criteria for the bevacizumab randomisation............................................................ 43 9.1.1 Inclusion criteria for the bevacizumab randomisation ....................................................... 43 9.1.2 Exclusion criteria for the bevacizumab randomisation ...................................................... 44 9.2 Schedule of activities for the bevacizumab randomisation ................................................... 45 BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 17 of 157 BEACON-Neuroblastoma Trial Protocol 9.3 Trial Therapy (bevacizumab randomisation) ......................................................................... 49 9.3.1 Bevacizumab randomisation trial treatment ...................................................................... 49 9.4 Treatment Schedule..................................................................................................................... 51 9.4.1 Day 1 of Cycle 1 ................................................................................................................ 51 9.4.2 Day 1 of subsequent cycles............................................................................................... 51 9.4.3 Post Cycle 6 (For patients continuing to Cycle 7-12) ........................................................ 52 9.4.4 End of Treatment ............................................................................................................... 52 9.4.5 Treatment Duration............................................................................................................ 52 9.5 Dose Modifications for the bevacizumab randomisation ....................................................... 53 9.5.1 Dose Modifications for AEs due to chemotherapy - for the bevacizumab randomisation. 56 9.5.2 Bevacizumab – Infusion-related Reaction/Infusional Site Extravasation Management Guidelines ...................................................................................................................................... 62 9.5.3 Bevacizumab - Treatment Delays ..................................................................................... 63 9.5.4 Bevacizumab - Discontinuation ........................................................................................ 64 9.5.5 Bevacizumab - Toxicity Management guidelines .............................................................. 65 9.6 Central Venous Access Device (CVAD)................................................................................ 67 10 Dinutuximab beta and topotecan randomisations...................................................................... 68 10.1 Eligibility for the dinutuximab beta randomisation ................................................................. 68 10.1.1 Inclusion criteria for the dinutuximab beta randomisation ............................................. 68 10.1.2 Exclusion criteria for the dinutuximab beta randomisation ............................................ 69 10.2 Schedule of events for the dinutuximab beta and topotecan randomisations....................... 70 10.3 Trial therapy (dinutuximab beta and topotecan randomisations) .......................................... 74 10.3.1 Dinutuximab beta and topotecan trial treatment................................................................ 75 10.4 Treatment Schedule .............................................................................................................. 76 10.4.1 Day 1 of Cycle 1 ............................................................................................................ 76 10.4.2 Day 1 of subsequent cycles........................................................................................... 76 10.4.3 Post Cycle 6 (For patients continuing to Cycle 7-12 on chemotherapy only) ............... 77 10.4.4 End of Treatment ........................................................................................................... 77 10.4.5 Treatment Duration............................................................................................................ 78 10.4.6 Cross-over ......................................................................................................................... 78 10.5 Dose Modifications – dinutuximab beta and topotecan randomisations ............................... 79 10.5.1 Dose modifications for dinutuximab beta specific toxicities .......................................... 79 10.5.2 Dose modifications for haematological toxicity.............................................................. 81 10.5.3 Dose modifications for hepatic toxicity .......................................................................... 82 11 Treatment Compliance................................................................................................................... 84 12 Supportive Treatment .................................................................................................................... 84 12.1 Nausea and Vomiting ............................................................................................................ 84 12.2 Growth Factors ...................................................................................................................... 84 12.3 Fever and neutropenia .......................................................................................................... 84 12.4 Blood products....................................................................................................................... 84 12.5 Pneumocystis jirovecii pneumonia (PJP) prophylaxis ........................................................... 84 12.6 Management of side effects caused by non-selective NSAIDs as cyclooxygenase (COX) type I and II inhibitors ......................................................................................................................... 84 12.7 Supportive care during Dinutuximab beta infusion................................................................ 85 12.7.1 Pain Management.......................................................................................................... 85 12.7.2 Prevention of dinutuximab beta related infusion reactions............................................ 86 13 Concomitant Medication................................................................................................................ 87 14 Assessments .................................................................................................................................. 87 BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 18 of 157 BEACON-Neuroblastoma Trial Protocol 14.1 Response assessment .......................................................................................................... 88 15 Biomarkers...................................................................................................................................... 88 15.1 Blood sampling safety ........................................................................................................... 88 15.2 MRI-derived functional imaging biomarkers of angiogenesis................................................ 90 15.3 Molecular monitoring mRNA.................................................................................................. 90 15.4 Neuroblastoma exploratory biomarker analyses ................................................................... 90 15.5 Sample Collection.................................................................................................................. 92 15.5.1 Peripheral blood samples .............................................................................................. 92 15.5.2 Bone Marrow Samples .................................................................................................. 92 15.5.3 Archival tumour samples ............................................................................................... 92 16 Patient Follow Up ........................................................................................................................... 93 16.1 Patient Withdrawal................................................................................................................. 93 17 Pharmaceutical Information .......................................................................................................... 94 17.1 Definition of Investigational Medicinal Product ...................................................................... 94 17.2 Bevacizumab ......................................................................................................................... 94 17.2.1 Bevacizumab - Drug Supply .......................................................................................... 94 17.2.2 Bevacizumab - Ordering ............................................................................................... 94 17.2.3 Bevacizumab - Formulation, Packaging and Labelling ................................................. 94 17.2.4 Bevacizumab - Preparation and Dispensing ................................................................. 95 17.2.5 Compatibility information ............................................................................................... 95 17.2.6 Bevacizumab - Administration ....................................................................................... 95 17.2.7 Bevacizumab – Accountability....................................................................................... 96 17.2.8 Bevacizumab - Destruction............................................................................................ 96 17.3 Cyclophosphamide ................................................................................................................ 96 17.4 Dinutuximab beta................................................................................................................... 96 17.5 Irinotecan ............................................................................................................................... 96 17.5.1 Irinotecan - Drug Supply ............................................................................................... 96 17.5.2 Irinotecan - Formulation, Packaging and Labelling ....................................................... 96 17.5.3 Irinotecan - Preparation and Dispensing ....................................................................... 97 17.5.4 Compatibility information ............................................................................................... 97 17.5.5 Irinotecan - Administration ............................................................................................. 97 17.6 Temozolomide ....................................................................................................................... 97 17.6.1 Temozolomide – Drug Supply ....................................................................................... 97 17.6.2 Temozolomide - Formulation, Packaging and Labelling ............................................... 97 17.6.3 Temozolomide - Administration ..................................................................................... 97 17.7 Topotecan.............................................................................................................................. 98 17.7.1 Topotecan - Drug Supply.............................................................................................. 98 17.7.2 Topotecan - Formulation, Packaging and Labelling ..................................................... 98 17.7.3 Topotecan - Preparation and Dispensing ..................................................................... 98 17.7.4 Topotecan - Compatibility information ........................................................................... 98 17.7.5 Topotecan - Administration........................................................................................... 99 18 Adverse Event Reporting .............................................................................................................. 99 18.1 Reporting Requirements........................................................................................................ 99 18.1.1 Adverse Events (AE) ..................................................................................................... 99 18.1.2 AESIs of Bevacizumab .................................................................................................. 99 18.1.3 Serious Adverse Advents (SAE).................................................................................... 99 18.1.4 Reporting period .......................................................................................................... 100 18.2 Reporting Procedure ........................................................................................................... 100 BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 19 of 157 BEACON-Neuroblastoma Trial Protocol 18.2.1 Site............................................................................................................................... 100 18.2.2 Trial Office ................................................................................................................... 102 18.2.3 Reporting to the Competent Authority and main Research Ethics Committee ........... 102 18.2.4 Investigators ................................................................................................................ 102 18.2.5 Data Monitoring Committee ......................................................................................... 102 18.2.6 Manufacturer of Investigational Medicinal Product...................................................... 102 19 Data Handling and Record Keeping ........................................................................................... 103 19.1 Data Collection .................................................................................................................... 103 19.2 Archiving .............................................................................................................................. 103 20 Quality Management .................................................................................................................... 103 20.1 Site Set-up and Initiation ..................................................................................................... 103 20.2 On-site Monitoring ............................................................................................................... 104 20.3 Central Monitoring ............................................................................................................... 104 20.4 Audit and Inspection ............................................................................................................ 104 20.5 Notification of Serious Breaches ......................................................................................... 104 21 End of Trial Definition .................................................................................................................. 105 22 Statistical Considerations ........................................................................................................... 105 22.1 Trial Design.......................................................................................................................... 105 22.2 Definition of Outcome Measures ......................................................................................... 106 22.2.1 Primary ........................................................................................................................ 106 22.2.2 Secondary.................................................................................................................... 106 22.2.3 Exploratory/Tertiary ..................................................................................................... 106 22.3 Sample Size......................................................................................................................... 106 22.4 Interim and Main Analyses of Outcome Measures.............................................................. 108 22.4.1 Planned Interim Analyses ............................................................................................ 108 22.4.2 Main Analysis............................................................................................................... 108 22.5 Stopping Guidelines ............................................................................................................ 110 23 Trial Organisational Structure..................................................................................................... 110 23.1 Coordinating Sponsor .......................................................................................................... 110 23.2 Co-Sponsor Centres ........................................................................................................... 110 23.3 Relationship of trial committees........................................................................................... 112 23.4 Trial Management Group..................................................................................................... 112 23.5 Trial Steering Committee ..................................................................................................... 112 23.6 Data Monitoring Committee................................................................................................. 112 23.7 Finance ................................................................................................................................ 113 23.8 NIHR CRN Portfolio ............................................................................................................. 113 24 Ethical Considerations ................................................................................................................ 113 25 Confidentiality and Data Protection ........................................................................................... 114 26 Insurance and Indemnity ............................................................................................................. 115 27 Publication Policy ........................................................................................................................ 116 28 Reference List............................................................................................................................... 117 Appendix 1 – WMA Declaration of Helsinki .................................................................................... 124 Appendix 2 - Definition of Adverse Events ..................................................................................... 127 Appendix 3 - Common Toxicity Criteria Grading ........................................................................... 129 Appendix 4 – RECIST Criteria 1.1 .................................................................................................... 130 Appendix 5 – Tumor Response at Metastatic Soft Tissue and Bone Sites (Park et al. 2017) ... 133 Appendix 6 - CURIE & SIOPEN scoring methods for neuroblastoma ......................................... 134 Appendix 7 – Temozolomide Dosing............................................................................................... 136 BEACON-Neuroblastoma Protocol_vn 8.0_vd _07Mar2023 Page 20 of 157 BEACON-Neuroblastoma Trial Protocol Appendix 8 – Blood Pressure Levels by Age and Height Percentile for Children and Adolescents ....................................................................................................................................... 139 Appendix 9 – Height for Age Chart - Girls ...................................................................................... 144 Appendix 10 – Height for Age Chart - Boys.................................................................................... 149 Appendix 11 – Lansky and Karnofsky/ECOG Scales .................................................................... 154 Appendix 12 – Tanner Staging ......................................................................................................... 156 Appendix 13 – Clinical studies of anti-GD2 therapies in combination with chemotherapy ...... 157 LIST OF TABLES Table 1 - Second line chemotherapy regimens tested in phase II in relapsed or refractory neuroblastoma since 2000 ..........
Url: /Media/UHS-website-2019/Docs/PaediatricOncology/beacon-protocol-v8.0-07mar2023-signed.pdf

WHP Funding Call EOI_01.03.24

Description: Funding Call – Round 1 - PILOT Expression of Interest About Wessex Health Partners: 1. Wessex Health Partners (WHP) is the region’s academic health science strategic partnership of NHS and HEI organisations across Hampshire and the Isle of Wight and Dorset including Health Innovation Wessex. Our common purpose is through working in partnership, to accelerate improvements in health and social care through research, innovation, and training for the benefit of the public and patients in Wessex and globally. 2. Our ambitions are to * improve the region’s collective ability to tackle the greatest challenges facing the Wessex health and care system, and * generate greater collaborative and interdisciplinary research to speed the discovery, development and deployment of innovation at scale 3. As partners, we do this through seeking alignment within our strategies, working collaboratively to produce synergy, learning together and sharing knowledge nationally and internationally. 4. The strategic workstreams of WHP are: * Connecting research and innovation to the health and care challenges in Wessex * Collaborating to increase research capability and capacity for shared themes * Systematic translation and adoption of innovation to accelerate and amplify benefits * Developing the workforce to discover, develop, and deploy research and innovation * Enhancing discoverability of information and data through our Secure Data Environment 5. Within Wessex Health Partners, sits the Wessex Experimental Medicine Network (WEMN), which brings together our partners from across Wessex to collaboratively develop and deliver experimental medicine, aligned and in collaboration with the activities of the NIHR Southampton Biomedical Research Centre, and of relevance to the patient and public. Please see appendix one for relevant information on WEMN. Wessex Health Partners Funding Applications: * Wessex Heath Partners (WHP) has been established to support new ways of working. * A total sum of up to £200k is available per annum to pump-prime activities which accelerate the impact of the WHP strategic alliance. * A further £50k per annum is available to support activities aligned with the aims and themes of the Wessex Experimental Medicine Network (WEMN) (Appendix 1). * Expressions of interest are now invited to this pilot (round 1) for the WHP and WEMN pump-prime funding. * Please note that the closing date for this pilot is 28th March 2024, however, we expect to open for further opportunities in the near future. * An overview of the process and guidance is provided in Appendix 2. * Potential applicants are advised to discuss their idea and application with their founding partner representative on the WHP steering group, listed at Appendix 3. * The process will include an expression of interest (EOI) which if successful is followed by a full application. However, an application of less that £5k may be awarded at the EOI stage. * Lead applicants must be a substantive employee of a WHP founding partner. * Applications must be sponsored by one of the WHP strategic alliance founding partner organisations (Appendix 4) * Applicants should emphasise the ways in which the activity will provide a unique contribution to existing health and care, providing clear evidence of its added value over and above ‘business as usual’. * Applications are for pump-prime funding and should indicate which funding streams will be targeted for future funding. Wessexhealthpartners.org.uk @wessexhp Wessex Health Partners 1. Proposed Name of Project / Initiative 2. Which funding stream are you targeting for future funding? 3. Lead Contact Details Name: Title: Position: Employing Organisation: Email: Phone: 4. WHP Partner Organisations involved (whilst not all partners need to be involved, an ambition of WHP is to increase pan-Wessex collaboration) Organisation Tick Bournemouth University AECC University College NHS Dorset Integrated Care Board Dorset County Hospital NHS FT Dorset HealthCare University NHS FT University Hospital Dorset NHS FT University of Portsmouth University of Southampton HIoW Integrated Care Board Hampshire Hospitals NHS FT Portsmouth Hospitals University NHS FT Solent NHS FT Southern Health NHS FT University Hospital Southampton NHS FT Health Innovation Wessex 5. Signed off by WHP Board Member of Sponsor Organisation: Sponsor organisation must be a founding partner of the WHP strategic alliance – Appendix 4 Name:____________________________ Signature:_________________________ Date:_____________________________ 6. List of collaborators for your project/initiative (Please also identify the overall lead and co-leads, their organisational affiliations and current roles): Name Organisation Job Role 7. Provide a high-level description of the project/initiative (max 150 words): 8. Summarise how the project/initiative will accelerate the impact of the Wessex Health Partners strategic alliance (max 150 words): 9. Summarise how your project/initiative would add value to what is already underway or planned (max 150 words): 10.Proposed Management structure of the project/initiative (max 150 words): 11. Please explain why this is a priority for the Wessex population. (Max 100 words) 12. Summarise how the project/initiative has already engaged, or has plans to engage in the future, with other WHP founding partners (max 150 words): 13. Briefly explain patient and public involvement and engagement (PPIE) plans associated with the proposed project/initiative (Max 100 words): 14. What is the funding sum you are requesting for your project/initiative? Please provide a breakdown of what the funding will be used for. 15. What is the proposed project start date and duration? 16. Does your project/initiative sit within the aims and themes of the WEMN? Yes No Unsure If you answered YES to the above question, please complete the following sections. Please note this does not preclude you from being considered for WHP funding. 17. Which of the following scientific aims below does your project/initiative fit? Aim Tick all that apply Identifying target interventions through mechanistic exploration in human (metabolic/immune/infective/behavioural/environmental) Testing and refining interventions, including vaccines and therapeutics, in patients/healthy volunteers to demonstrate proof-of-concept Evaluating efficacy of novel nutritional, pharmaceutical, physical, behavioural and digital interventions to promote resilience and prevent/manage disease Developing validated biomarkers/phenomarkers and predictive algorithms to individualise interventions relevant to realworld NHS use Translating our innovations for patient and population benefit through effective dissemination into national/international guidelines and policy 18. Within which of the following WEMN five research themes does your project/initiative fit? WEMN Research Theme Tick all that apply 1. Nutrition, Lifestyle and Metabolism (NLM) 2. Respiratory and Allergy (RA) 3. Data, Health and Society (DHS) 4. Microbiology, Immunology and Infection (MII) 5. Perioperative and Critical Care (PCC) The closing date for receipt of applications for this pilot is 28th March 2024, however, we expect to open for further opportunities in the near future. Please submit applications to Wessex Health Partners: enquiries@wessexhp.org.uk We are aiming to have regular funding opportunities and our second call will be for 21st June 2024. Wessexhealthpartners.org.uk @wessexhp Wessex Health Partners Appendix 1 Wessex Experimental Medicine Network (WEMN) The Wessex NIHR Experimental Medicine Network (WEMN) brings together NHS and HEI partners from across Wessex to collaboratively develop and deliver experimental medicine aligned with the activities of the NIHR Southampton Biomedical Research Centre (BRC) and of relevance to the patient and public that we serve. The clinical director of WEMN and director of the NIHR Southampton BRC is Professor Mike Grocott and the senior programme manager for the BRC is Kay Mitchell. Our scientific aims are to develop individualised interventions (precision medicine) to enhance physiological, metabolic and psychological resilience to disease, injury and the consequences of ageing by: * identifying target interventions through mechanistic exploration in human (metabolic/immune/infective/behavioural/environmental) * testing and refining interventions, including vaccines and therapeutics, in patients/healthy volunteers to demonstrate proof-of-concept * evaluating efficacy of novel nutritional, pharmaceutical, physical, behavioural and digital interventions to promote resilience and prevent/manage disease * developing validated biomarkers/phenomarkers and predictive algorithms to individualise interventions relevant to real world NHS use * translating our innovations for patient and population benefit through effective dissemination into national/international guidelines and policy Our research themes are: 1. Nutrition, Lifestyle and Metabolism (NLM): improving health and resilience across the lifecourse, addressing patient and population needs through improving diet quality/nutrient status, smoking/alcohol behaviours, physical activity, obesity/body composition and cardiometabolic musculoskeletal and immune health. 2. Respiratory and Allergy (RA): delivering preventive interventions for allergy and respiratory disease, identifying biomarkers to provide earlier and more accurate diagnosis and personalise therapy, and utilising our ex-vivo models and innovative trial designs to accelerate identification of new therapeutic approaches. 3. Data, Health and Society (DHS): moving beyond data science to harness computer science, artificial intelligence and exploration of societal implications to create a trusted and trustworthy learning healthcare system. 4. Microbiology, Immunology and Infection (MII): delivering innovative solutions to infectious threats and help overcome antimicrobial resistance by conducting experimental evaluation of novel vaccines and other prevention strategies, as well as advanced diagnostics and therapies. 5. Perioperative and Critical Care (PCC): developing, evaluating and individualising interventions to promote, rebuild and maintain resilience across surgical and critical care pathways. Wessexhealthpartners.org.uk @wessexhp Wessex Health Partners Appendix 2 Overview of Process 1. Idea: an employee of a WHP founding partner (the lead) has an idea which they consider has potential to accelerate achievement of the WHP ambitions or WEMN aims. 2. Initial discussion: The lead discusses the idea with their employing organisations’ WHP Founding Partner Steering Group (SG) or Board member who will provide a steer on the ambitions of WHP and consider with the lead whether the idea falls within the remit of this call, i.e., that it has potential to accelerate achievement of the WHP ambitions or WEMN aims. 3. General queries and further guidance: Please contact the WHP core team at: enquiries@wessexhp.org.uk 4. Complete Expression of Interest (EOI): The lead will complete an EOI including any requests for funding and other support. 5. Assessment of EOI: EOIs will be reviewed by the WHP SLT. Those considered to fall within the scope of the Wessex Experimental Medicine Network (WEMN) will be reviewed by the WHP SLT with the WEMN Director and BRC Senior Programme Manager (or nominated individuals). Whilst applications will be judged on quality, WHP will be seeking to promote equity of funding awards across founding partners. Founding partners, may be asked by the WHP SLT, to prioritise applications. 6. Decision EOI: If funding request is <£5k the decision to fund or not will be made by the EOI reviewers. If funding request is >£5k, and considered within remit, including the remit of the WEMN, applicants will be asked to complete a full application. 7. Complete full application: A member of the WHP core team will work with the lead to develop the idea further and complete the full application. This may also include referring the lead to potential collaborators and other support within Wessex. As for the EOI, applications relating to experimental medicine aligned to the NIHR Southampton Biomedical Research Centre (BRC) themes will be referred to the Director of the Wessex Experimental Medicine Network and BRC Senior Programme Manager. 8. Decision Full Application: Full applications will be reviewed by the WHP SLT. The WHP SLT will seek additional expertise and advice as needed including from the WEMN. The SLT will make a recommendation to the WHP steering group on whether to fund and to what extent. Members of the WHP steering group who have a conflict of interest (COI) will declare their COI and excuse themselves from the relevant decision. As with the EOIs, whilst applications will be judged on quality, WHP is seeking to promote new pan-Wessex collaborations and equity of funding awards across founding partners. The decision to award or not is final. 9. Communication: Decisions will be communicated to the lead applicant and copied to the relevant WHP Board and Steering Group member. For successful applicants the award letter will detail the support that will be provided, and the terms and conditions. 10. Feedback: Detailed feedback will not routinely be provided. There will be no process to appeal a decision. Unsuccessful applications may be resubmitted. 11. Reporting: Recipients of WHP awards will be required to provide written and verbal reports on request on at least a 6 monthly basis. Wessexhealthpartners.org.uk @wessexhp Wessex Health Partners Appendix 3 WHP Steering Group members Name Title Email Bournemouth University Jane Murphy Deputy Dean for Research, Faculty of Health & Social Sciences jmurphy@bournemouth.ac.uk NHS Dorset ICB Ash Boreham Deputy Chief Officer Strategy and Transformation NHS Dorset Ashleigh.boreham@nhsdorset.nhs.uk Dorset County Hospital NHS FT Nathan Curtis Clinical Lead for Research & Development Nathan.Curtis@dchft.nhs.uk Dorset County Hospital NHS FT Sarah Doyle Clinical Lead & Head of Research Sarah.Doyle@dchft.nhs.uk Dorset HealthCare University NHS FT Paul Walters Associate Medical Director for Research & Development Paul.Walters1@nhs.net Dorset HealthCare University NHS FT Carole Walford Lead for Innovation & Research carole.walford@nhs.net University Hospital Dorset NHS FT Rob Willington Clinical Director for Research and Development robert.willington@uhd.nhs.uk AECC University College Julie Northam Head of Research jnortham@aecc.ac.uk University of Portsmouth Joy Watts Associate Dean (Research and Innovation) Joy.Watts@port.ac.uk University of Southampton Peter Smith Director of Institute for Life Sciences P.J.Smith@soton.ac.uk HIoW ICB Vicki Osman-Hicks Deputy Chief Medical Officer (Mental Health, Learning Disability and Autism) vicki.osman-hicks@nhs.net Hampshire Hospitals NHS FT Natasha Chigbo Head of Research and Development natasha.chigbo@hhft.nhs.uk Portsmouth Hospitals University NHS FT Alex Jones Head of Research Operations alexandra.jones@porthosp.nhs.uk Solent NHS FT Sarah Williams Director of Research & Improvement sarah.williams@solent.nhs.uk Southern Health NHS FT Peter Phiri Director of Research & Innovation peter.phiri@southernhealth.nhs.uk University Hospital Southampton NHS FT Karen Underwood Director of Research & Development Karen.Underwood@uhs.nhs.uk Health Innovation Wessex Joe Sladen Associate Director Innovation Adoption joe.sladen@hiwessex.net University Hospital Southampton NHS FT Saul Faust NIHR CRN Clinical Director s.faust@soton.ac.uk University Hospital Southampton NHS FT Mike Grocott NIHR WEMN Clinical Director mike.grocott@soton.ac.uk University of Southampton Alison Richardson NIHR Academic Research Centre Director alison.richardson@soton.ac.uk University of Southampton Cathy Bowen NIHR Academic Research Centre Director Designate C.J.Bowen@soton.ac.uk University Hospital Southampton NHS FT Chris Kipps Secure Data Environment Director christopher.kipps@uhs.nhs.uk University of Southampton Issy Reading Research Support Service Director I.C.Reading@soton.ac.uk Southern Health NHS FT Heather Mitchell Executive Director of Strategy & Infrastructure Transformation / Strategy Lead HIOW locality Heather.Mitchell@southernhealth.nhs.uk Wessexhealthpartners.org.uk @wessexhp Wessex Health Partners Appendix 4 WHP Board Members Organisation Name Title Email Bournemouth University Anand Pandyan Executive Dean apandyan@bournemouth.ac.uk NHS Dorset Integrated Care Board Paul Johnson Chief Medical Officer paul.johnson@nhsdorset.nhs.uk Dorset County Hospital NHS FT Alastair Hutchison Executive Medical Director alastair.hutchison@dchft.nhs.uk Dorset HealthCare University NHS FT Faisal Sethi Chief Medical Officer faisil.sethi1@nhs.net University Hospital Dorset NHS FT Peter Wilson Chief Medical Officer Peter.Wilson@uhd.nhs.uk AECC University College Kevin McGhee Deputy Vice-Chancellor kmcghee@aecc.ac.uk University of Portsmouth NHS FT Richard Thelwell Interim Executive Dean, Science and Health Richard.Thelwell@port.ac.uk University of Southampton Diana Eccles Dean of Medicine D.M.Eccles@soton.ac.uk HIoW Integrated Care Board Lara Alloway Chief Medical Officer lara.alloway1@nhs.net Hampshire Hospitals NHS FT Shirlene Oh Chief Strategy and Population Health Officer shirlene.oh@hhft.nhs.uk Portsmouth Hospitals University NHS FT Anoop Chauhan Executive Director of Research anoop.chauhan@porthosp.nhs.uk Solent NHS FT Daniel Baylis Chief Medical Officer and Deputy CEO daniel.baylis@solent.nhs.uk Southern Health NHS FT Viki Laakkonen Interim Chief Medical Officer Victoria.Laakkonen@southernhealth.nhs.uk University Hospital Southampton NHS FT Karen Underwood Director or Research & Development Karen.Underwood@uhs.nhs.uk Health Innovation Wessex Nicola Bent Acting Chief Executive Officer nicola.bent@hiwessex.net Wessexhealthpartners.org.uk @wessexhp Wessex Health Partners
Url: /Media/Southampton-Clinical-Research/Downloads/WHP-Funding-Call-EOI-01.03.24.docx

Segmentectomy (VATS or RATS) - patient information

Description: This booklet explains what a segmentectomy is, what the procedure involves, and the benefits and risks.
Url: /Media/UHS-website-2019/Patientinformation/Cardiovascular-and-thoracic/Segmentectomy-VATS-or-RATS-3205-PIL.pdf

Lobectomy (VATS or RATS) - patient information

Description: This booklet explains what a lobectomy is, what the procedure involves, and the benefits and risks.
Url: /Media/UHS-website-2019/Patientinformation/Cardiovascular-and-thoracic/Lobectomy-VATS-or-RATS-517-PIL.pdf

Papers Trust Board - 13 January 2026

Description: Date Time Location Chair Apologies Agenda Trust Board – Open Session 13/01/2026 9:00 - 13:00 Conference Room, Heartbeat Education Centre Jenni Douglas-Todd Diana Eccles 1 Chair’s Welcome, Apologies and Declarations of Interest 9:00 Note apologies for absence, and to hear any declarations of interest relating to any item on the Agenda. 2 Patient Story The patient story provides an opportunity for the Board to reflect on the experiences of patients and staff within the Trust and understand what the Trust could do better. 3 Minutes of Previous Meeting held on 11 November 2025 9:15 Approve the minutes of the previous meeting held on 11 November 2025 4 Matters Arising and Summary of Agreed Actions To discuss any matters arising from the minutes, and to agree on the status of any actions assigned at the previous meeting. 5 QUALITY, PERFORMANCE and FINANCE Quality includes: clinical effectiveness, patient safety, and patient experience 5.1 Briefing from the Chair of the Finance, Investment & Cash Committee 9:20 David Liverseidge, Chair 5.2 Briefing from the Chair of the People and Organisational Development 9:30 Committee Jane Harwood, Chair 5.3 Briefing from the Chair of the Quality Committee 9:40 including Maternity and Neonatal Safety 2025-26 Quarter 2 Report Tim Peachey, Chair 5.4 Chief Executive Officer's Report 9:50 Receive and note the report Sponsor: David French, Chief Executive Officer 5.5 Performance KPI Report for Month 8 10:20 Review and discuss the report Sponsor: Andy Hyett, Chief Operating Officer 5.6 11:00 5.7 11:15 5.8 11:25 5.9 11:30 5.10 11:45 5.11 11:55 5.12 12:05 5.13 12:15 6 6.1 12:25 7 12:35 8 Break Finance Report for Month 8 Review and discuss the report Sponsor: Ian Howard, Chief Financial Officer ICB System Report for Month 8 Receive and discuss the report Sponsor: Ian Howard, Chief Financial Officer People Report for Month 8 Review and discuss the report Sponsor: Steve Harris, Chief People Officer Learning from Deaths 2025-26 Quarter 2 Report Review and discuss the report Sponsor: Paul Grundy, Chief Medical Officer Attendee: Jenny Milner, Associate Director of Patient Experience Infection Prevention and Control 2025-26 Quarter 2 Report Review and discuss the report Sponsor: Natasha Watts, Acting Chief Nursing Officer Attendees: Julian Sutton, Clinical Lead, Department of Infection/Julie Brooks, Deputy Director of Infection Prevention and Control Medicines Management Annual Report 2024-25 Receive and discuss the report Sponsor: Paul Grundy, Chief Medical Officer Attendee: James Allen, Chief Pharmacist Annual Ward Staffing Nursing Establishment Review 2025 Discuss and approve the review Sponsor: Natasha Watts, Acting Chief Nursing Officer CORPORATE GOVERNANCE, RISK and INTERNAL CONTROL Annual Assurance for the NHS England Core Standards for Emergency Preparedness, Resilience and Response (EPRR) Review and discuss the report Sponsor: Andy Hyett, Chief Operating Officer Attendee: John Mcgonigle, Emergency Planning & Resilience Manager Any other business Raise any relevant or urgent matters that are not on the agenda Note the date of the next meeting: 10 March 2026 Page 2 9 Resolution regarding the Press, Public and Others Sponsor: Jenni Douglas-Todd, Trust Chair To agree, as permitted by the National Health Service Act 2006 (as amended), the Trust's Constitution and the Standing Orders of the Board of Directors, that representatives of the press, members of the public and others not invited to attend to the next part of the meeting be excluded due to the confidential nature of the business to be transacted. 10 Follow-up discussion with governors 12:45 Page 3 Agenda links to the Board Assurance Framework (BAF) 13 January 2026 – Open Session Overview of the BAF Risk 1a: Lack of capacity to appropriately respond to emergency demand, manage the increasing waiting lists for elective demand, and provide timely diagnostics, that results in avoidable harm to patients. 1b: Due to the current challenges, we fail to provide patients and their families / carers with a high-quality experience of care and positive patient outcomes. 1c: We do not effectively plan for and implement infection prevention and control measures that reduce the number of hospital-acquired infections and limit the number of nosocomial outbreaks of infection. 2a: We do not take full advantage of our position as a leading University teaching hospital with a growing, reputable, and innovative research and development portfolio, attracting the best staff and efficiently delivering the best possible treatments and care for our patients. 3a: We are unable to meet current and planned service requirements due to the unavailability of staff to fulfil key roles. 3b: We fail to develop a diverse, compassionate, and inclusive workforce, providing a more positive staff experience for all staff. 3c: We fail to create a sustainable and innovative education and development response to meet the current and future workforce needs identified in the Trust’s longer-term workforce plan. 4a: We do not implement effective models to deliver integrated and networked care, resulting in sub-optimal patient experience and outcomes, increased numbers of admissions and increases in patients’ length of stay. 5a: We are unable to deliver a financial breakeven position, resulting in: inability to move out of the NHS England Recovery Support Programme, NHS England imposing additional controls/undertakings, and a reducing cash balance impacting the Trust’s ability to invest in line with its capital plan, estates/digital strategies, and in transformation initiatives. 5b: We do not adequately maintain, improve and develop our estate to deliver our clinical services and increase capacity. 5c: Our digital technology or infrastructure fails to the extent that it impacts our ability to deliver care effectively and safely within the organisation, 5d: We fail to prioritise green initiatives to deliver a trajectory that will reduce our direct and indirect carbon footprint by 80% by 2028-2032 (compared with a 1990 baseline) and reach net zero direct carbon emissions by 2040 and net zero indirect carbon emissions by 2045. Agenda links to the BAF No Item Linked BAF risk(s) 5.5 Performance KPI Report for Month 8 5.7 Finance Report for Month 8 5.8 ICB System Report for Month 8 5.9 People Report for Month 8 5.10 Learning from Deaths 2025-26 Quarter 2 Report 5.11 Infection Prevention and Control 2025-26 Quarter 2 Report 5.12 Medicines Management Annual Report 2024-25 5.13 Annual Ward Staffing Nursing Establishment Review 2025 6.1 Annual Assurance for the NHS England Core Standards for Emergency Preparedness, Resilience and Response (EPRR) 1a, 1b, 1c 5a 5a 3a, 3b, 3c 1b 1c 1b 1b, 3a 1b Appetite (Category) Minimal (Safety) Current risk rating 4x5 20 Cautious (Experience) Minimal (Safety) 4x4 16 4x4 16 Open (Technology & Innovation) 3x4 12 Open (workforce) Open (workforce) Open (workforce) 4x5 20 4x3 12 4x4 16 Cautious (Effectiveness) 3x3 9 Cautious (Finance) 5x5 25 Target risk rating 4 x 2 Apr 6 27 3 x 2 Apr 6 27 2 x 3 Apr 6 27 3 x 2 Mar 6 27 4 x 3 Mar 12 30 4 x 2 Mar 8 30 3 x 2 Mar 6 29 3 x 2 Dec 6 25 3 x 3 Apr 9 30 Cautious (Effectiveness) Open (Technology & Innovation) Open (Technology & Innovation) 4x5 20 3x4 12 2x4 8 4 x 2 Apr 8 30 3 x 2 Apr 6 27 2 x 2 Dec 4 27 Does this item facilitate movement towards or away from the intended target risk score and appetite? Towards Away Neither x x x x x x x x x Minutes Trust Board – Open Session Date 11/11/2025 Time 9:00 – 13:00 Location Conference Room, Heartbeat Education Centre Chair Jenni Douglas-Todd (JD-T) Present Diana Eccles, NED (DE) Keith Evans, Deputy Chair and NED (KE) David French, Chief Executive Officer (DAF) Paul Grundy, Chief Medical Officer (PG) Steve Harris, Chief People Officer (SH) Jane Harwood, NED/Senior Independent Director (JH) Ian Howard, Chief Financial Officer (IH) Andy Hyett, Chief Operating Officer (AH) David Liverseidge, NED (DL) Tim Peachey, NED (TP) Alison Tattersall, NED (AT) Natasha Watts, Acting Chief Nursing Officer (NW) In attendance Craig Machell, Associate Director of Corporate Affairs and Company Secretary (CM) Lauren Anderson, Corporate Governance and Risk Manager (LA) (item 6.2) Martin de Sousa, Director of Strategy and Partnerships (MdS) (item 6.1) Lucinda Hood, Head of Medical Directorate (LH) (item 5.13) Diana Hulbert, Guardian of Safe Working Hours and Emergency Department Consultant (DH) (item 5.12) Vickie Purdie, Head of Patient Safety (VP) (item 7.3) Kate Pryde, Clinical Director for Improvement and Clinical Effectiveness (KP) (item 5.13) Scott Spencer, Health and Safety Advisor (SS) (item 7.3) 4 governors (observing) 2 members of staff (observing) 1. Chair’s Welcome, Apologies and Declarations of Interest The Chair welcomed attendees to the meeting. There were no interests to declare in the business to be transacted at the meeting. It was noted that no apologies had been received. The Chair provided an overview of meetings she had held and events that she had attended since the previous Board meeting. 2. Patient Story Item deferred to the next meeting. 3. Minutes of the Previous Meeting held on 9 September 2025 The draft minutes tabled to the meeting were agreed to be an accurate record of the meeting held on 9 September 2025, subject to a minor correction at 5.10. Page 1 4. Matters Arising and Summary of Agreed Actions The matters arising and actions were noted. • Actions 1281, 1283 and 1284 were closed. • Action 1282 was to be addressed through item 5.6 below. • In respect of action 1285, the Quality Committee would monitor progress on complaints response times. 5. QUALITY, PERFORMANCE and FINANCE 5.1 Briefing from the Chair of the Audit and Risk Committee Keith Evans was invited to present the Committee Chair’s Report in respect of the meeting held on 13 October 2025, the content of which was noted. It was further noted that: • In terms of the internal audit reports, which had been received by the committee, whilst there were a number of points for the Trust to address, no areas of significant concern had been identified. • There was a focus on ‘imposter fraud’ whereby individuals who had turned up to carry out a shift were not who they claimed to be. Whilst there had been no reported incidents at the Trust, the Trust had implemented controls at the ward level, which would be subject to testing during 2025/26. 5.2 Briefing from the Chair of the Finance, Investment & Cash Committee David Liverseidge was invited to present the Committee Chair’s Reports in respect of the meetings held on 22 September and 3 November 2025, the contents of which were noted. It was further noted that: • In September 2025, the Trust had reported that it was in line with its Financial Recovery Plan. Of the £110m Cost Improvement Programme (CIP) target, 76% had been fully developed. • The committee had reviewed the Finance Report for Month 6 (item 5.8), noting that the Trust had reported an in-month deficit of £5.4m, which was in line with the Financial Recovery Plan. • The committee had expressed concern that 17% of the CIP target was not fully developed and that the Trust was £2.5m off-track in terms of delivery of the target at Month 6. • Whilst progress had been made in terms of addressing patients with no criteria to reside and mental health patients, this remained an area of concern. • The committee considered the NHS England Medium Term Planning Framework, noting that the first submission by the Trust was due prior to Christmas 2025. 5.3 Briefing from the Chair of the People and Organisational Development Committee Jane Harwood was invited to present the Committee Chair’s Reports in respect of the meetings held on 22 September and 3 November 2025, the contents of which were noted. It was further noted that: • There continued to be little improvement in terms of the number of patients with no criteria to reside or mental health patients, which impacted staffing numbers. • The Trust was adopting a harder line in respect of its approach to violence and aggression, which included a greater willingness to exclude individuals. • The current participation rate in the Staff Survey was lower than the national average, which was likely indicative of staff morale and engagement. Page 2 • The Trust’s workforce numbers remained above plan, with limited options available to address this issue, especially in the absence of funding for restructuring costs. 5.4 Briefing from the Chair of the Quality Committee Tim Peachey was invited to present the Committee Chair’s Report in respect of the meeting held on 13 October 2025, the content of which was noted. It was further noted that: • The committee received an update in respect of mental health patients, noting that although there were significant issues in the Emergency Department, the whole pathway for these patients remained a problem. • The committee carried out a six-monthly review of the Trust’s progress against its Quality Priorities, noting that good progress had been made on four of the six priorities and two were slightly behind. 5.5 Chief Executive Officer’s Report David French was invited to present the Chief Executive Officer’s Report, the content of which was noted. It was further noted that: • NHS England had published the Medium Term Planning Framework, which was intended to encourage organisations to think beyond a 12-month time horizon and to progress the NHS 10-Year Plan. The Trust was expected to provide its first submission prior to Christmas 2025, but the detailed planning assumptions had yet to be received from NHS England. It was noted that a more detailed report on the Medium Term Planning Framework was to be received as part of the closed session of the meeting. • The Strategic Commissioning Framework had been published by NHS England, which provided welcome clarifications about the future role of integrated care boards. • The Trust had been placed into Tier 1 for both Urgent and Emergency Care and for Elective performance. There was a national expectation that trusts would have no patients waiting over 65 weeks for elective care by 21 December 2025. Where organisations had more than 100 such patients at the end of October 2025, they had been placed into Tier 1. The Trust was taking steps, including mutual aid, to attempt to address the number of long waiters, but there was insufficient capacity in the system. • Resident doctors were due to strike for a further five-day period commencing on 14 November 2025, having rejected the Government’s latest offer to resolve the ongoing dispute with the British Medical Association. • The Hampshire and Isle of Wight Integrated Care Board and NHS England South East Region had carried out a visit to the Trust’s paediatric hearing services in May 2025. The report, received in October 2025, had been positive about the service. • The Trust and the University of Southampton had been awarded £16.3m by the National Institute for Health and Care Research. The Trust was one of only four organisations out of 15 applications to receive an award. • The NHS Business Services Authority had announced the award of a £1.2bn contract to Infosys to deliver a new and enhanced workforce management system for the NHS to replace the existing Electronic Staff Record system. The 2030 target date for implementation was considered ambitious. Further details would be considered by the People and Organisational Development Committee when available. Page 3 5.6 Performance KPI Report for Month 6 Andy Hyett was invited to present the ‘spotlight’ report in respect of Diagnostics, the content of which was noted. It was further noted that: • Diagnostics performance was a key element of the pathway, as delays in diagnosis had a consequential impact on the overall length of pathways such as those for cancer and patients on a Referral To Treatment pathway. • Although there were some concerns with Diagnostics in the Trust, the Trust, generally, performed better than other organisations. The Board discussed the matters raised in the Diagnostics ‘spotlight’. This discussion is summarised below: • There had been a long-standing issue with waiting times for cystoscopy due to insufficient capacity. However, a plan was being developed to improve the situation, although it was considered appropriate that the plan should also address broader issues with urology as a whole. • There was concern regarding the availability of magnetic resonance imaging (MRI) scanners, particularly as two scanners were out-of-action. It was noted that the current set-up in terms of MRI scanners was not fit for the longer term and a strategy for the future needed to be developed. • There was a disparity between capacity and demand in respect of the neurophysiology service, as this service had previously relied on outsourcing. • Generally, activity was increasing, but overall performance appeared to be declining. There was also the additional financial challenge that Diagnostics was funded under a ‘block’ contract arrangement which did not fully take into account the demand for these services. • There were concerns about the electrical supply capacity at the Southampton General Hospital site and the ability of the Trust to expand its Diagnostic capacity with this limitation. It was considered that a better longer-term model would be for scanners at local community diagnostics centres. Actions Andy Hyett agreed to work on and present at either a future Board meeting or Trust Board Study Session the Trust’s longer-term strategy with respect to MRI scanners and imaging. Andy Hyett agreed to develop a longer-term plan for cystoscopy/urology and to report back to the Board during Quarter 4. Andy Hyett agreed to develop a long-term solution to the neurophysiology service. Andy Hyett was invited to present the Performance KPI Report for Month 6, the content of which was noted. It was further noted that: • The Trust’s Emergency Department had recorded performance of 67.6% against the four-hour standard during September 2025. The department remained busy with c.450 patients and 120 ambulance attendances per day. • There had been some initial performance impacts with the roll out of the MIYA system in the Emergency Department, but this appeared to have now been addressed with performance up to previous levels. • A number of initiatives were being introduced into the Emergency Department in order to improve performance. These included the layout of the service, pathway re-designs, having General Practitioners in the department, and arranging with non-urgent patients to attend at a scheduled time rather than waiting in the department. Page 4 • In October 2025, the Trust had recorded 363 patients waiting over 65 weeks on a Referral To Treatment pathway against a national target of no such patients by the end of December 2025. • The Trust was making use of the independent sector, weekend working, and was requesting capacity from other providers to address the number of patients waiting over 65 weeks. • The planned industrial action by resident doctors posed a challenge, noting that the national expectation was that trusts maintain 95% of their capacity during this period. It was noted that, in contrast to previous instances of industrial action, resident doctors were apparently less forthcoming in terms of whether they intended to participate in the industrial action. • The Trust continued to report one of the lowest Hospital Standardised Mortality Rates in England. • The Trust’s cancer performance, based on a BBC article, was 21 out of 121 trusts. It was noted that whilst the number of patients being referred on a cancer pathway had increased significantly, the number of patients diagnosed with cancer had not materially changed. • There appeared to have been an increase in the number of pressure ulcers and ‘red flag’ incidents. Work was ongoing to address the findings of the pressure ulcer audit which had been presented to the Quality Committee on 2 June 2025. • The number of patients having no criteria to reside and mental health patients remained high. Actions Andy Hyett agreed to clarify the basis of the calculation of the ‘Watch & Reserve antibiotics usage per 1,000 adms’ metric. 5.7 Break 5.8 Finance Report for Month 6 Ian Howard was invited to present the Finance Report for Month 6, the content of which was noted. It was further noted that: • The Trust had submitted its Financial Recovery Plan to NHS England in August 2025, which committed to an additional £23m improvement in the Trust’s financial position to deliver a full-year position of a £54.9m deficit. In the absence of these additional improvements, the Trust had been forecasting a year-end position of a £78m deficit. The revised target was subject to a number of assumptions, including the need for demand management and improvements in non-criteria to reside and mental health patient numbers. • There were a number of risks to the achievement of the Financial Recovery Plan, including whether there would be improvements in mental health and non-criteria to reside and/or steps taken to manage demand, high levels of activity, and whether it would be possible to reduce the workforce and close theatres. The need for the Trust to focus on achieving the 65-week wait target in particular could impact the Trust’s ability to close capacity. • The Trust had reported an in-month deficit of £5.4m (£30.8m year-to-date), which was in line with the trajectory set out in the Financial Recovery Plan. The Trust’s underlying deficit had seen some marginal improvement during the period. • The Trust’s cash position remains an area of significant concern. Cash requests had been made to NHS England, but the latest request for November 2025 had been rejected. It was therefore likely that the Trust would need to manage its supplier payments in accordance with its available cash. Page 5 5.9 ICS System Report for Month 6 Ian Howard was invited to present the ICS System Report for Month 6, the content of which was noted. It was further noted that: • The Hampshire and Isle of Wight Integrated Care System had reported a year- to-date deficit of £48m. • A significant improvement in the run-rate would be required for the system to be able to deliver its 2025/26 plan. • The system was one of the worst in England in terms of the number of beds occupied by patients having no criteria to reside with approximately 23% of beds being occupied by such patients compared with a national average of 12%. • The system was also below plan in terms of its targets for access to General Practitioners and targets relating to mental health patients. It was noted that the performance in these areas had a consequential impact on the Trust’s performance in areas such as urgent and emergency care performance. 5.10 People Report for Month 6 Steve Harris was invited to present the People Report for Month 6, the content of which was noted. It was further noted that: • The overall workforce fell by 73 whole-time-equivalents (WTE) during September 2025 and was reported as being 54 WTE above the Trust’s 2025/26 plan. The reduction in workforce had been driven through a combination of the impact of the recruitment controls, mutually agreed resignation scheme (MARS) leavers, and a significant drop in use of temporary staff during the month. • On 15 October 2025, the Trust had heard the collective grievance brought by the Royal College of Nursing in respect of the removal of enhanced NHS Professionals rates. It was decided not to reverse the decision in order to maintain equity with the rest of the workforce and consistency across other local providers. A number of actions had been agreed following the hearing. • Sickness rates had increased to 3.8%, although the Trust still benchmarked well against peers. • There were concerns about the potential impact of influenza during the winter period and therefore the Trust was taking a number of actions to promote vaccination of staff. The Trust was currently third in terms of uptake in the Region. • The level of participation in the national Staff Survey remained a challenge with only 32% of staff having completed the survey compared with a national average of 38%. It was considered likely that the recent difficult decisions taken and the impact on staff was impacting staff experience and engagement. • The People and Organisational Development Committee would be examining statutory and mandatory training levels together with the latest proposed national changes. Page 6 5.11 NHSE Audit and review of 'Developing Workforce Safeguards' including UHS Self-Assessment Return Natasha Watts was invited to present the NHS England audit and review of ‘Developing Workforce Safeguards’ (2018), including the Trust’s Self-Assessment Return, the content of which was noted. It was further noted that: • ‘Developing Workforce Safeguards’ was published in October 2018 and included a range of standards to assure safe staffing across the workforce. NHS England had initiated an audit, review and improvement plan amidst concern about a national reduction in compliance. • The Trust had submitted a self-assessment as part of this NHS England review. This assessment showed that the Trust continued to comply with the majority of the standards. • The audit exercise has been used as an opportunity to identify opportunities for improvement. Twelve recommendations have been developed, of which nine were assessed as ‘green’ and three as ‘amber’. 5.12 Guardian of Safe Working Hours Quarterly Report and Update on 10-Point Plan Diana Hulbert was invited to present the Guardian of Safe Working Hours Quarterly Report and Update on the 10-Point Plan, the content of which was noted. It was further noted that: • Resident doctors were due to strike for five days from 14 November 2025. This would be the thirteenth strike in recent years. It was noted that, in addition to pay, the dispute also concerned working conditions and the shortage of posts and consequent risk to resident doctors of unemployment. • The Trust had performed a self-assessment against the 10-Point Plan and it was noted that the majority of the plan’s contents had been considered by the Trust for some time. There were also a number of dependencies on the part of NHS England in areas such as lead employer models. • A national review of statutory and mandatory training was expected to enable portability of training records to facilitate staff moving between NHS organisations. • There had been significant improvements in respect of gaps in rotas. 5.13 Annual Clinical Outcomes Summary Luci Hood and Kate Pryde were invited to present the Annual Clinical Outcomes Summary Report, the content of which was noted. It was further noted that: • The paper provided an overview of the clinical outcomes reviewed by the Clinical Assurance Meeting for Effectiveness and Outcomes (CAMEO) over the 12-month period to September 2025. • The majority of specialities provide reports to CAMEO, although outcome data can be more difficult in some areas to capture than in others. • The outcomes reviewed by the CAMEO and outputs from this body were also influencing the development of the Trust’s clinical strategy. • The strains on the capacity of services posed a risk to clinical outcomes. Page 7 • There was potential that a ‘quality’ override could form part of the NHS Oversight Framework in the future, operating in a similar manner to the ‘financial’ override by limiting the segmentations available to an organisation. 6. STRATEGY and BUSINESS PLANNING 6.1 Corporate Objectives 2025-26 Quarter 2 Review Martin De Sousa was invited to present the review of Corporate Objectives 2025/26 for the second quarter, the content of which was noted. It was further noted that: • Of the 12 objectives agreed for 2025/26, six were rated ‘green’, four were ‘amber’ and two were ‘red’. • The ‘red’ rated risks were that relating to the Trust’s financial performance and that relating to the Trust’s achievement of its workforce plan for 2025/26. 6.2 Board Assurance Framework (BAF) Update Lauren Anderson was invited to present the Board Assurance Framework update, the content of which was noted. It was further noted that: • BDO had completed its audit of the Trust’s risk maturity and had presented its report to the Audit and Risk Committee on 13 October 2025. The audit had highlighted a number of strengths including the Board Assurance Framework, risk definition, and use of risk in decision-making. In terms of opportunities for improvement, the audit report suggested some improvements in articulation of operational risks and use of ‘SMART’ methodology for actions. • The Board Assurance Framework had been reviewed by relevant executive directors and committees since it was last presented to the Board. There had been no changes to the ratings or target dates. 7. CORPORATE GOVERNANCE, RISK and INTERNAL CONTROL 7.1 Feedback from the Council of Governors’ (COG) Meeting 28 October 2025 The Chair presented a summary of the Council of Governors’ meeting held on 28 October 2025. It was noted that the meeting had considered the following matters: • Chief Executive Officer’s Performance Report • Governor attendance at Council of Governors’ meetings • Review of the Council of Governors’ Expenses Reimbursement Protocol • Appointment of Jane Harwood as Deputy Chair with effect from 1 October 2025 • Membership engagement • Feedback from the Governors’ Nomination Committee It was noted that the Trust’s work on violence and aggression received particular attention from the Governors. 7.2 Register of Seals and Chair’s Action Report The paper ‘Register of Seals and Chair’s Actions Report’ was presented to the meeting, the content of which was noted. Page 8 It was further noted that one further item had been sealed on 7 November: Deed of Guarantee between University Hospital Southampton NHS Foundation Trust (Guarantor) and CHG-Meridian UK Limited (Beneficiary) regarding the payment and due performance obligations of UHS Estates Limited (UEL) under the Guaranteed Contract and specifically the Stryker Power Tools delivered to UEL under the pre-contract open build period with CHG. Seal number 307 on 7 November 2025. Decision: The Board agreed to ratify the application of the Trust Seal to the documents listed in the ‘Register of Seals and Chair’s Actions Report’ and to the additional document referred to above. 7.3 Health and Safety Services Annual Report 2024-25 Spencer Scott was invited to present the Health and Safety Services Annual Report 2024/25, the content of which was noted. It was further noted that: • The number of incidents reportable pursuant to the Reporting of Injuries, Diseases and Dangerous Occurrences Regulations (RIDDOR) had increased substantially to 68 such incidents compared to 39 in 2023/24. The majority of these incidents related to moving and handling or exposure to infectious diseases. • There was a concern that there had been a reduction in the number of health and safety related reports and escalations whilst at the same time the number of RIDDORs had increased. • Four areas of concern were highlighted: Entonox surveillance of maternity staff, display screen equipment compliance, the Southampton General Hospital loading bay, and workplace temperatures during the summer. 8. Any other business There was no other business. 9. Note the date of the next meeting: 13 January 2026 10. Items circulated to the Board for reading The item circulated to the Board for reading was noted. There being no further business, the meeting concluded. 11. Resolution regarding the Press, Public and Others Decision: The Board resolved that, as permitted by the National Health Service Act 2006 (as amended), the Trust’s Constitution and the Standing Orders of the board of directors, that representatives of the press, members of the public and others not invited to attend to the next part of the meeting be excluded due to the confidential nature of the business to be transacted. The meeting was adjourned. Page 9 List of action items Agenda item Assigned to Deadline Status Trust Board – Open Session 15/07/2025 - 5.11 Freedom to Speak Up Report 1267. Data Mbabazi, Christine 10/03/2026 Pending Explanation action item Christine Mbabazi to include data from other mechanisms for reporting concerns in future Freedom to Speak Up reports. Trust Board – Open Session 09/09/2025 - 8 Any other business 1286. Organ donation Machell, Craig 03/02/2026 Pending Explanation action item Craig Machell agreed to add organ donation to the agenda of a future Trust Board Study Session. Update: Scheduled for TBSS on 03/02/26. Trust Board – Open Session 11/11/2025 - 5.6 Performance KPI Report for Month 6 1293. MRI scanners and imaging Hyett, Andy 13/01/2026 Pending Explanation action item Andy Hyett agreed to work on and present at either a future Board meeting or Trust Board Study Session the Trust’s longer-term strategy with respect to MRI scanners and imaging. 1294. Cystopscopy/urology Hyett, Andy 13/01/2026 Pending Explanation action item Andy Hyett agreed to develop a longer-term plan for cystoscopy/urology and to report back to the Board during Quarter 4. Page 1 of 2 Agenda item Assigned to Deadline Status Trust Board – Open Session 11/11/2025 - 5.6 Performance KPI Report for Month 6 1295. Neurophysiology Hyett, Andy 13/01/2026 Pending Explanation action item Andy Hyett agreed to develop a long-term solution to the neurophysiology service. 1296. Watch & Reserve antibiotics usage Hyett, Andy 13/01/2026 Pending Explanation action item Andy Hyett agreed to clarify the basis of the calculation of the ‘Watch & Reserve antibiotics usage per 1,000 adms’ metric. Page 2 of 2 Agenda Item 5.1 i) Committee Chair’s Report to the Trust Board of Directors 13 January 2026 Committee: Finance, Investment and Cash Committee Meeting Date: 24 November 2025 Key Messages: Assurance: (Reports/Papers reviewed by the Committee also appearing on the Board agenda) Any Other Matters: • The committee received an update in respect of the Trust’s commercial activities, noting that the Trust had robust systems in place to maximise cost recovery for private patient and overseas visitor income. The Trust’s private patient unit project continued to progress. The Trust was also seeking a partner to manage its parking provision. • The committee received the Finance Report for Month 7. The Trust had reported a £5.1m in-month deficit (£35.9m year-to-date), which was in line with the trajectory contained in the Financial Recovery Plan. The underlying deficit remained flat at £6.4m. Whilst there had been a slight reduction in the number of mental health patients, there were c.240 patients having no criteria to reside at any point during the period. There was an increased level of scrutiny in respect of non-pay expenditure. • The committee reviewed an update on the Trust’s measures for financial improvement, noting that the Trust was forecasting achievement of £85-95m against its target of £110m Cost Improvement Programme delivery for 2025/26. • The committee noted the Trust’s approach and the timelines associated with the Medium Term Planning submission. It was noted that the framework set ambitious financial and performance targets. • The committee received an update in respect of the Trust’s Theatre Experience Programme, noting that there had been a 3% increase in utilisation and a 3% reduction in cancellations. • The committee reviewed the Trust’s productivity, noting that the Trust’s productivity had fallen by 3.3% compared to the prior year due to high-cost growth. • The committee received an update in respect of the Trust’s cash position and forecast and supported a proposal to request further cash support for January 2026. • The committee received an update on Capital Planning for 2026/272029/30. It was noted that it was expected that the Trust would be allocated c.£40m per annum, although there were concerns about the impact of the Trust’s cash position and the ability of the Trust to meet this level of expenditure. N/A N/A Page 1 of 2 Assurance Rating: Substantial There is a robust series of suitably designed internal controls in place upon Assurance which the organisation relies to manage the risk of failure of the continuous and effective achievement of the objectives of the process, which at the time of our review were being consistently applied. Reasonable There is a series of controls in place, however there are potential risks that Assurance may not be sufficient to ensure that the individual objectives of the process are achieved in a continuous and effective manner. Improvements are required to enhance the adequacy and effectiveness of the controls to mitigate these risks. Limited Assurance Controls in place are not sufficient to ensure that the organisation can rely upon them to manage the risks to the continuous and effective achievement of the objectives of the process. Significant improvements are required to improve the adequacy and effectiveness of the controls. No Assurance There is a fundamental breakdown or absence of core internal controls such that the organisation cannot rely upon them to manage the risks to the continuous and effective achievement of the objectives of the process. Immediate action is required to improve the adequacy and effectiveness of controls. Not Applicable Where assurance is not required and/or relevant. Risk Rating: Low Medium High Not Applicable Based on the report considered by the committee, there is little or no concern that the Trust will be unable to meet its stated objectives and/or plans. There is some concern that the Trust might not be able to fully meet its stated objectives and/or plans based on the information contained in the report considered by the committee. There is a significant risk that the Trust will not be able to meet its stated objectives and/or plans based on the information contained in the report considered by the committee. Where risk rating is not relevant. Page 2 of 2 Agenda Item 5.1 ii) Committee Chair’s Report to the Trust Board of Directors 13 January 2026 Committee: Finance, Investment and Cash Committee Meeting Date: 15 December 2025 Key Messages: • • • • • • The committee received the Finance Report for Month 8 (see below). The committee discussed the Trust’s future transformation programmes, noting that the areas of focus would be: urgent and emergency care, elective care, and automation of administrative processes. The committee was assured that the programmes were felt to be suitably ‘bold and ambitious’ and were grounded in realistic opportunities, rather than ‘blue sky’ ideas. The committee reviewed the draft capital plan for 2026/27 – 2029/30, noting that the Trust had been allocated c.£40m of capital departmental expenditure limit (CDEL) per year. It was noted that the Trust’s cash position could place constraints on the Trust’s capital programme. The opportunity to secure funding from national programmes outside of CDEL should be pursued vigorously. The plan was to be discussed in a Trust Board Study Session prior to submission in February 2026. The committee reviewed, challenged and discussed the Trust’s medium-term plan ahead of the first submission to NHS England on 17 December 2025. The committee provided feedback in respect of the proposed submission noting that some of the assumptions within the 2025/26 plan had not materialised with regard to matters such as reductions in non-criteria to reside numbers and the committee sought assurance that learnings had been applied to the development of the medium-term plan submission. The committee was assured that such assumed reductions within the 2026/27 plan were based purely on actions which were deemed to be within the Trust’s control. The committee suggested some changes with regard to the plan, particularly around growth assumptions in the cost base, and agreed to recommend the revised plan to the Board for approval. It was noted that more detail and reviews would be required prior to the final submission date in February 2026. The committee received an update in respect of the Trust’s cash position and supported a proposal to make a further request for cash support from NHS England for January 2026. The Trust reviewed and supported a proposal for transforming the Southern Counties Pathology network. Assurance: (Reports/Papers reviewed by the Committee also appearing on the Board agenda) 5.7 Finance Report for Month 8 Assurance Rating: Risk Rating: Substantial High • The Trust had reported an in-month deficit of £4.9m (£40m year-todate), which was consistent with the Trust’s Financial Recovery Plan. • November 2025 had been a challenging month due to costs associated with industrial action, patients with no criteria to reside and mental health patients. • The Trust had received c.£3m of income out of £6.1m for elective over-performance. • There had been a slight improvement in the Trust’s underlying deficit. Page 1 of 2 Any Other N/A Matters: Assurance Rating: Substantial There is a robust series of suitably designed internal controls in place upon Assurance which the organisation relies to manage the risk of failure of the continuous and effective achievement of the objectives of the process, which at the time of our review were being consistently applied. Reasonable There is a series of controls in place, however there are potential risks that Assurance may not be sufficient to ensure that the individual objectives of the process are achieved in a continuous and effective manner. Improvements are required to enhance the adequacy and effectiveness of the controls to mitigate these risks. Limited Assurance Controls in place are not sufficient to ensure that the organisation can rely upon them to manage the risks to the continuous and effective achievement of the objectives of the process. Significant improvements are required to improve the adequacy and effectiveness of the controls. No Assurance There is a fundamental breakdown or absence of core internal controls such that the organisation cannot rely upon them to manage the risks to the continuous and effective achievement of the objectives of the process. Immediate action is required to improve the adequacy and effectiveness of controls. Not Applicable Where assurance is not required and/or relevant. Risk Rating: Low Medium High Not Applicable Based on the report considered by the committee, there is little or no concern that the Trust will be unable to meet its stated objectives and/or plans. There is some concern that the Trust might not be able to fully meet its stated objectives and/or plans based on the information contained in the report considered by the committee. There is a significant risk that the Trust will not be able to meet its stated objectives and/or plans based on the information contained in the report considered by the committee. Where risk rating is not relevant. Page 2 of 2 Agenda Item 5.2 i) Committee Chair’s Report to the Trust Board of Directors 13 January 2026 Committee: People & Organisational Development Committee Meeting Date: 21 November 2025 Key Messages: • • • • The committee reviewed the People Report for Month 7 including progress against the workforce plan. During October 2025, the overall workforce grew by 14 whole-time-equivalents (WTE). Although the substantive workforce had reduced by 15 WTE, there had been lowerthan-expected turnover and increased temporary staffing usage due in part to high sickness levels. The Trust remained on track, however, with respect to its Financial Recovery Plan trajectory. There were concerns about the response rate to the Staff Survey, which was below the national average. The Trust’s vaccination campaign for staff had started well with the uptake rate for the flu vaccine amongst staff at 43%. The committee considered the outputs of the review by NHS England of statutory and mandatory training and the implications for UHS. It was noted that a revised framework would facilitate passporting of training between NHS organisations. The Trust was aligned to the Core Skills Training Framework across six out of eleven areas and ten out of eleven areas for the Utilising E-Learning for Health material. The committee received an update in respect of the Trust’s Inclusion and Belonging strategy. It was noted that resource constraints and the impact of the current financial and operational environment on staff morale had impacted progress towards achievement of the objectives set out in the strategy. The committee reviewed the People risks contained within the Trust’s Board Assurance Framework. Assurance: N/A (Reports/Papers reviewed by the Committee also appearing on the Board agenda) Any Other N/A Matters: Assurance Rating: Substantial There is a robust series of suitably designed internal controls in place upon Assurance which the organisation relies to manage the risk of failure of the continuous and effective achievement of the objectives of the process, which at the time of our review were being consistently applied. Reasonable There is a series of controls in place, however there are potential risks that Assurance may not be sufficient to ensure that the individual objectives of the process are achieved in a continuous and effective manner. Improvements are required to enhance the adequacy and effectiveness of the controls to mitigate these risks. Limited Assurance Controls in place are not sufficient to ensure that the organisation can rely upon them to manage the risks to the continuous and effective achievement of the objectives of the process. Significant improvements are required to improve the adequacy and effectiveness of the controls. Page 1 of 2 No Assurance Not Applicable Risk Rating: Low Medium High Not Applicable There is a fundamental breakdown or absence of core internal controls such that the organisation cannot rely upon them to manage the risks to the continuous and effective achievement of the objectives of the process. Immediate action is required to improve the adequacy and effectiveness of controls. Where assurance is not required and/or relevant. Based on the report considered by the committee, there is little or no concern that the Trust will be unable to meet its stated objectives and/or plans. There is some concern that the Trust might not be able to fully meet its stated objectives and/or plans based on the information contained in the report considered by the committee. There is a significant risk that the Trust will not be able to meet its stated objectives and/or plans based on the information contained in the report considered by the committee. Where risk rating is not relevant. Page 2 of 2 Agenda Item 5.2 ii) Committee Chair’s Report to the Trust Board of Directors 13 January 2026 Committee: People & Organisational Development Committee Meeting Date: 15 December 2025 Key Messages: Assurance: (Reports/Papers reviewed by the Committee also appearing on the Board agenda) • The committee reviewed the People Report for Month 8 (see below) including progress against the workforce plan and Financial Recovery Plan. • The committee considered the workforce implications of the Trust’s medium term plan submission, noting that there were a number of national expectations and targets, such as those relating to sickness rates and elimination of agency spend. In addition, the committee noted the risks associated with the plan, including those where the Trust was reliant on progress with respect to non-criteria to reside and mental health numbers. • The committee received an update regarding the Trust’s Violence and Aggression workstream, noting that the Trust had adopted a revised approach to violence, aggression and abuse directed at staff with a greater willingness to take action against violent/abusive patients and members of the public. A violence and aggression board had been established to provide executive oversight and leadership, and the Trust’s policy was being revised. This work would be accompanied by a comprehensive communication plan for both staff and members of the public. • The committee reviewed the Trust’s progress against its objectives for Year 4 of its People Strategy. 5.9 People Report for Month 8 Assurance Rating: Risk Rating: Substantial High • The overall workforce fell during November 2025, with substantive numbers falling by 52 whole-time-equivalents (WTE). However, temporary staffing use had increased during the month due to increased sickness and operational pressures, which offset much of the reduction in substantive numbers. • The Trust was over its original plan by 214 WTE despite a decrease of nearly 400 WTE since 31 March 2025. In order to hit the Trust’s Financial Recovery Plan target, the overall workforce would need to fall by a further 137 WTE (including a 72 WTE reduction in temporary staffing) by the end of March 2026. • A forecast based on the previous year’s temporary staffing usage for the remaining months of the year indicated that the Trust would end the year approximately 500 WTE above the Trust’s 2025/26 plan. • The Trust had submitted a baseline assessment against the 10 Point Plan to improve Resident Doctors’ working lives in August 2025, which indicated that the Trust compared favourably against other organisations in the South East. The main issues concerned space available for doctors to work in and timeliness of reimbursement of course-related expenses. • The Trust was expected to meet a target of 95% of job plans having been signed off prior to 31 March 2026. At the start of December 2025, 55% of job plans had been signed off. Page 1 of 2 Any Other Matters: • Sickness absence had increased in November 2025 to 4.2% in month due to seasonal illnesses. • The staff survey closed on 28 November 2025. The completion rate for the staff survey had been lower t
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