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Title:Research & Development Governance and Performance Report 2025-26
Status:For Information
History:Annual reporting
Board Lead:Chief Medical Officer
Lead Authors:Dr Chris Bray, OUH Head of R&D Operations\\nProfessor Adrian Banning, OUH Director of R&D
Confidential:No
Key Purpose:Performance
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"cell_header_index": 1, "rowspan": 1, "colspan": 1, "column_header": false, "row_header": false, "placeholder": false, "ref": "#/tables/0" } ], "ref": "#/tables/0" }, { "row_index": 8, "location": [ 67.1865, 226.32, 527.4137, 266.88 ], "cells": [ { "location": [ 67.1865, 226.32, 297.3001, 266.88 ], "text": "Key Purpose:", "html_text": "Key Purpose:", "links": [], "cell_header_index": 0, "rowspan": 1, "colspan": 1, "column_header": false, "row_header": false, "placeholder": false, "ref": "#/tables/0" }, { "location": [ 297.3001, 226.32, 527.4137, 266.88 ], "text": "Performance", "html_text": "Performance", "links": [], "cell_header_index": 1, "rowspan": 1, "colspan": 1, "column_header": false, "row_header": false, "placeholder": false, "ref": "#/tables/0" } ], "ref": "#/tables/0" } ], "n_rows": 9, "n_cols": 2, "ref": "#/tables/0", "reading_order": 2 } ] }, { "page": 2, "items": [ { "page": 2, "type": "TITLE", "location": { "l": 77.9843, "t": 769.44, "r": 206.8383, "b": 753.84 }, "text": "Executive Summary", "reading_order": 0, "level": 3 }, { "page": 2, "type": "LIST_ITEM", "location": { "l": 60.2279, "t": 746.88, "r": 523.5745, "b": 683.28 }, "text": "OUH remains one of England's most research-active NHS Trusts, currently hosting 1,667 active studies, 84% (1402) of which are on the NIHR portfolio. Of these, 497 studies currently actively recruiting recruited 10,103 participants, ranking OUH third nationally.", "marker": "1.", "list_id": "L1", "level": 0, "reading_order": 1 }, { "page": 2, "type": "LIST_ITEM", "location": { "l": 59.0281, "t": 677.28, "r": 517.5757, "b": 613.92 }, "text": "Performance against site set-up time metrics for research are substantially below the new levels that are required nationally: OUH met the 90-day metric for commercial interventional trials for 37% of relevant studies in H2 2025-26, ranking 6th of 10 Shelford Trusts and 43rd of 73 English Trusts.", "marker": "2.", "list_id": "L1", "level": 0, "reading_order": 2 }, { "page": 2, "type": "LIST_ITEM", "location": { "l": 59.508, "t": 607.44, "r": 517.8156, "b": 496.08 }, "text": "Urgent improvement work is underway to accelerate study set-up times and participant recruitment, including improved reporting, a renewed focus on the research timing metrics, review of prioritisation, R&D restructuring, reduced duplication of work with University partners, and work with Finance, Pharmacy, Radiology and other support services. Failure to improve performance will reduce research income (commercial and non-commercial) and opportunities for OUH patients to benefit from research participation.", "marker": "3.", "list_id": "L1", "level": 0, "reading_order": 3 }, { "page": 2, "type": "LIST_ITEM", "location": { "l": 58.5482, "t": 490.8, "r": 525.974, "b": 427.2 }, "text": "Research governance has been strengthened through the establishment of the R&D Committee and 14 Research Delivery Groups that provide clearer oversight of research governance, performance, delivery, compliance and alignment with Trust objectives.", "marker": "4.", "list_id": "L1", "level": 0, "reading_order": 4 }, { "page": 2, "type": "LIST_ITEM", "location": { "l": 59.0281, "t": 421.44, "r": 519.7352, "b": 357.84 }, "text": "The NIHR Oxford BRC and NIHR Oxford CRF remain major strategic assets. In 2025-26, the BRC supported 311 active OUH-hosted studies, while the CRF supported more than 43 studies, including 30 commercially sponsored studies and OUH's first non-oncology CAR-T study.", "marker": "5.", "list_id": "L1", "level": 0, "reading_order": 5 }, { "page": 2, "type": "LIST_ITEM", "location": { "l": 59.748, "t": 352.08, "r": 513.7364, "b": 304.08 }, "text": "R&D finances are within forecast, with a £45m 2025-26 budget, major NIHR programmes at breakeven and individual study income exceeding expenditure by £2.6m; the 2026-27 budget is £52m.", "marker": "6.", "list_id": "L1", "level": 0, "reading_order": 6 }, { "page": 2, "type": "LIST_ITEM", "location": { "l": 60.2279, "t": 298.08, "r": 512.7766, "b": 235.2 }, "text": "The research delivery workforce comprises more than 370 staff across 38 teams, with complex OUH/University employment and reporting arrangements. Reduced RDN funding for research delivery staffing has prompted a review and plans to develop a more uniform and more resilient workforce model.", "marker": "7.", "list_id": "L1", "level": 0, "reading_order": 7 }, { "page": 2, "type": "LIST_ITEM", "location": { "l": 59.508, "t": 228.72, "r": 513.4965, "b": 181.2 }, "text": "This paper was presented and discussed at TME on 9 July 2026; no questions or concerns were raised by TME members; and TME were content for the paper to proceed to Board.", "marker": "8.", "list_id": "L1", "level": 0, "reading_order": 8 }, { "page": 2, "type": "TITLE", "location": { "l": 78.2242, "t": 174.96, "r": 183.563, "b": 160.32 }, "text": "Recommendation", "reading_order": 9, "level": 3 }, { "page": 2, "type": "LIST_ITEM", "location": { "l": 59.0281, "t": 153.36, "r": 411.2771, "b": 138 }, "text": "9. The Trust Board is asked to receive this report for information.", "marker": "9.", "list_id": "L2", "level": 0, "reading_order": 10 } ] }, { "page": 3, "items": [ { "page": 3, "type": "TITLE", "location": { "l": 42.7114, "t": 800.4, "r": 252.909, "b": 784.8 }, "text": "Oxford University Hospitals NHS FT", "reading_order": 0, "level": 3 }, { "page": 3, "type": "TITLE", "location": { "l": 70.0659, "t": 770.64, "r": 118.0562, "b": 756.48 }, "text": "Contents", "reading_order": 1, "level": 3 }, { "page": 3, "type": "LIST_ITEM", "location": { "l": 83.9996, "t": 695.2231, "r": 522.7936, "b": 681.8168 }, "text": "Introduction ................................................................................................... 4", "marker": "1.", "list_id": "L3", "level": 0, "reading_order": 2 }, { "page": 3, "type": "LIST_ITEM", "location": { "l": 83.9997, "t": 679.5032, "r": 522.7934, "b": 666.0969 }, "text": "Structure and Organisation ........................................................................... 5", "marker": "2.", "list_id": "L3", "level": 0, "reading_order": 3 }, { "page": 3, "type": "LIST_ITEM", "location": { "l": 83.9995, "t": 663.6634, "r": 522.7934, "b": 650.2572 }, "text": "Clinical Research Activity .............................................................................. 7", "marker": "3.", "list_id": "L3", "level": 0, "reading_order": 4 }, { "page": 3, "type": "LIST_ITEM", "location": { "l": 83.9995, "t": 647.7032, "r": 522.9131, "b": 634.2969 }, "text": "Clinical Research Performance ................................................................... 12", "marker": "4.", "list_id": "L3", "level": 0, "reading_order": 5 }, { "page": 3, "type": "LIST_ITEM", "location": { "l": 83.9992, "t": 631.8634, "r": 522.9126, "b": 618.4572 }, "text": "Initiatives to improve site set-up and recruitment performance ................... 18", "marker": "5.", "list_id": "L3", "level": 0, "reading_order": 6 }, { "page": 3, "type": "LIST_ITEM", "location": { "l": 83.9987, "t": 616.0232, "r": 522.9125, "b": 602.617 }, "text": "Clinical Research Delivery Workforce ......................................................... 20", "marker": "6.", "list_id": "L3", "level": 0, "reading_order": 7 }, { "page": 3, "type": "LIST_ITEM", "location": { "l": 83.9986, "t": 600.1834, "r": 522.9125, "b": 586.7772 }, "text": "NIHR Oxford Biomedical Research Centre (Oxford BRC) .......................... 23", "marker": "7.", "list_id": "L3", "level": 0, "reading_order": 8 }, { "page": 3, "type": "LIST_ITEM", "location": { "l": 83.9986, "t": 584.2232, "r": 522.9123, "b": 570.817 }, "text": "NIHR Oxford Clinical Research Facility (Oxford CRF) ................................ 24", "marker": "8.", "list_id": "L3", "level": 0, "reading_order": 9 }, { "page": 3, "type": "LIST_ITEM", "location": { "l": 83.9984, "t": 568.3834, "r": 522.9122, "b": 554.9772 }, "text": "Research Governance ................................................................................ 25", "marker": "9.", "list_id": "L3", "level": 0, "reading_order": 10 }, { "page": 3, "type": "LIST_ITEM", "location": { "l": 83.9983, "t": 552.5432, "r": 522.9121, "b": 539.137 }, "text": "R&D Finance ............................................................................................... 25", "marker": "10.", "list_id": "L3", "level": 0, "reading_order": 11 }, { "page": 3, "type": "LIST_ITEM", "location": { "l": 83.9982, "t": 536.7034, "r": 522.9123, "b": 523.2972 }, "text": "Research Contracts and IP ......................................................................... 27", "marker": "11.", "list_id": "L3", "level": 0, "reading_order": 12 }, { "page": 3, "type": "LIST_ITEM", "location": { "l": 83.9984, "t": 520.7432, "r": 522.912, "b": 507.337 }, "text": "Acknowledgements ..................................................................................... 27", "marker": "12.", "list_id": "L3", "level": 0, "reading_order": 13 }, { "page": 3, "type": "LIST_ITEM", "location": { "l": 83.9981, "t": 504.9034, "r": 522.9122, "b": 491.4972 }, "text": "Recommendation ........................................................................................ 28", "marker": "13.", "list_id": "L3", "level": 0, "reading_order": 14 }, { "page": 3, "type": "LIST_ITEM", "location": { "l": 83.9982, "t": 461.1034, "r": 522.9119, "b": 447.6972 }, "text": "Research activity by OUH Division .............................................................. 29", "marker": "14.", "list_id": "L3", "level": 0, "reading_order": 15 }, { "page": 3, "type": "LIST_ITEM", "location": { "l": 83.998, "t": 445.2632, "r": 522.9118, "b": 431.8569 }, "text": "Clinical Research Delivery Workforce ......................................................... 30", "marker": "15.", "list_id": "L3", "level": 0, "reading_order": 16 }, { "page": 3, "type": "LIST_ITEM", "location": { "l": 83.9979, "t": 429.4234, "r": 522.9117, "b": 416.0171 }, "text": "Study impact ............................................................................................... 31", "marker": "16.", "list_id": "L3", "level": 0, "reading_order": 17 }, { "page": 3, "type": "LIST_ITEM", "location": { "l": 83.9978, "t": 413.5836, "r": 522.9117, "b": 400.1773 }, "text": "Research Governance ................................................................................ 32", "marker": "17.", "list_id": "L3", "level": 0, "reading_order": 18 }, { "page": 3, "type": "LIST_ITEM", "location": { "l": 83.9978, "t": 397.7434, "r": 522.9119, "b": 384.3371 }, "text": "Research Contracts and IP ......................................................................... 38", "marker": "18.", "list_id": "L3", "level": 0, "reading_order": 19 } ] }, { "page": 4, "items": [ { "page": 4, "type": "TITLE", "location": { "l": 33.3533, "t": 769.92, "r": 495.98, "b": 753.84 }, "text": "Research & Development Governance and Performance Report 2025-26", "reading_order": 0, "level": 3 }, { "page": 4, "type": "TITLE", "location": { "l": 69.8259, "t": 726.96, "r": 167.7262, "b": 711.84 }, "text": "1. Introduction", "reading_order": 1, "level": 3 }, { "page": 4, "type": "TEXT", "location": { "l": 112.0574, "t": 703.92, "r": 514.6963, "b": 656.88 }, "text": "1.1. This paper was presented and discussed at TME on 9 July 2026; no questions or concerns were raised by TME members; and TME were content for the paper to proceed to Board.", "reading_order": 2 }, { "page": 4, "type": "TEXT", "location": { "l": 112.0574, "t": 650.16, "r": 523.3345, "b": 618.96 }, "text": "1.2. Oxford University Hospitals NHS Foundation Trust (OUH) is one of the most research-active university hospital trusts nationally.", "reading_order": 3 }, { "page": 4, "type": "TEXT", "location": { "l": 112.5373, "t": 612.48, "r": 524.7742, "b": 470.4 }, "text": "1.3. The Care Quality Commission (CQC includes research in its well-led inspection framework as research-active healthcare organizations tend to deliver better patient outcomes and higher-quality care. This is also recognised by professional bodies such as the Royal College of Physicians, biomedical charities like the Wellcome Trust and NHS England. The importance of commercial clinical trials to the UK economy, the NHS and the UK's research and development base is presented in a recent report for the Association of the British Pharmaceutical Industry (ABPI).", "reading_order": 4 }, { "page": 4, "type": "TEXT", "location": { "l": 112.5373, "t": 463.92, "r": 520.4551, "b": 161.52 }, "text": "1.4. Recent UK government policy on NHS clinical research has focused on improving speed, scale and commercial attractiveness, beginning with the landmark O'Shaughnessy Review in 2023. The government's response to this review set out reforms to streamline approvals, reduce duplication and rebuild UK competitiveness. These have been translated into delivery commitments in 2025–26, notably through the Life Sciences Sector Plan and the 10 Year Health Plan for England, which position the NHS as a driver of economic growth and require research to be embedded as a core function. A central operational target is the 150-day clinical trial set-up metric supported by a detailed DHSC policy statement (October 2025) defining staged timelines and expectations for both study-level and site-level performance. This is reinforced through national oversight and incentives, including joint DHSC/NHSE communications requiring board-level accountability, alignment with national processes and adherence to standardised pathways to eliminate duplication and improve delivery. These policies establish a coherent national framework linking regulatory reform, system alignment and performance metrics to funding, reputation and the UK's global competitiveness in clinical research.", "reading_order": 5 }, { "page": 4, "type": "TEXT", "location": { "l": 112.0574, "t": 155.04, "r": 515.4161, "b": 92.4 }, "text": "1.5. Research is included in OUH's strategy for 2020-25 )and current strategy refresh), along with the related activities of education and innovation, in the World-Class Impact strategic theme, through which OUH can continue its global impact in improving health and care.", "reading_order": 6 } ] }, { "page": 5, "items": [ { "page": 5, "type": "TITLE", "location": { "l": 112.7773, "t": 769.68, "r": 487.5817, "b": 739.2 }, "text": "1.6. Research also features prominently in OUH's NMAHPs strategy (2021-26) and in Our Clinical Strategy (2023-28).", "reading_order": 0, "level": 2 }, { "page": 5, "type": "TITLE", "location": { "l": 68.6262, "t": 713.76, "r": 259.6277, "b": 698.64 }, "text": "2. Structure and Organisation", "reading_order": 1, "level": 3 }, { "page": 5, "type": "TEXT", "location": { "l": 111.0976, "t": 690.48, "r": 508.2176, "b": 659.76 }, "text": "2.1. An organogram summarising the structure and organisation of OUH Research and Development (R&D) is shown below (Figure 1).", "reading_order": 2 }, { "page": 5, "type": "FIGURE", "location": { "l": 155.9686, "t": 645.6, "r": 506.2979, "b": 411.36 }, "text": "", "reading_order": 3 }, { "page": 5, "type": "TITLE", "location": { "l": 112.2974, "t": 376.8, "r": 292.9809, "b": 361.68 }, "text": "Figure 1. OUH R&D Organogram", "reading_order": 4, "level": 3 }, { "page": 5, "type": "TEXT", "location": { "l": 111.0976, "t": 354.96, "r": 506.5379, "b": 308.88 }, "text": "2.2. In addition to this annual report to the Trust Board, R&D provides reports quarterly to the Joint R&D Committee (JRDC) and the Trust Management Executive (TME).", "reading_order": 5 }, { "page": 5, "type": "TEXT", "location": { "l": 111.0976, "t": 301.92, "r": 469.5853, "b": 270.24 }, "text": "2.3. The JRDC was established in 2011 under the Joint Working Agreement between OUH and the University of Oxford (OU).", "reading_order": 6 }, { "page": 5, "type": "TEXT", "location": { "l": 111.0976, "t": 264, "r": 525.4941, "b": 201.12 }, "text": "2.4. The OUH R&D teams are part of the Joint Research Office (JRO), a partnership with the University of Oxford, Oxford Health NHS Foundation Trust and Oxford Brookes University. The JRO is overseen by the JRDC.", "reading_order": 7 }, { "page": 5, "type": "TEXT", "location": { "l": 110.6177, "t": 194.64, "r": 513.2565, "b": 99.36 }, "text": "2.5. The potential to further integrate and strengthen the JRO has been recognised by both OUH and the Oxford Academic Health Partners (OAHP), which has as one of its short-term goals to “create an integrated Oxford Joint Research Office across all OAHP partners to promote operational collaboration”. The necessity to improve study set-up speed at OUH has given this work added impetus and a", "reading_order": 8 } ] }, { "page": 6, "items": [ { "page": 6, "type": "TEXT", "location": { "l": 143.4911, "t": 769.68, "r": 485.1822, "b": 739.44 }, "text": "transformation project was formally initiated in March 2026 (see Section 5.11).", "reading_order": 0 }, { "page": 6, "type": "TITLE", "location": { "l": 68.6262, "t": 728.4, "r": 419.4355, "b": 713.28 }, "text": "NMAHPs (Nurses, Midwives and Allied Health Professionals)", "reading_order": 1, "level": 3 }, { "page": 6, "type": "TEXT", "location": { "l": 110.3778, "t": 706.32, "r": 512.0568, "b": 612.24 }, "text": "2.6. Increasing the number of NMAHPs leading studies as Chief Investigators (CIs) and Principal Investigators (PIs) is a key National Institute of Health and Care Research (NIHR) priority. Following significant growth at OUH between 2023-24 and 2024-25, this plateaued in 2025-26. (Table 1). Many NMAHPs are both the CI and the OUH PI for the same study.", "reading_order": 2 }, { "page": 6, "type": "TEXT", "location": { "l": 70.0659, "t": 605.28, "r": 382.9628, "b": 590.16 }, "text": "Table 1. Numbers of NMAHP CIs and PIs, and studies led", "reading_order": 3 }, { "page": 6, "type": "TABLE", "location": { "l": 72.2254, "t": 583.2, "r": 525.4941, "b": 481.68 }, "text": "
2023-242024-252025-26
8 CIs leading 24 studies28 CIs leading 50 studies30 CIs leading on 45 studies
41 PIs leading 56 studies38 PIs leading 47 studies39 PIs leading on 54 studies
49 CIs or PIs leading 80 studies65 CIs or PIs leading 97 studies53 CIs or PIs leading on 71 studies
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NMAHPPS Professional groupCIsPIs
Clinical psychologist65
Dietician12
Health care scientist (physical sciences and clinical engineering)21
Health care scientist (physiological sciences)21
Midwife01
Nurse27
Occupational therapist01
Other83
Pharmacist01
Physiotherapist812
Radiographer03
Speech and language therapist12
Grand Total3039
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Senior OUH NMAHPs are being supported to undertake the NIHR-AoMRC Clinician Researcher Credentialing Framework.1", "reading_order": 0 }, { "page": 7, "type": "TEXT", "location": { "l": 109.8978, "t": 732.48, "r": 525.4941, "b": 636.96 }, "text": "2.9. Research Capacity and Capability development in the Trust is supported by four Divisional Research leads who are externally funded through an academic appointment, either Oxford Brookes or Oxford University, the NIHR Biomedical Research Centre (BRC) and/or R&D income. The return on these investments is in excess of £2,500,000 in the 18 months since the appointments.", "reading_order": 1 }, { "page": 7, "type": "TITLE", "location": { "l": 68.1463, "t": 612.72, "r": 251.4693, "b": 596.88 }, "text": "3. Clinical Research Activity", "reading_order": 2, "level": 3 }, { "page": 7, "type": "TEXT", "location": { "l": 110.3778, "t": 589.44, "r": 526.2139, "b": 447.6 }, "text": "3.1. A total of 1667 OUH-hosted clinical research studies were active (i.e. open to recruitment, recruiting or in follow-up) during 2025-26. This is a small increase (1%) compared to 2024-25 (1647). 84% (1402) of these active studies were on the NIHR portfolio2 (the same as last year), 497 of which reported recruitment in 2025-26, the third highest of all NHS Trusts in England, recruiting a total of 10,103 participants. The number of portfolio studies currently open to recruitment or recruiting was 745; the other 657 had completed recruitment and were in the follow-up phase.", "reading_order": 3 }, { "page": 7, "type": "TEXT", "location": { "l": 109.8978, "t": 441.12, "r": 525.4941, "b": 409.92 }, "text": "3.2. Examples of recent high-impact research studies supported by the Oxford BRC are included in the Appendix.", "reading_order": 4 }, { "page": 7, "type": "TITLE", "location": { "l": 68.8661, "t": 403.2, "r": 384.4025, "b": 388.32 }, "text": "Hosted and sponsored active clinical research studies", "reading_order": 5, "level": 3 }, { "page": 7, "type": "TEXT", "location": { "l": 110.6177, "t": 381.6, "r": 524.7742, "b": 302.4 }, "text": "3.3. The number of studies that are Hosted (i.e. OUH is the NHS organisation providing the clinical environment, capabilities and patient care) and Sponsored (i.e. OUH takes legal responsibility for the conduct of the study, as well as hosting it) by the Trust are shown in Table 3.", "reading_order": 6 }, { "page": 7, "type": "TEXT", "location": { "l": 68.6262, "t": 147.84, "r": 523.8144, "b": 75.84 }, "text": "1 This has been developed jointly by the NIHR, working with the Academy of Medical Royal Colleges, led by the Royal College of Physicians, and four higher education institutions. It is aimed at experienced healthcare practitioners from all professional backgrounds who aspire to take on leadership roles in clinical research delivery, such as Co-Investigator or Principal Investigator.2 Portfolio studies meet specific criteria set by the NIHR and are eligible for financial and other support provided or funded by the Research Delivery Network (RDN)", "reading_order": 7 } ] }, { "page": 8, "items": [ { "page": 8, "type": "TEXT", "location": { "l": 69.1061, "t": 769.68, "r": 442.4708, "b": 755.52 }, "text": "Table 3. Breakdown of hosted and sponsored active research studies", "reading_order": 0 }, { "page": 8, "type": "TABLE", "location": { "l": 84.223, "t": 746.4, "r": 510.3771, "b": 574.56 }, "text": "
Study typeHostedSponsoredTotal
InterventionalClinical trial of an investigational medicinal product (CTIMP)614 (99.5%)3 (0.5%)617
Clinical investigation or other study of a medical device65 (92%)6 (8%)71
Other clinical trial218 (96%)8 (4%)226
Sub-total897 (98%)17 (2%)914
Non-interventionalOther study696 (92%)57 (8%)753
Total1593 (96%)84 (4%)1667
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The vast majority (96%) of OUH active clinical research studies are hosted for external Sponsors, of which the University of Oxford is the largest, responsible for 415 (25% of the total). 897/1667 (54%) of OUH active research studies are interventional.", "reading_order": 2 }, { "page": 8, "type": "TEXT", "location": { "l": 110.8577, "t": 499.2, "r": 504.1384, "b": 468.24 }, "text": "3.5. A breakdown of OUH active research by Division is available in the Appendix.", "reading_order": 3 }, { "page": 8, "type": "TITLE", "location": { "l": 69.586, "t": 461.52, "r": 249.3097, "b": 445.68 }, "text": "Participants Recruited (trends)", "reading_order": 4, "level": 3 }, { "page": 8, "type": "TEXT", "location": { "l": 110.6177, "t": 439.44, "r": 485.6621, "b": 407.76 }, "text": "3.6. Figure 2 shows the number of participants recruited to research studies each quarter over the last 3 years.", "reading_order": 5 }, { "page": 8, "type": "FIGURE", "location": { "l": 74.1451, "t": 378.72, "r": 521.1749, "b": 180.72 }, "text": "", "reading_order": 6 } ] }, { "page": 9, "items": [ { "page": 9, "type": "FIGURE", "location": { "l": 72.7053, "t": 768, "r": 521.8948, "b": 570 }, "text": "", "reading_order": 0 }, { "page": 9, "type": "TEXT", "location": { "l": 70.3058, "t": 559.68, "r": 224.1148, "b": 547.2 }, "text": "Data sourced from Studyline 16-May-2026", "reading_order": 1 }, { "page": 9, "type": "TITLE", "location": { "l": 69.586, "t": 541.2, "r": 298.9797, "b": 525.6 }, "text": "Figure 2. Participants recruited, by quarter", "reading_order": 2, "level": 3 }, { "page": 9, "type": "TEXT", "location": { "l": 111.3376, "t": 519.12, "r": 505.5781, "b": 456.96 }, "text": "3.7. Recruitment to commercial studies decreased by 32% compared to 2024-25 and there was a greater reduction (37%) in recruitment to non-commercial studies. Overall recruitment in 2025-26 was 37% lower than in 2024-25.", "reading_order": 3 }, { "page": 9, "type": "TEXT", "location": { "l": 111.8175, "t": 449.52, "r": 523.3345, "b": 355.2 }, "text": "3.8. Recruitment is affected by multiple factors. These include the number of studies open to recruitment, how quickly they were opened to recruitment (especially for multicentre commercial trials with competitive recruitment models), their recruitment targets, and the number of eligible patients who are approached by the study team and who consent to participate.", "reading_order": 4 }, { "page": 9, "type": "TEXT", "location": { "l": 111.0976, "t": 348.48, "r": 504.3783, "b": 285.84 }, "text": "3.9. It should be noted that based on previous reporting, measured recruitment during the last quarter is likely to underestimate true recruitment by ~16% because of lag times in study teams reporting recruitment to OUH.", "reading_order": 5 } ] }, { "page": 10, "items": [ { "page": 10, "type": "TITLE", "location": { "l": 69.8259, "t": 769.68, "r": 233.7129, "b": 755.52 }, "text": "Studies open to recruitment", "reading_order": 0, "level": 3 }, { "page": 10, "type": "TEXT", "location": { "l": 111.8175, "t": 747.6, "r": 519.7352, "b": 717.12 }, "text": "3.10. Figure 3 shows the trend in the number of studies open to recruitment each quarter.", "reading_order": 1 }, { "page": 10, "type": "FIGURE", "location": { "l": 73.6652, "t": 711.6, "r": 522.8546, "b": 303.84 }, "text": "", "reading_order": 2 }, { "page": 10, "type": "TEXT", "location": { "l": 70.0659, "t": 294.48, "r": 224.3548, "b": 281.76 }, "text": "Data sourced from Studyline 16-May-2025", "reading_order": 3 }, { "page": 10, "type": "TEXT", "location": { "l": 69.346, "t": 276.24, "r": 332.8129, "b": 260.64 }, "text": "Figure 3. Studies open to recruitment, by quarter", "reading_order": 4 } ] }, { "page": 11, "items": [ { "page": 11, "type": "TITLE", "location": { "l": 69.8259, "t": 769.44, "r": 315.0565, "b": 755.52 }, "text": "New studies approved to start recruitment", "reading_order": 0, "level": 3 }, { "page": 11, "type": "TITLE", "location": { "l": 111.8175, "t": 747.36, "r": 472.7047, "b": 716.64 }, "text": "3.11. Figure 4 below shows the trend in the number of new studies approved to start recruitment at OUH each quarter.", "reading_order": 1, "level": 2 }, { "page": 11, "type": "FIGURE", "location": { "l": 73.1852, "t": 711.6, "r": 522.6147, "b": 296.64 }, "text": "", "reading_order": 2 }, { "page": 11, "type": "TEXT", "location": { "l": 69.8259, "t": 284.16, "r": 224.3548, "b": 272.64 }, "text": "Data sourced from Studyline 16-May-2025", "reading_order": 3 }, { "page": 11, "type": "TITLE", "location": { "l": 69.586, "t": 266.16, "r": 398.3197, "b": 251.52 }, "text": "Figure 4. New studies opened to start recruitment, by quarter", "reading_order": 4, "level": 3 }, { "page": 11, "type": "TEXT", "location": { "l": 111.5775, "t": 244.32, "r": 525.0142, "b": 101.76 }, "text": "3.12. OUH is a recruiting site for 267/313 (85%) of the studies approved to start recruitment in 2025-26. For a further 4%, OUH was a Participant Identification Centre (PIC), identifying potential research participants to be recruited at a separate research site. For an additional 5% OUH was a service site, providing services such as laboratory analysis or imaging for studies recruiting outside of OUH, including University of Oxford healthy volunteer vaccine studies. Over time, in line with Government ‘shift’ for the NHS to move from hospital-centric care to integrated, community-based care, a greater proportion of research", "reading_order": 5 } ] }, { "page": 12, "items": [ { "page": 12, "type": "TEXT", "location": { "l": 143.731, "t": 769.68, "r": 517.0958, "b": 738.72 }, "text": "studies will be taking place outside of acute Trusts, which is expected to increase demand for OUH to provide services to these studies.", "reading_order": 0 }, { "page": 12, "type": "TEXT", "location": { "l": 69.586, "t": 710.4, "r": 285.5424, "b": 695.28 }, "text": "Table 4. Summary of activity in 2025-26", "reading_order": 1 }, { "page": 12, "type": "TABLE", "location": { "l": 98.6201, "t": 689.28, "r": 496.22, "b": 555.6 }, "text": "
Participants recruitedStudies open to recruitmentNew studies approved to recruit
Commercial856 (6%)209 (22%)110 (35%)
Non-Commercial12683 (94%)753 (78%)203 (65%)
Interventional5133 (38%)434 (45%)172 (55%)
Non-interventional8406 (62%)528 (55%)141 (45%)
NIHR portfolio10103 (75%)751 (78%)254 (81%)
Non-portfolio3436 (25%)211 (22%)59 (19%)
Totals13539962313
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655.86 ], "text": "753 (78%)", "html_text": "753 (78%)", "links": [], "cell_header_index": 2, "rowspan": 1, "colspan": 1, "column_header": false, "row_header": false, "placeholder": false, "ref": "#/tables/0" }, { "location": [ 396.82, 639.15, 496.22, 655.86 ], "text": "203 (65%)", "html_text": "203 (65%)", "links": [], "cell_header_index": 3, "rowspan": 1, "colspan": 1, "column_header": false, "row_header": false, "placeholder": false, "ref": "#/tables/0" } ], "ref": "#/tables/0" }, { "row_index": 3, "location": [ 98.6201, 622.44, 496.22, 639.15 ], "cells": [ { "location": [ 98.6201, 622.44, 198.0201, 639.15 ], "text": "Interventional", "html_text": "Interventional", "links": [], "cell_header_index": 0, "rowspan": 1, "colspan": 1, "column_header": false, "row_header": false, "placeholder": false, "ref": "#/tables/0" }, { "location": [ 198.0201, 622.44, 297.4201, 639.15 ], "text": "5133 (38%)", "html_text": "5133 (38%)", "links": [], "cell_header_index": 1, "rowspan": 1, "colspan": 1, 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It comprises three stages:", "reading_order": 5 }, { "page": 12, "type": "LIST_ITEM", "location": { "l": 141.0916, "t": 416.88, "r": 523.0946, "b": 385.92 }, "text": "Medicines & Healthcare products Regulatory Agency and Research Ethics Committee combined review decision - target is 60 days.", "marker": "•", "list_id": "L4", "level": 0, "reading_order": 6 }, { "page": 12, "type": "LIST_ITEM", "location": { "l": 140.3717, "t": 377.76, "r": 497.6597, "b": 363.12 }, "text": "Combined review decision to study opening - target is 60 days.", "marker": "•", "list_id": "L4", "level": 0, "reading_order": 7 }, { "page": 12, "type": "LIST_ITEM", "location": { "l": 141.3315, "t": 354.96, "r": 487.1018, "b": 340.08 }, "text": "Study opening to first participant recruited - target is 30 days.", "marker": "•", "list_id": "L4", "level": 0, "reading_order": 8 }, { "page": 12, "type": "TEXT", "location": { "l": 110.8577, "t": 333.84, "r": 521.1749, "b": 207.12 }, "text": "4.2. In April 2026 the DHSC announced that average set-up time for commercial clinical trials in the UK reduced to 122 days, down from 169 the previous year, surpassing the 150-day target, which is now regarded as a milestone rather than an endpoint, at a study level. This has been attributed to a combination of reduced bureaucracy, standardised processes and investment (~£137m) in research infrastructure, with 99% of studies now receiving regulatory approvals within the 60-day target.", "reading_order": 9 }, { "page": 12, "type": "TEXT", "location": { "l": 111.3376, "t": 200.88, "r": 514.4563, "b": 153.6 }, "text": "4.3. There is an accompanying expectation that all participating trial sites (like OUH) must complete their set-up activities within 90 days, comprising two stages:", "reading_order": 10 }, { "page": 12, "type": "LIST_ITEM", "location": { "l": 140.8516, "t": 146.4, "r": 515.1762, "b": 82.8 }, "text": "Regulatory approval (Health Research Authority) or Date Site Selected, whichever comes later, to site confirmed (i.e. contract signed) - target is 60 days. During this time the Site has to confirm feasibility (clinically and operationally); agree the budget (NCVR);", "marker": "•", "list_id": "L5", "level": 0, "reading_order": 11 } ] }, { "page": 13, "items": [ { "page": 13, "type": "TEXT", "location": { "l": 158.848, "t": 769.44, "r": 512.0568, "b": 690.96 }, "text": "secure all relevant support directorate approvals (pharmacy, labs, radiology/imaging); ensure trained staff are study infrastructure in place; be ready for Site Initiation Visit and opening to recruitment; issue Capacity & Capability sign-off and execute the contract (mCTA).", "reading_order": 0 }, { "page": 13, "type": "LIST_ITEM", "location": { "l": 140.3717, "t": 683.28, "r": 522.1348, "b": 573.12 }, "text": "Site opening to first participant recruited - target is 30 days. This is the time during which the study PI and delivery team have to consent the first participant, from the ‘Date Site Ready to Start’ agreed with the study sponsor. This may be later than the Date Site Confirmed, especially for CTIMPs (drug trials). This interval between Date Site Confirmed and Date Site Ready to Start does not count towards any of the national metrics.", "marker": "•", "list_id": "L5", "level": 0, "reading_order": 1 }, { "page": 13, "type": "TITLE", "location": { "l": 69.586, "t": 566.16, "r": 147.5703, "b": 552.24 }, "text": "Performance", "reading_order": 2, "level": 3 }, { "page": 13, "type": "TEXT", "location": { "l": 110.8577, "t": 545.04, "r": 509.6573, "b": 449.76 }, "text": "4.4. The UKCRD publishes 90-day performance for all Trusts in England every month. It is restricted to all NIHR portfolio commercial interventional trials (with a few specific categories excluded) which recruited their first participant in the previous six months, and along with the 90-day metric performance it also includes a breakdown of their reports their performance to the 60- and 30-day targets.", "reading_order": 3 }, { "page": 13, "type": "TEXT", "location": { "l": 110.6177, "t": 443.28, "r": 510.857, "b": 349.2 }, "text": "4.5. The data in the Table 5 have been sourced from the UKCRD report, published on 31 March 2026. It includes for the 10 Shelford Group Trusts the percentage of studies meeting the 90- (and 60- and 30-) day targets for all commercial interventional trials that recruited their first participant during the six months ending 20 March 2026, i.e. during the second half of 2025-26.", "reading_order": 4 }, { "page": 13, "type": "TEXT", "location": { "l": 110.8577, "t": 342.48, "r": 525.2541, "b": 295.68 }, "text": "4.6. The ‘ranking’ has been added to show the performance of OUH and the other Shelford Group Trusts relative to each other, and to all Trusts in England.", "reading_order": 5 }, { "page": 13, "type": "TEXT", "location": { "l": 111.0976, "t": 288.96, "r": 508.9374, "b": 210 }, "text": "4.7. For the 90-day target, OUH ranked 6th out of the 10 Shelford Group and 43rd out of 73 Trusts in England which recruited the first participant to more than two commercial interventional trials in the second half of 2025-26. OUH is in the third quartile for performance against the 60- and 30-day targets.", "reading_order": 6 }, { "page": 13, "type": "TEXT", "location": { "l": 110.6177, "t": 203.52, "r": 496.6999, "b": 172.56 }, "text": "4.8. Comparable data for non-commercial clinical trials is not currently available in the UKCRD reports.", "reading_order": 7 } ] }, { "page": 14, "items": [ { "page": 14, "type": "TEXT", "location": { "l": 68.88, "t": 497.8996, "r": 769.68, "b": 482.0628 }, "text": "Table 5. OUH performance to site set-up metrics H2 2025-26, relative to other Shelford Trusts and all Trusts in England (UKCRD data)", "reading_order": 0 }, { "page": 14, "type": "TABLE", "location": { "l": 35.04, "t": 470.3052, "r": 810.96, "b": 260.5875 }, "text": "
Shelford Group Trusts
90 day metric60 day metric30 day metric
TrustStudies included *%MetRank%MetRank%MetRank
EnglandShelfordEnglandShelfordEnglandShelford
Newcastle upon Tyne Hospitals NHS Foundation Trust3187%61100%8145%294
Barts Health NHS Trust4271%10279%24355%191
Manchester University NHS Foundation Trust1567%18380%23253%213
Imperial College Healthcare NHS Trust1953%24458%39653%202
University College London Hospitals NHS Foundation Trust3148%35568%30529%548
Oxford University Hospitals NHS Foundation Trust1937%43642%53732%496
Sheffield Teaching Hospitals NHS Foundation Trust729%51771%28429%517
Cambridge University Hospitals NHS Foundation Trust1527%54833%58833%415
Guy's and St Thomas' NHS Foundation Trust2719%63922%701026%559
King's College Hospital NHS Foundation Trust1718%641029%65924%6410
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The UKCRD’s immediate focus on commercial clinical trials, combined with the exclusions of rare disease and low-recruiting studies, means this report only covers around 30% of the studies OUH has set-up during this period.", "reading_order": 0 }, { "page": 15, "type": "TEXT", "location": { "l": 110.3778, "t": 700.08, "r": 517.0958, "b": 605.52 }, "text": "4.10. Notably, commercial clinical trials account for less than 50% of the studies hosted by OUH, and of these around 60% are excluded from the UKCRD 90-day performance metric. Other limitations of the current version of the UKCRD report include the rigid 6-month reporting window and the fact that a study's performance against the 60-day metric is only reported once it has recruited its first participant.", "reading_order": 1 }, { "page": 15, "type": "TEXT", "location": { "l": 110.1378, "t": 599.04, "r": 521.4149, "b": 503.52 }, "text": "4.11. A more complete comparative overview of performance can be sourced from the NIHR's NHS Trust Study set-up APP. This has been used to source data in the Tables 6 & 7 below, which show OUH's performance on the 60- and 30-day set-up metrics, compared to other Shelford Group Trusts, and to all Trusts in England, in the R&D updates provided to TME since Q3 2025-26.", "reading_order": 2 }, { "page": 15, "type": "TITLE", "location": { "l": 69.586, "t": 476.4, "r": 151.8894, "b": 461.52 }, "text": "60-day metric", "reading_order": 3, "level": 3 }, { "page": 15, "type": "TEXT", "location": { "l": 69.346, "t": 454.32, "r": 504.3783, "b": 423.84 }, "text": "Table 6. OUH performance to the 60-day metric during 2025-26 and compared to other Trusts in England", "reading_order": 4 }, { "page": 15, "type": "TABLE", "location": { "l": 69.586, "t": 418.56, "r": 500.5391, "b": 233.28 }, "text": "
60-day targetQ1 2025-26Q2 2025-26Q3 2025-26Q4 2025-26Total 2025-26
NHS TrustsStudies%Studies%Studies%Studies%Studies%
Shelford (not including OUH)4094145224101755
Met23257%23056%30057%24059%100257%
Missed17743%18444%22243%17041%75343%
OUH60514352206
Met4168%3059%1535%1733%10350%
Missed1932%2141%2865%3567%10350%
Not Shelford15771557160414156153
Met91458%92659%95860%81357%361159%
Missed66342%63141%64640%60243%254241%
Grand Total2046100%2022100%2169100%1877100%8114100%
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OUH's overall performance for the full year (50%) is lower than the average for the other Shelford Group Trusts (57%) and for all other NHS Trusts (59%).", "reading_order": 6 }, { "page": 15, "type": "TEXT", "location": { "l": 110.6177, "t": 173.04, "r": 508.4575, "b": 126.48 }, "text": "4.13. However, only 33% (17) of the 52 OUH studies assessed in Q4 met the 60-day target. This was lower than previous quarters and lower than both Shelford (59%) and other NHS Trusts (57%) in Q4.", "reading_order": 7 }, { "page": 15, "type": "TEXT", "location": { "l": 110.3778, "t": 120, "r": 506.058, "b": 88.32 }, "text": "4.14. The marked reduction in performance between Q2 (59%) and Q3-4 (35%, 33%) coincided with a change to OUH's interpretation and", "reading_order": 8 } ] }, { "page": 16, "items": [ { "page": 16, "type": "TEXT", "location": { "l": 143.731, "t": 769.92, "r": 524.2943, "b": 690.24 }, "text": "application of the definition of Date Site Selected (DSS), which is a key input to the site-level metrics. Discussions with other Trusts suggest interpretation of this key time stamp may vary. Further discussions are taking place to ensure this start time for local review is defined and implemented consistently across Shelford Trusts.", "reading_order": 0 }, { "page": 16, "type": "TITLE", "location": { "l": 69.8259, "t": 662.64, "r": 151.6494, "b": 647.76 }, "text": "30-day metric", "reading_order": 1, "level": 3 }, { "page": 16, "type": "TEXT", "location": { "l": 69.346, "t": 640.56, "r": 519.9752, "b": 609.84 }, "text": "Table 7. OUH performance against the 30-day metric during 2025-26 and compared to other Trusts in England", "reading_order": 2 }, { "page": 16, "type": "TABLE", "location": { "l": 69.346, "t": 605.52, "r": 503.6585, "b": 419.28 }, "text": "
30-day targetQ1 2025-26Q2 2025-36Q3 2025-26Q4 2025-26Total 2025-26
NHS TrustsStudies%Studies%Studies%Studies%Studies%
Shelford (Not including OUH)3213303303071288
Met10634%9329%13842%12441%46137%
Missed21566%23771%19258%18359%82763%
OUH45534733178
Met1227%1223%1738%824%4928%
Missed3373%4177%3062%2576%12972%
Not Shelford12181194122611954833
Met56147%49142%60850%53345%219346%
Missed65753%70358%61850%66255%264054%
Grand Total1584100%1577100%1603100%1535100%6299100%
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Overall performance for the full year (28%) is lower than the average for other Shelford Group Trusts (37%) and for all other NHS Trusts (46%).", "reading_order": 4 }, { "page": 16, "type": "TEXT", "location": { "l": 110.6177, "t": 344.88, "r": 514.2163, "b": 281.28 }, "text": "4.2. 24% (8)3 of the 33 OUH studies assessed in Q4 2025-26 met the 30-day target. This is similar to Q1 (23%) in Q1 and Q2 (23%) but lower than Q3 (38%) and lower than both Shelford (41%) and other NHS Trusts (45%) in Q4.", "reading_order": 5 }, { "page": 16, "type": "TEXT", "location": { "l": 68.6262, "t": 113.28, "r": 517.8156, "b": 76.8 }, "text": "3 The number of OUH studies assessed for the 30-day metric is just under half the number assessed for the 60-day metric. This is due to a number of national exclusions, including studies with low recruitment targets.", "reading_order": 6 } ] }, { "page": 17, "items": [ { "page": 17, "type": "TITLE", "location": { "l": 69.346, "t": 769.44, "r": 248.5899, "b": 755.28 }, "text": "Recruitment to time and target", "reading_order": 0, "level": 3 }, { "page": 17, "type": "TEXT", "location": { "l": 110.3778, "t": 747.6, "r": 521.8948, "b": 685.2 }, "text": "4.3. Table 8 shows overall recruitment to time and target for studies closed to recruitment in 2025-26 was 52%, much lower than the closely related target in the UK Clinical Research Delivery Performance Indicators, which is 80% of open studies recruiting to time and target.", "reading_order": 1 }, { "page": 17, "type": "TEXT", "location": { "l": 69.8259, "t": 678.24, "r": 403.8386, "b": 663.84 }, "text": "Table 8. OUH hosted studies closed to recruitment in 2025-26", "reading_order": 2 }, { "page": 17, "type": "TABLE", "location": { "l": 110.3778, "t": 653.04, "r": 484.2224, "b": 432 }, "text": "
Study TypeNumber closed to recruitment in 2025-26Recruitment completed to time and target (%)
Recruitment time AND target met (%)Recruitment target met or exceeded (%)
Commercial6035 (58%)44 (73%)
Non-commercial11455 (48%)68 (60%)
Interventional11258 (52%)71 (63%)
Non-interventional6232 (52%)41 (66%)
NIHR portfolio16184 (52%)104 (65%)
Non-portfolio136 (46%)8 (62%)
All17490 (52%)112 (64%)
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"placeholder": false, "ref": "#/tables/0" }, { "location": [ 297.3001, 432, 390.7613, 456.56 ], "text": "90 (52%)", "html_text": "90 (52%)", "links": [], "cell_header_index": 2, "rowspan": 1, "colspan": 1, "column_header": false, "row_header": false, "placeholder": false, "ref": "#/tables/0" }, { "location": [ 390.7613, 432, 484.2224, 456.56 ], "text": "112 (64%)", "html_text": "112 (64%)", "links": [], "cell_header_index": 3, "rowspan": 1, "colspan": 1, "column_header": false, "row_header": false, "placeholder": false, "ref": "#/tables/0" } ], "ref": "#/tables/0" } ], "n_rows": 9, "n_cols": 4, "ref": "#/tables/0", "reading_order": 3 }, { "page": 17, "type": "TEXT", "location": { "l": 110.8577, "t": 403.68, "r": 526.2139, "b": 277.2 }, "text": "4.4. The proportion of studies at OUH which recruit to time and target needs to be increased substantially. Current levels of recruitment performance present a reputational risk, poor use of resources, missed opportunities for patients and – for commercial studies – a failure to leverage the initial investment in study set-up to generate surplus funds. This is a key area to be addressed in the R&D strategy currently in development, in order to align all those involved in OUH research delivery.", "reading_order": 4 }, { "page": 17, "type": "TEXT", "location": { "l": 110.8577, "t": 271.2, "r": 518.0556, "b": 112.08 }, "text": "4.5. The percentage of studies which recruited to (or exceeded) their target, including those that took longer than agreed to meet/exceed their target, is significantly higher. An analysis of all 22 studies that completed recruitment in 2025-26 and had met (or exceeded) their recruitment target but missed their recruitment window demonstrates that 17 (77%) over-ran their recruitment window by ≤10% (see Figure 5 below). This suggests that improvements which bring forward recruitment by only a small margin – including faster set-up times – should have a significant impact on the Trust’s overall recruitment to time and target.", "reading_order": 5 } ] }, { "page": 18, "items": [ { "page": 18, "type": "FIGURE", "location": { "l": 72.4654, "t": 768.48, "r": 520.695, "b": 568.32 }, "text": "", "reading_order": 0 }, { "page": 18, "type": "TEXT", "location": { "l": 69.1061, "t": 557.76, "r": 469.1054, "b": 542.4 }, "text": "Figure 5. Studies which met recruitment target but overshot the target date", "reading_order": 1 }, { "page": 18, "type": "TITLE", "location": { "l": 69.1061, "t": 517.68, "r": 474.8643, "b": 502.08 }, "text": "5. Initiatives to improve site set-up and recruitment performance", "reading_order": 2, "level": 3 }, { "page": 18, "type": "TEXT", "location": { "l": 110.8577, "t": 494.64, "r": 517.3357, "b": 448.08 }, "text": "5.1. A wide range of local initiatives have been initiated across several domains, with the aim of improving site set-up speed to meet national targets.", "reading_order": 3 }, { "page": 18, "type": "TITLE", "location": { "l": 111.8175, "t": 441.12, "r": 214.5168, "b": 426 }, "text": "Data & Reporting", "reading_order": 4, "level": 3 }, { "page": 18, "type": "TEXT", "location": { "l": 110.8577, "t": 419.28, "r": 525.0142, "b": 356.4 }, "text": "5.2. The Oxford-specified linked research portfolio databases, Siteline and Studyline, have been updated to support the move from a prioritisation process which had been built upon a fixed quota of studies to open per month, to one which is driven by the 60-day clock.", "reading_order": 5 }, { "page": 18, "type": "TEXT", "location": { "l": 111.0976, "t": 349.68, "r": 520.935, "b": 286.32 }, "text": "5.3. Microsofts PowerBI tools used in-house to track R&D activity have been updated to align with national policy expectations on commercial trial initiation and recruitment performance, and to provide more granular insights into delays within OUH approval processes.", "reading_order": 6 }, { "page": 18, "type": "TEXT", "location": { "l": 111.0976, "t": 280.08, "r": 522.8546, "b": 217.92 }, "text": "5.4. Internal OUH reports are also being updated to include the 60-day clock, increasing transparency across the board. The metric clock now features prominently in all communications with Pls and delivery teams, service support directorates and sponsors.", "reading_order": 7 }, { "page": 18, "type": "TEXT", "location": { "l": 110.8577, "t": 210.48, "r": 514.2163, "b": 163.92 }, "text": "5.5. Local OUH reports will continue to be extended and adapted, e.g. to identify studies that are excluded from national metrics, e.g. because they are defined as ‘rare disease’ or ‘low recruiting’.", "reading_order": 8 }, { "page": 18, "type": "TEXT", "location": { "l": 111.0976, "t": 156.96, "r": 521.6548, "b": 126.72 }, "text": "5.6. Performance on study set up is currently reported monthly to the Trust Delivery Committee.", "reading_order": 9 } ] }, { "page": 19, "items": [ { "page": 19, "type": "TITLE", "location": { "l": 112.0574, "t": 769.2, "r": 186.6824, "b": 755.76 }, "text": "Governance", "reading_order": 0, "level": 3 }, { "page": 19, "type": "TEXT", "location": { "l": 111.0976, "t": 747.84, "r": 515.896, "b": 685.68 }, "text": "5.7. R&D Pay Panel, chaired by CMO, was established from August 2025 as a new, discrete pathway specifically to review requests relating to fully externally-funded research posts, which are not included in the Trust headcount.", "reading_order": 1 }, { "page": 19, "type": "TEXT", "location": { "l": 111.3376, "t": 678.48, "r": 516.6159, "b": 647.52 }, "text": "5.8. R&D Committee, chaired by Director of R&D, established from March 2026, along with 14 Research Delivery Groups (RDGs).", "reading_order": 2 }, { "page": 19, "type": "TEXT", "location": { "l": 137.0124, "t": 639.6, "r": 514.9362, "b": 529.68 }, "text": "The establishment of a Trust R&D Committee was a key recommendation of the BDO internal audit of R&D in 2024-25 and received approval from the Trust Management Executive in August 2025. Its purpose is to provide assurance and strategic oversight of research governance, performance, and delivery across the Trust, ensuring research is safe, compliant, high-performing, and aligned to organisational goals", "reading_order": 3 }, { "page": 19, "type": "TITLE", "location": { "l": 111.3376, "t": 523.68, "r": 312.1771, "b": 508.56 }, "text": "Commercial study costing (NCVR)", "reading_order": 4, "level": 3 }, { "page": 19, "type": "TEXT", "location": { "l": 111.3376, "t": 501.6, "r": 519.2553, "b": 375.12 }, "text": "5.9. As described in more detail in Section 10.11, OUH has moved to automatic acceptance of the National Contract Value Review (NCVR) of commercial studies. This means the Trust no longer reviews individual study budgets received for commercial studies that have been agreed between the Sponsor and the lead NHS site under the NCVR process. This change was approved by TME in June 2026 and reflects a commitment to reduce research administration and improve study set up performance.", "reading_order": 5 }, { "page": 19, "type": "TITLE", "location": { "l": 111.0976, "t": 368.64, "r": 485.4222, "b": 353.52 }, "text": "Improved Joint Working, especially with the University of Oxford", "reading_order": 6, "level": 3 }, { "page": 19, "type": "TEXT", "location": { "l": 111.0976, "t": 346.8, "r": 515.6561, "b": 252.24 }, "text": "5.10. A working group led by the CMO has identified issues and opportunities to improve joint working between the Oxford Joint Research Office (JRO) partner organisations, especially with regards to expediting study set-up. A programme of work has been initiated, led by the Chief Operating Officer, Oxford Academic Health Partners (OAHP).", "reading_order": 7 }, { "page": 19, "type": "TEXT", "location": { "l": 110.8577, "t": 245.52, "r": 523.5745, "b": 167.04 }, "text": "5.11. A workshop of key stakeholders from all for partner organisations in the JRO in March 2026 identified several priority areas. An action plan has been prepared and funding secured from the RRDN to cover the costs of appointing a dedicated full time ‘JRO Transformation Lead’ for six months, from June 2026, to drive this forward.", "reading_order": 8 } ] }, { "page": 20, "items": [ { "page": 20, "type": "TITLE", "location": { "l": 111.8175, "t": 769.44, "r": 234.1928, "b": 755.76 }, "text": "R&D Team Structure", "reading_order": 0, "level": 3 }, { "page": 20, "type": "TEXT", "location": { "l": 111.0976, "t": 747.36, "r": 524.0544, "b": 621.12 }, "text": "5.12. A proposal is in development for a new R&D team structure to facilitate a proportionate/risk-based approach to study review. This will take greater advantage of reviews already completed by others, streamline and expedite set-up, and help avoid duplication in accordance with the ‘do things once’ approach advocated by the UKCRD, NIHR and DHSC. A new core team of R&D generalists is proposed, who will be responsible for setting up ‘straightforward’ studies, and a team member will ‘own’ and act as the primary R&D lead/pathfinder for each study.", "reading_order": 1 }, { "page": 20, "type": "TEXT", "location": { "l": 110.6177, "t": 614.64, "r": 513.0166, "b": 568.08 }, "text": "5.13. Specialist R&D teams (contracts, finance, governance) will still be required to support the set-up of more complex studies, but they can be scaled-back and staff reassigned to the new generalist team.", "reading_order": 2 }, { "page": 20, "type": "TEXT", "location": { "l": 111.0976, "t": 561.36, "r": 515.6561, "b": 530.16 }, "text": "5.14. This proposed change will require new Job Descriptions and a formal Management of Change consultation.", "reading_order": 3 }, { "page": 20, "type": "TITLE", "location": { "l": 111.8175, "t": 523.44, "r": 261.5473, "b": 508.8 }, "text": "Clinical Support Services", "reading_order": 4, "level": 3 }, { "page": 20, "type": "TEXT", "location": { "l": 111.3376, "t": 501.12, "r": 522.1348, "b": 422.64 }, "text": "5.15. Pharmacy and Radiology play a critical role in supporting clinical research at OUH. Pharmacy issued green light for only 5-10 new Clinical Trials of Investigational Medical Products (CTIMPs; drug trials) per month in 2025-26, but the demand was for more than 20/month. A recovery plan has been developed and is being implemented.", "reading_order": 5 }, { "page": 20, "type": "TEXT", "location": { "l": 110.8577, "t": 415.68, "r": 515.896, "b": 353.28 }, "text": "5.16. Radiology approval capacity has also delayed study set-up on a regular basis. Senior leaders in Radiology have agreed significant changes in process which have been implemented. These changes will increase time sensitive resources and streamline their processes.", "reading_order": 6 }, { "page": 20, "type": "TITLE", "location": { "l": 68.6262, "t": 328.56, "r": 322.255, "b": 313.2 }, "text": "6. Clinical Research Delivery Workforce", "reading_order": 7, "level": 3 }, { "page": 20, "type": "TEXT", "location": { "l": 89.7419, "t": 305.28, "r": 517.3357, "b": 258.96 }, "text": "6.1. Central to the delivery of the Trust's research portfolio is the clinical research delivery workforce. There are over 370 individuals working in 38 research delivery teams covering most clinical areas across the OUH.", "reading_order": 8 }, { "page": 20, "type": "TEXT", "location": { "l": 90.2218, "t": 251.52, "r": 523.3345, "b": 204.96 }, "text": "6.2. Approximately 60% of the clinical research delivery workforce are employees of OUH, and around 40% (140) are employed by the University of Oxford and have honorary contracts with OUH.", "reading_order": 9 }, { "page": 20, "type": "TEXT", "location": { "l": 90.2218, "t": 198.24, "r": 517.8156, "b": 136.56 }, "text": "6.3. The clinical research delivery workforce are predominantly registered nurses, but also include administrators, AHP & midwives and an increasing number of Clinical Research Practitioners (CRPs) - see Figure 6.", "reading_order": 10 } ] }, { "page": 21, "items": [ { "page": 21, "type": "FIGURE", "location": { "l": 115.6567, "t": 766.8, "r": 477.9837, "b": 554.88 }, "text": "", "reading_order": 0 }, { "page": 21, "type": "TEXT", "location": { "l": 72.4654, "t": 545.76, "r": 298.4998, "b": 529.92 }, "text": "Figure 6. Clinical Research Delivery roles", "reading_order": 1 }, { "page": 21, "type": "TEXT", "location": { "l": 89.7419, "t": 523.92, "r": 525.0142, "b": 443.52 }, "text": "6.4. Funding of OUH research delivery posts comes from a variety of sources (see Figure 7). The biggest of these is the annual award from the NIHR, via the South Central Regional Research Delivery Network (RRDN), which will be progressively reduced over the coming years as research funding is diverted away from acute Trusts to other settings.", "reading_order": 2 }, { "page": 21, "type": "FIGURE", "location": { "l": 116.1366, "t": 415.92, "r": 476.064, "b": 203.28 }, "text": "", "reading_order": 3 }, { "page": 21, "type": "TEXT", "location": { "l": 69.1061, "t": 192.24, "r": 447.7497, "b": 175.92 }, "text": "Figure 7. Sources of funding for OUH Clinical Research Delivery posts", "reading_order": 4 } ] }, { "page": 22, "items": [ { "page": 22, "type": "TEXT", "location": { "l": 111.3376, "t": 769.92, "r": 525.0142, "b": 674.88 }, "text": "6.5. The “Agile” research delivery team previously part of OUH is now employed by University Hospitals Southampton as part of the Regional Research Delivery Network (RRDN) Agile team. Currently, they continue to support to a portfolio of OUH studies using Honorary Contracts with OUH, but this team with be withdrawn in August 2026 (see section 6.9).", "reading_order": 0 }, { "page": 22, "type": "TEXT", "location": { "l": 111.0976, "t": 668.64, "r": 497.6597, "b": 637.2 }, "text": "6.6. A Task & Finish Group was established in Q4 2025-26 to address three emerging risks to the clinical research delivery teams:", "reading_order": 1 }, { "page": 22, "type": "TEXT", "location": { "l": 111.3376, "t": 630.72, "r": 521.1749, "b": 520.32 }, "text": "6.7. The first priority was to. minimise the impact of reduced RDN funding.\nOUH has been awarded £8.47m in 2026-27, a reduction of 2.8% in cash terms compared to 2025-26. Funding reductions vary across delivery teams but are being mitigated through the use of R&D reserves, with staffing not expected to constrain patient study recruitment in 2026–27. It is anticipated that national policy shifts towards non-acute settings will reduce funding further in 2027–28.", "reading_order": 2 }, { "page": 22, "type": "TEXT", "location": { "l": 111.0976, "t": 513.6, "r": 522.8546, "b": 371.28 }, "text": "6.8. The second priority was to manage the withdrawal of support from the Agile team, employed by the RRDN, which will be deploying them to support research delivery in non-acute settings in the future. The affected studies have been mapped to best-fit OUH delivery teams and the work has been absorbed within existing capacity. The only exception is surgical oncology, which requires a new team and the business case for this has been approved by TME. The posts in this team will be funded by the block funding provided to OUH by the RDN, for delivering NIHR portfolio research.", "reading_order": 3 }, { "page": 22, "type": "TEXT", "location": { "l": 111.3376, "t": 365.28, "r": 525.2541, "b": 254.64 }, "text": "6.9. The third priority is to develop a proposal to restructure the clinical research delivery workforce to ensure clear lines of reporting and accountability of the 38 teams delivering research at OUH. The current arrangements are complex (~40% staff employed by OU), limiting flexibility, responsiveness and efficiency. In this regard, OUH remains an outlier and this complexity presents ongoing operational and assurance risks.", "reading_order": 4 }, { "page": 22, "type": "TEXT", "location": { "l": 111.5775, "t": 247.92, "r": 525.2541, "b": 89.04 }, "text": "6.10. We are developing a career pathway for clinical research delivery staff and have implemented generic job descriptions for consistency and capabilities. Engagement with the workforce is achieved through the Lead NMAHPs Clinical Research Delivery (CRD) Forum for senior staff and the NMAHPs CRD network group for more junior staff. Ongoing workstreams include creating SOPs with an electronic system to track compliance, developing a bi-monthly induction programme and short modules on My Learning Hub, and enhancing advanced practice roles in clinical research delivery. Further details are available in the Appendix.", "reading_order": 5 } ] }, { "page": 23, "items": [ { "page": 23, "type": "TITLE", "location": { "l": 68.1463, "t": 751.44, "r": 436.472, "b": 735.84 }, "text": "7. NIHR Oxford Biomedical Research Centre (Oxford BRC)", "reading_order": 0, "level": 3 }, { "page": 23, "type": "TEXT", "location": { "l": 111.3376, "t": 728.4, "r": 513.9764, "b": 618.48 }, "text": "7.1. OUH holds the main contract with the DHSC for the NIHR Oxford BRC. The Trust therefore has legal and financial responsibility for delivering the funded programme, with the University of Oxford as its formal partner. The Oxford BRC is one of 20 BRCs across England and supports high-quality early translational (bench-to-bedside) and experimental research across 15 research themes and six ‘enabling hubs’.", "reading_order": 1 }, { "page": 23, "type": "TEXT", "location": { "l": 111.3376, "t": 611.76, "r": 513.4965, "b": 564.24 }, "text": "7.2. The original award for the current Oxford BRC was £86.6m for the period of 1 December 2022 – 30 November 2027. In March 2024 the award was extended by four months until 31 March 2028.", "reading_order": 2 }, { "page": 23, "type": "TEXT", "location": { "l": 111.3376, "t": 558.24, "r": 523.8144, "b": 462.96 }, "text": "7.3. The BRC supported 311 (19%) of the 1667 OUH-hosted clinical research studies that were active during 2025-26. This included salary support for investigators associated with the project, use of the BRC facilities or direct project funding. A small number of examples of recent high-impact research enabled by the BRC are provided in the Appendix.", "reading_order": 3 }, { "page": 23, "type": "TEXT", "location": { "l": 111.3376, "t": 456.96, "r": 504.3783, "b": 377.52 }, "text": "7.4. The BRC also supported 20 career development awards across a range of career stages (internships, pre-doctoral fellowships, post-doctoral awards and senior research fellowships). The pre-doctoral and post-doctoral fellowships are all supported with one-to-one mentoring.", "reading_order": 4 }, { "page": 23, "type": "TEXT", "location": { "l": 111.3376, "t": 371.28, "r": 525.734, "b": 213.36 }, "text": "7.5. In June 2026 NIHR announced their intention to fund a further round of BRCs with funding from 1 April 2028 to 31 March 2033. The deadline for the outline application is 17 September 2026 and the full application in March 2027. Researchers from across OUH and the University of Oxford have submitted expressions of interest for new themes to be included in the next BRC. Notably, for the first time, Trusts' performance in setting-up clinical trials will be taken into account in any BRC funding awarded to them, with a reduction of up to 10% (equating to ~£5m for the maximum £50m bid) for those falling below a target of 95% meeting the 90-day site set up metric.", "reading_order": 5 }, { "page": 23, "type": "TITLE", "location": { "l": 68.6262, "t": 206.4, "r": 423.2747, "b": 192 }, "text": "Patient and Public Involvement and Engagement in Research", "reading_order": 6, "level": 3 }, { "page": 23, "type": "TEXT", "location": { "l": 110.8577, "t": 184.56, "r": 521.1749, "b": 89.28 }, "text": "7.6. NIHR now require organisations that host multiple NIHR infrastructure awards to submit a single Public and Patient Involvement, Engagement and Participation (PPIEP) strategy which sets out a shared, strategic approach for the infrastructure awards it holds – for OUH this is the Oxford BRC and Oxford CRF. This will be supported by a specific action plan that feeds into the institutional strategy. It has", "reading_order": 7 } ] }, { "page": 24, "items": [ { "page": 24, "type": "TEXT", "location": { "l": 143.0112, "t": 769.2, "r": 513.0166, "b": 707.04 }, "text": "been developed in Spring 2026 with significant input from key partners, including public contributors. It will be submitted to NIHR in August 2026 and will take effect from 1 April 2027. Progress will be overseen by the R&D Committee.", "reading_order": 0 }, { "page": 24, "type": "TEXT", "location": { "l": 110.8577, "t": 700.32, "r": 523.8144, "b": 621.6 }, "text": "7.7. The Oxford BRC held a joint Health Research Showcase with the Oxford Health BRC at the Westgate Shopping Centre on 29 May 2025. This is an opportunity to showcase the broad range of research that takes place in Oxford, how it benefits NHS patients and how members of the public can get involved in clinical trials.", "reading_order": 1 }, { "page": 24, "type": "TEXT", "location": { "l": 110.8577, "t": 614.88, "r": 515.1762, "b": 568.56 }, "text": "7.8. The Oxford BRC holds regular public talks, aimed at engaging the public in its research, recordings of which are available on the BRC's YouTube channel.", "reading_order": 2 }, { "page": 24, "type": "TITLE", "location": { "l": 68.6262, "t": 543.36, "r": 415.5962, "b": 527.52 }, "text": "8. NIHR Oxford Clinical Research Facility (Oxford CRF)", "reading_order": 3, "level": 3 }, { "page": 24, "type": "TEXT", "location": { "l": 110.6177, "t": 520.32, "r": 522.3747, "b": 441.6 }, "text": "8.1. The Oxford CRF is an NIHR-funded facility that provides the specialist environment and staff to deliver early-phase and experimental clinical research. It is hosted by OUH and delivered in partnership with the University of Oxford, facilitated by a Collaboration Agreement between both organisations.", "reading_order": 4 }, { "page": 24, "type": "TEXT", "location": { "l": 111.0976, "t": 435.36, "r": 512.0568, "b": 387.6 }, "text": "8.2. Now in its fourth year of operation, the Oxford CRF has continued to expand the scope and volume of activity in line with its strategic objectives. Highlights for 2025-26 include:", "reading_order": 5 }, { "page": 24, "type": "TEXT", "location": { "l": 111.3376, "t": 381.36, "r": 523.0946, "b": 334.32 }, "text": "8.3. Over 43 studies supported within the Oxford CRF. This is a 43% increase compared to 2024-25. 30 of the studies supported in 2025-26 were commercially sponsored.", "reading_order": 6 }, { "page": 24, "type": "TEXT", "location": { "l": 110.8577, "t": 327.6, "r": 498.8594, "b": 280.8 }, "text": "8.4. 129 flexi-sigmoidoscopies and 50 bronchoscopy procedures have been delivered for clinical research studies, representing a steady increase in procedural support activity for research studies.", "reading_order": 7 }, { "page": 24, "type": "TEXT", "location": { "l": 111.0976, "t": 273.84, "r": 506.7778, "b": 227.52 }, "text": "8.5. Working with commercial partners and haematology colleagues – medical and nursing – set-up the first non-oncology CAR-T study to recruit participants at OUH.", "reading_order": 8 }, { "page": 24, "type": "TEXT", "location": { "l": 111.3376, "t": 220.56, "r": 520.695, "b": 174.72 }, "text": "8.6. Working with colleagues in the Oxford BRC to develop the institutional PPIE strategy required by the NIHR, and hosting PPIE events in the CRF.", "reading_order": 9 }, { "page": 24, "type": "TEXT", "location": { "l": 111.0976, "t": 167.04, "r": 517.8156, "b": 87.12 }, "text": "8.7. Following a successful OUH bid for additional funds from the NIHR, preparations are being made for the Oxford CRF, along with the Oxford Experimental Cancer Medicine Centre (ECMC), to pilot a cloud-based system for managing essential study documentation (the Investigator Site File (ISF)) for new studies being set-up during 2026-", "reading_order": 10 } ] }, { "page": 25, "items": [ { "page": 25, "type": "TEXT", "location": { "l": 143.4911, "t": 769.44, "r": 523.3345, "b": 659.28 }, "text": "27. This is expected to result in significant time savings and improvements to quality that will benefit Pls and study delivery teams, as well as OUH and sponsors (who will no longer have to travel to OUH to review essential documents relating to their studies). The R&D Information Systems team is closely involved and if the pilot is successful, plans to support rolling this out across the Trust, as part of the NHS shift from analogue to digital.", "reading_order": 0 }, { "page": 25, "type": "TEXT", "location": { "l": 110.8577, "t": 653.04, "r": 514.6963, "b": 588.72 }, "text": "8.8. As the CRF portfolio grows, current processes and oversight structures have been reviewed and aligned further with modifications in Trust R&D processes; further work is being undertaken to explore supporting more Phase 1 trials and studies involving cellular therapy.", "reading_order": 1 }, { "page": 25, "type": "TITLE", "location": { "l": 68.6262, "t": 564.72, "r": 228.6739, "b": 550.08 }, "text": "9. Research Governance", "reading_order": 2, "level": 3 }, { "page": 25, "type": "TEXT", "location": { "l": 111.0976, "t": 542.16, "r": 507.0178, "b": 447.12 }, "text": "9.1. An interim R&D Committee operated between October 2025 and March 2026 while the new governance arrangements were being established. During this period, leads for 14 new Research Delivery Groups (RDGs) were appointed through an open, transparent and competitive process. The RDG leads are now members of the R&D Committee, completing its full establishment.", "reading_order": 3 }, { "page": 25, "type": "TEXT", "location": { "l": 110.8577, "t": 440.64, "r": 492.3807, "b": 409.68 }, "text": "9.2. A summary of the governance frameworks governing research is available in the Appendix.", "reading_order": 4 }, { "page": 25, "type": "TITLE", "location": { "l": 70.0659, "t": 384.96, "r": 190.7615, "b": 369.84 }, "text": "10. R&D Finance", "reading_order": 5, "level": 3 }, { "page": 25, "type": "TEXT", "location": { "l": 112.0574, "t": 361.44, "r": 525.0142, "b": 234.96 }, "text": "10.1. The R&D Finance team provides management accounting, costing, and pre- and post-award financial support to researchers and for infrastructure grants. This includes managing finances for the Oxford BRC, and the CRF, and the delivery funds received from the South Central Regional Research Delivery Network (SCRDN); acting as lead site for National Contract Value Reviews (NCVR) when the CI is based at OUH; reviewing and costing study budgets and amendments; and managing commercial study income to support R&D activities.", "reading_order": 6 } ] }, { "page": 26, "items": [ { "page": 26, "type": "TITLE", "location": { "l": 68.8661, "t": 769.68, "r": 349.8495, "b": 755.52 }, "text": "Position and Current Activities to 31 March 2026", "reading_order": 0, "level": 3 }, { "page": 26, "type": "TEXT", "location": { "l": 112.2974, "t": 743.52, "r": 524.5343, "b": 664.56 }, "text": "10.2. For the 2025-26 financial year, the annual income and expenditure budget for R&D was set at £45 million, as shown below. This included £27 million received from the NIHR, mainly for hosting the Oxford BRC and block funding to support the workforce and infrastructure to support the delivery of portfolio studies.", "reading_order": 1 }, { "page": 26, "type": "TEXT", "location": { "l": 112.0574, "t": 658.8, "r": 396.88, "b": 642.96 }, "text": "10.3. High level breakdown of 2025-26 R&D budget:", "reading_order": 2 }, { "page": 26, "type": "TABLE", "location": { "l": 69.586, "t": 620.88, "r": 525.2541, "b": 511.44 }, "text": "
Research Funding typeExpenditure (£m)
NIHR Oxford Biomedical Research Centre (BRC)18
NIHR Regional Research Delivery Network (RRDN)9
NIHR Research Capability Funding (RCF)1
Other income (commercial & non-commercial, incl. NIHR grants)17
Total 45
", "rows": [ { "row_index": 0, "location": [ 69.586, 602.64, 525.2541, 620.88 ], "cells": [ { "location": [ 69.586, 602.64, 297.4201, 620.88 ], "text": "Research Funding type", "html_text": "Research Funding type", "links": [], "cell_header_index": 0, "rowspan": 1, "colspan": 1, "column_header": false, "row_header": false, "placeholder": false, "ref": "#/tables/0" }, { "location": [ 297.4201, 602.64, 525.2541, 620.88 ], "text": "Expenditure (£m)", "html_text": "Expenditure (£m)", "links": [], "cell_header_index": 1, "rowspan": 1, "colspan": 1, "column_header": false, "row_header": false, "placeholder": false, "ref": "#/tables/0" } ], "ref": "#/tables/0" }, { "row_index": 1, "location": [ 69.586, 584.4, 525.2541, 602.64 ], "cells": [ { "location": [ 69.586, 584.4, 297.4201, 602.64 ], "text": "NIHR Oxford Biomedical Research Centre (BRC)", "html_text": "NIHR Oxford Biomedical Research Centre (BRC)", "links": [], "cell_header_index": 0, "rowspan": 1, "colspan": 1, "column_header": false, "row_header": false, "placeholder": false, "ref": "#/tables/0" }, { "location": [ 297.4201, 584.4, 525.2541, 602.64 ], "text": "18", "html_text": "18", "links": [], "cell_header_index": 1, "rowspan": 1, "colspan": 1, "column_header": false, "row_header": false, "placeholder": false, "ref": "#/tables/0" } ], "ref": "#/tables/0" }, { "row_index": 2, "location": [ 69.586, 566.16, 525.2541, 584.4 ], "cells": [ { "location": [ 69.586, 566.16, 297.4201, 584.4 ], "text": "NIHR Regional Research Delivery Network (RRDN)", "html_text": "NIHR Regional Research Delivery Network (RRDN)", "links": [], "cell_header_index": 0, "rowspan": 1, "colspan": 1, "column_header": false, "row_header": false, "placeholder": false, "ref": "#/tables/0" }, { "location": [ 297.4201, 566.16, 525.2541, 584.4 ], "text": "9", "html_text": "9", "links": [], "cell_header_index": 1, "rowspan": 1, "colspan": 1, "column_header": false, "row_header": false, "placeholder": false, "ref": "#/tables/0" } ], "ref": "#/tables/0" }, { "row_index": 3, "location": [ 69.586, 547.92, 525.2541, 566.16 ], "cells": [ { "location": [ 69.586, 547.92, 297.4201, 566.16 ], "text": "NIHR Research Capability Funding (RCF)", "html_text": "NIHR Research Capability Funding (RCF)", "links": [], "cell_header_index": 0, "rowspan": 1, "colspan": 1, "column_header": false, "row_header": false, "placeholder": false, "ref": "#/tables/0" }, { "location": [ 297.4201, 547.92, 525.2541, 566.16 ], "text": "1", "html_text": "1", "links": [], "cell_header_index": 1, "rowspan": 1, "colspan": 1, "column_header": false, "row_header": false, "placeholder": false, "ref": "#/tables/0" } ], "ref": "#/tables/0" }, { "row_index": 4, "location": [ 69.586, 529.68, 525.2541, 547.92 ], "cells": [ { "location": [ 69.586, 529.68, 297.4201, 547.92 ], "text": "Other income (commercial & non-commercial, incl. NIHR grants)", "html_text": "Other income (commercial & non-commercial, incl. NIHR grants)", "links": [], "cell_header_index": 0, "rowspan": 1, "colspan": 1, "column_header": false, "row_header": false, "placeholder": false, "ref": "#/tables/0" }, { "location": [ 297.4201, 529.68, 525.2541, 547.92 ], "text": "17", "html_text": "17", "links": [], "cell_header_index": 1, "rowspan": 1, "colspan": 1, "column_header": false, "row_header": false, "placeholder": false, "ref": "#/tables/0" } ], "ref": "#/tables/0" }, { "row_index": 5, "location": [ 69.586, 511.44, 525.2541, 529.68 ], "cells": [ { "location": [ 69.586, 511.44, 297.4201, 529.68 ], "text": "", "html_text": "", "links": [], "cell_header_index": 0, "rowspan": 1, "colspan": 1, "column_header": false, "row_header": false, "placeholder": false, "ref": "#/tables/0" }, { "location": [ 297.4201, 511.44, 525.2541, 529.68 ], "text": "Total 45", "html_text": "Total 45", "links": [], "cell_header_index": 1, "rowspan": 1, "colspan": 1, "column_header": false, "row_header": false, "placeholder": false, "ref": "#/tables/0" } ], "ref": "#/tables/0" } ], "n_rows": 6, "n_cols": 2, "ref": "#/tables/0", "reading_order": 3 }, { "page": 26, "type": "TEXT", "location": { "l": 111.5775, "t": 489.6, "r": 517.5757, "b": 441.84 }, "text": "10.4. At financial year end all major NIHR programme and smaller grants achieved a breakeven position and individual study income exceeded expenditure by £2.6 million.", "reading_order": 4 }, { "page": 26, "type": "TITLE", "location": { "l": 69.586, "t": 416.16, "r": 275.2245, "b": 400.8 }, "text": "Research Capability Funding (RCF)", "reading_order": 5, "level": 3 }, { "page": 26, "type": "TEXT", "location": { "l": 112.2974, "t": 394.08, "r": 519.4953, "b": 282.96 }, "text": "10.5. NIHR RCF is awarded to help research-active NHS organisations to act flexibly and strategically to maintain research capacity and capability; support the appointment, development and retention of key staff undertaking people and patient-based research; and contribute towards the costs of hosting NIHR-funded or ‘adopted’ research that are not currently fully covered across NIHR’s programmes, and that are not met in other ways.", "reading_order": 6 }, { "page": 26, "type": "TEXT", "location": { "l": 112.0574, "t": 276.96, "r": 521.4149, "b": 214.8 }, "text": "10.6. OUH received £580k of RCF in 2025-26 (compared to £1.3m in 2024-25). This is due to a decrease in the NIHR grant income during the previous calendar year, which is the main basis on which RCF awards are calculated.", "reading_order": 7 }, { "page": 26, "type": "TEXT", "location": { "l": 112.2974, "t": 207.84, "r": 522.6147, "b": 96.24 }, "text": "10.7. The panel that oversees RCF at OUH made a number of individual awards in support of NIHR-funded research in OUH and the University of Oxford to cover absences as a result of parental or long-term sick leave. This provided essential support to ensure NIHR-funded research could continue. RCF also made a significant contribution towards research overhead costs and the costs of managing NIHR grants.", "reading_order": 8 } ] }, { "page": 27, "items": [ { "page": 27, "type": "TITLE", "location": { "l": 69.586, "t": 770.16, "r": 227.4741, "b": 755.28 }, "text": "Financial Planning 2026-27", "reading_order": 0, "level": 3 }, { "page": 27, "type": "TEXT", "location": { "l": 112.7773, "t": 744, "r": 399.5195, "b": 728.64 }, "text": "10.8. The following budget has been set for 2026-27:", "reading_order": 1 }, { "page": 27, "type": "TABLE", "location": { "l": 80.6237, "t": 725.04, "r": 517.3357, "b": 610.56 }, "text": "
Research Funding by area2026-27
Expenditure budget (£m)
NIHR Oxford Biomedical Research Centre (BRC)18
NIHR Regional Research Delivery Network (RRDN)9
NIHR Research Capability Funding (RCF)1
Other income (commercial & non-commercial, incl. NIHR grants)24
Total52
", "rows": [ { "row_index": 0, "location": [ 80.6237, 692.3314, 517.3357, 725.04 ], "cells": [ { "location": [ 80.6237, 692.3314, 298.9797, 725.04 ], "text": "Research Funding by area", "html_text": "Research Funding by area", "links": [], "cell_header_index": 0, "rowspan": 2, "colspan": 1, "column_header": false, "row_header": false, "placeholder": false, "ref": "#/tables/0" }, { "location": [ 298.9797, 708.6857, 517.3357, 725.04 ], "text": "2026-27", "html_text": "2026-27", "links": [], "cell_header_index": 1, "rowspan": 1, "colspan": 1, "column_header": false, "row_header": false, "placeholder": false, "ref": "#/tables/0" } ], "ref": "#/tables/0" }, { "row_index": 1, "location": [ 298.9797, 692.3314, 517.3357, 708.6857 ], "cells": [ { "location": [ 298.9797, 692.3314, 517.3357, 708.6857 ], "text": "Expenditure budget (£m)", "html_text": "Expenditure budget (£m)", "links": [], "cell_header_index": 1, "rowspan": 1, "colspan": 1, "column_header": false, "row_header": false, "placeholder": false, "ref": "#/tables/0" } ], "ref": "#/tables/0" }, { "row_index": 2, "location": [ 80.6237, 675.9771, 517.3357, 692.3314 ], "cells": [ { "location": [ 80.6237, 675.9771, 298.9797, 692.3314 ], "text": "NIHR Oxford Biomedical Research Centre (BRC)", "html_text": "NIHR Oxford Biomedical Research Centre (BRC)", "links": [], "cell_header_index": 0, "rowspan": 1, "colspan": 1, "column_header": false, "row_header": false, "placeholder": false, "ref": "#/tables/0" }, { "location": [ 298.9797, 675.9771, 517.3357, 692.3314 ], "text": "18", "html_text": "18", "links": [], "cell_header_index": 1, "rowspan": 1, "colspan": 1, "column_header": false, "row_header": false, "placeholder": false, "ref": "#/tables/0" } ], "ref": "#/tables/0" }, { "row_index": 3, "location": [ 80.6237, 659.6229, 517.3357, 675.9771 ], "cells": [ { "location": [ 80.6237, 659.6229, 298.9797, 675.9771 ], "text": "NIHR Regional Research Delivery Network (RRDN)", "html_text": "NIHR Regional Research Delivery Network (RRDN)", "links": [], "cell_header_index": 0, "rowspan": 1, "colspan": 1, "column_header": false, "row_header": false, "placeholder": false, "ref": "#/tables/0" }, { "location": [ 298.9797, 659.6229, 517.3357, 675.9771 ], "text": "9", "html_text": "9", "links": [], "cell_header_index": 1, "rowspan": 1, "colspan": 1, "column_header": false, "row_header": false, "placeholder": false, "ref": "#/tables/0" } ], "ref": "#/tables/0" }, { "row_index": 4, "location": [ 80.6237, 643.2686, 517.3357, 659.6229 ], "cells": [ { "location": [ 80.6237, 643.2686, 298.9797, 659.6229 ], "text": "NIHR Research Capability Funding (RCF)", "html_text": "NIHR Research Capability Funding (RCF)", "links": [], "cell_header_index": 0, "rowspan": 1, "colspan": 1, "column_header": false, "row_header": false, "placeholder": false, "ref": "#/tables/0" }, { "location": [ 298.9797, 643.2686, 517.3357, 659.6229 ], "text": "1", "html_text": "1", "links": [], "cell_header_index": 1, "rowspan": 1, "colspan": 1, "column_header": false, "row_header": false, "placeholder": false, "ref": "#/tables/0" } ], "ref": "#/tables/0" }, { "row_index": 5, "location": [ 80.6237, 626.9143, 517.3357, 643.2686 ], "cells": [ { "location": [ 80.6237, 626.9143, 298.9797, 643.2686 ], "text": "Other income (commercial & non-commercial, incl. NIHR grants)", "html_text": "Other income (commercial & non-commercial, incl. NIHR grants)", "links": [], "cell_header_index": 0, "rowspan": 1, "colspan": 1, "column_header": false, "row_header": false, "placeholder": false, "ref": "#/tables/0" }, { "location": [ 298.9797, 626.9143, 517.3357, 643.2686 ], "text": "24", "html_text": "24", "links": [], "cell_header_index": 1, "rowspan": 1, "colspan": 1, "column_header": false, "row_header": false, "placeholder": false, "ref": "#/tables/0" } ], "ref": "#/tables/0" }, { "row_index": 6, "location": [ 80.6237, 610.56, 517.3357, 626.9143 ], "cells": [ { "location": [ 80.6237, 610.56, 298.9797, 626.9143 ], "text": "Total", "html_text": "Total", "links": [], "cell_header_index": 0, "rowspan": 1, "colspan": 1, "column_header": false, "row_header": false, "placeholder": false, "ref": "#/tables/0" }, { "location": [ 298.9797, 610.56, 517.3357, 626.9143 ], "text": "52", "html_text": "52", "links": [], "cell_header_index": 1, "rowspan": 1, "colspan": 1, "column_header": false, "row_header": false, "placeholder": false, "ref": "#/tables/0" } ], "ref": "#/tables/0" } ], "n_rows": 7, "n_cols": 2, "ref": "#/tables/0", "reading_order": 2 }, { "page": 27, "type": "TEXT", "location": { "l": 112.7773, "t": 600.24, "r": 507.0178, "b": 569.52 }, "text": "10.9. As in previous years the BRC and RRDN budgets forecast a break-even position for 2026-27.", "reading_order": 3 }, { "page": 27, "type": "TEXT", "location": { "l": 112.0574, "t": 562.56, "r": 525.0142, "b": 515.52 }, "text": "10.10. For budget setting purposes it had been assumed that OUH will receive a similar level of RCF funding to last year (£580k). An award of £1.123m was confirmed in June 2026.", "reading_order": 4 }, { "page": 27, "type": "TEXT", "location": { "l": 112.0574, "t": 508.8, "r": 516.6159, "b": 461.28 }, "text": "10.11. The budget for income (and expenditure) from commercial and other non-commercial studies, including other NIHR grants, has been set at £24 million which is based on income trends in recent years.", "reading_order": 5 }, { "page": 27, "type": "TITLE", "location": { "l": 69.586, "t": 437.52, "r": 275.2245, "b": 421.44 }, "text": "11. Research Contracts and IP", "reading_order": 6, "level": 3 }, { "page": 27, "type": "TEXT", "location": { "l": 111.3376, "t": 414.24, "r": 510.1372, "b": 382.8 }, "text": "11.1. During 2025-26, 1,445 research and IP related cases were finalised. Further details are provided in the Appendix.", "reading_order": 7 }, { "page": 27, "type": "TITLE", "location": { "l": 69.8259, "t": 358.08, "r": 231.3134, "b": 342.48 }, "text": "12. Acknowledgements", "reading_order": 8, "level": 3 }, { "page": 27, "type": "TEXT", "location": { "l": 112.2974, "t": 335.04, "r": 497.6597, "b": 288.24 }, "text": "12.1. The lead authors would like to thank the following colleagues for drafting relevant sections of this report and all the members of the teams they lead, whose work it describes:", "reading_order": 9 }, { "page": 27, "type": "LIST_ITEM", "location": { "l": 143.4911, "t": 280.32, "r": 407.4379, "b": 265.44 }, "text": "Jennifer Anderson (Head of BRC Operations)", "marker": "•", "list_id": "L6", "level": 0, "reading_order": 10 }, { "page": 27, "type": "LIST_ITEM", "location": { "l": 143.731, "t": 258.24, "r": 367.6059, "b": 242.88 }, "text": "Kirsten Bailey (Head of R&D Finance)", "marker": "•", "list_id": "L6", "level": 0, "reading_order": 11 }, { "page": 27, "type": "LIST_ITEM", "location": { "l": 143.2511, "t": 235.44, "r": 430.2333, "b": 219.84 }, "text": "Tim Bradford (Head of R&D Information Systems)", "marker": "•", "list_id": "L6", "level": 0, "reading_order": 12 }, { "page": 27, "type": "LIST_ITEM", "location": { "l": 143.4911, "t": 212.64, "r": 462.3868, "b": 197.28 }, "text": "Cushla Cooper (Clinical Operational Lead, Oxford CRF)", "marker": "•", "list_id": "L6", "level": 0, "reading_order": 13 }, { "page": 27, "type": "LIST_ITEM", "location": { "l": 143.2511, "t": 189.84, "r": 524.5343, "b": 158.88 }, "text": "Shahista Hussain (Head of R&D Governance; Deputy Head of R&D Operations)", "marker": "•", "list_id": "L6", "level": 0, "reading_order": 14 }, { "page": 27, "type": "LIST_ITEM", "location": { "l": 143.2511, "t": 151.2, "r": 451.1091, "b": 136.32 }, "text": "Charles Lescott (Head of IP and Research Contracts)", "marker": "•", "list_id": "L6", "level": 0, "reading_order": 15 }, { "page": 27, "type": "LIST_ITEM", "location": { "l": 143.2511, "t": 128.88, "r": 496.6999, "b": 113.04 }, "text": "Sandie Wellman (Head of NMAHP Clinical Research Delivery)", "marker": "•", "list_id": "L6", "level": 0, "reading_order": 16 } ] }, { "page": 28, "items": [ { "page": 28, "type": "TITLE", "location": { "l": 69.1061, "t": 769.2, "r": 219.3158, "b": 754.56 }, "text": "13. Recommendation", "reading_order": 0, "level": 3 }, { "page": 28, "type": "TEXT", "location": { "l": 111.8175, "t": 746.16, "r": 477.7437, "b": 731.76 }, "text": "13.1. The Trust Board is asked to receive this report for information.", "reading_order": 1 } ] }, { "page": 29, "items": [ { "page": 29, "type": "TITLE", "location": { "l": 77.7443, "t": 769.44, "r": 142.2913, "b": 753.36 }, "text": "Appendix", "reading_order": 0, "level": 3 }, { "page": 29, "type": "TITLE", "location": { "l": 69.1061, "t": 728.4, "r": 322.7349, "b": 713.04 }, "text": "14. Research activity by OUH Division", "reading_order": 1, "level": 3 }, { "page": 29, "type": "TEXT", "location": { "l": 110.8577, "t": 705.36, "r": 524.0544, "b": 593.28 }, "text": "14.1. Figure 8 presents a breakdown of the 1667 active studies of all types hosted by the Trust in 2025-26, according to the Divisions that are actively involved in their delivery. Many studies involve more than one Division, with the Clinical Support Services Division (CSS) being involved in the largest number – usually providing pharmacy, radiology and imaging, or pathology and laboratory services to studies recruiting patients under the care of one of the other Divisions.", "reading_order": 2 }, { "page": 29, "type": "FIGURE", "location": { "l": 71.7455, "t": 588, "r": 521.6548, "b": 275.52 }, "text": "", "reading_order": 3 }, { "page": 29, "type": "TEXT", "location": { "l": 111.0976, "t": 247.68, "r": 459.7473, "b": 231.84 }, "text": "Figure 8. Active research studies at OUH in 2025-26, by Division", "reading_order": 4 } ] }, { "page": 30, "items": [ { "page": 30, "type": "TITLE", "location": { "l": 69.346, "t": 769.44, "r": 340.4914, "b": 754.32 }, "text": "15. Clinical Research Delivery Workforce", "reading_order": 0, "level": 3 }, { "page": 30, "type": "TEXT", "location": { "l": 112.2974, "t": 745.92, "r": 520.935, "b": 683.76 }, "text": "15.1. We continue to develop the career pathway for clinical research delivery staff, which is essential to deliver our research agenda. In line with this, generic job descriptions have now been implemented to ensure consistency and appropriate capabilities within each role.", "reading_order": 1 }, { "page": 30, "type": "TEXT", "location": { "l": 112.5373, "t": 676.8, "r": 519.7352, "b": 646.56 }, "text": "15.2. Engagement with the clinical research delivery workforce across OUH is achieved through two key regular meetings:", "reading_order": 2 }, { "page": 30, "type": "LIST_ITEM", "location": { "l": 144.4509, "t": 637.68, "r": 517.8156, "b": 495.6 }, "text": "The Lead NMAHPs Clinical Research Delivery (CRD) Forum. This well-established forum offers team leaders (band/grade 7 and above) the opportunity to come together to share information from the Trust/NIHR/University, best practice, identify issues (and solutions), agree trust wide processes for delivery, provide peer support and share information. On-going workstreams include introduction of a study intensity tool to measure capacity, a link NMAHP role for research in care delivery areas and extension of placements for pre-registration students.", "marker": "•", "list_id": "L7", "level": 0, "reading_order": 3 }, { "page": 30, "type": "LIST_ITEM", "location": { "l": 143.2511, "t": 488.16, "r": 523.5745, "b": 442.08 }, "text": "The NMAHPs CRD network group. This offers the opportunity for more junior staff (band/grade 6 and below) to come together, share ideas, gain peer support.", "marker": "•", "list_id": "L7", "level": 0, "reading_order": 4 }, { "page": 30, "type": "TEXT", "location": { "l": 105.3388, "t": 434.4, "r": 477.0238, "b": 420 }, "text": "Several ongoing workstreams are being undertaken by these groups:", "reading_order": 5 }, { "page": 30, "type": "TEXT", "location": { "l": 111.3376, "t": 413.04, "r": 519.4953, "b": 318.96 }, "text": "15.3. Developing a suite of SOPs which will be applicable to all research delivery staff and will introduce a clear governance structure. An electronic system for issuing SOPs with the ability to track receipt and acknowledgement is being developed and will be introduced during 2025-26. This will enable the Trust to evidence distribution and compliance with best practice across the research delivery workforce.", "reading_order": 6 }, { "page": 30, "type": "TEXT", "location": { "l": 112.5373, "t": 311.52, "r": 521.4149, "b": 122.4 }, "text": "15.4. Developing an induction programme for all research delivery staff.\nNMAHP research leaders are now present at all Trust induction sessions. This will be delivered bi-monthly and will ensure all research delivery staff receive the same initial training. There is also a plan to make five short modules available on My Learning Hub for all OUH staff as an introduction to clinical research, to raise awareness of research and how staff can be involved. This is in line with the CQC well-led inspection framework which emphasizes the importance of research awareness in NHS Trusts as part of its well-led framework, and encourages trusts to actively facilitate and promote research, ensuring that staff have opportunities to engage with research and innovation.", "reading_order": 7 }, { "page": 30, "type": "TEXT", "location": { "l": 112.2974, "t": 115.68, "r": 507.4977, "b": 84.72 }, "text": "15.5. Developing enhanced and advanced practice in clinical research delivery. Several research delivery staff have completed training for", "reading_order": 8 } ] }, { "page": 31, "items": [ { "page": 31, "type": "TEXT", "location": { "l": 143.4911, "t": 769.44, "r": 524.7742, "b": 706.8 }, "text": "enhanced practice including non-medical prescribing and advanced history taking, and there is one advanced clinical practitioner in post. A pathway to support Advance Practice roles is being developed with the Trust lead for advanced practice.", "reading_order": 0 }, { "page": 31, "type": "TITLE", "location": { "l": 69.8259, "t": 682.08, "r": 191.7214, "b": 666.48 }, "text": "16. Study impact", "reading_order": 1, "level": 3 }, { "page": 31, "type": "TEXT", "location": { "l": 112.0574, "t": 659.04, "r": 525.0142, "b": 500.64 }, "text": "16.1. The high volume and variety of clinical research hosted by OUH has important benefits for our patients, and major reputational and other benefits for the Trust. OUH-University of Oxford clinical research has had major impacts on patient care in the Oxford region, the NHS nationally, and internationally, in areas as diverse as infection control and treatment, vaccines, genomics, imaging, digital health and artificial intelligence, cancer, respiratory, diabetes, surgical innovations and many others. These advances have established new diagnostics and treatments, changed clinical guidelines for many conditions and have led to multiple spin-out companies.", "reading_order": 2 }, { "page": 31, "type": "TEXT", "location": { "l": 112.5373, "t": 494.16, "r": 521.6548, "b": 479.04 }, "text": "16.2. Recent examples of high-impact research carried out at OUH include:", "reading_order": 3 }, { "page": 31, "type": "LIST_ITEM", "location": { "l": 117.0964, "t": 471.36, "r": 524.2943, "b": 392.88 }, "text": "The DETECT study demonstrated that an experimental imaging agent may help to locate endometriosis lesions that standard scans can miss and could represent a non-invasive tool for diagnosing and monitoring the condition, which could benefit millions of women across the world.", "marker": "•", "list_id": "L8", "level": 0, "reading_order": 4 }, { "page": 31, "type": "LIST_ITEM", "location": { "l": 118.5361, "t": 385.2, "r": 517.0958, "b": 322.32 }, "text": "Two world firsts have taken place in trials at OUH to tackle the blood cancer myeloma. One of the trials is testing a new tracer to be used on myeloma patients during PET-CT scans; the other is investigating a new potential drug combination therapy.", "marker": "•", "list_id": "L8", "level": 0, "reading_order": 5 }, { "page": 31, "type": "LIST_ITEM", "location": { "l": 118.7761, "t": 314.88, "r": 523.5745, "b": 252.48 }, "text": "The CRAFFT trial suggests that most children with a severely broken wrist can be treated without surgery and instead a cast-first approach delivers similar long-term recovery while reducing the risks associated with surgery and costs.", "marker": "•", "list_id": "L8", "level": 0, "reading_order": 6 }, { "page": 31, "type": "LIST_ITEM", "location": { "l": 118.0562, "t": 244.56, "r": 524.5343, "b": 102.48 }, "text": "The first population-level study published links first-trimester ultrasound practice with early detection rates for serious congenital anomalies. Early screening resulted in earlier detection for 40% of anomalies, including heart and limb issues. The findings have significant implications for national screening policy, parental decision-making, and equity of care. Despite technological advances making early detection possible, there is no national policy recommending first-trimester anatomical screening in England, leading to striking regional differences in practice.", "marker": "•", "list_id": "L8", "level": 0, "reading_order": 7 } ] }, { "page": 32, "items": [ { "page": 32, "type": "LIST_ITEM", "location": { "l": 117.8163, "t": 768.72, "r": 524.0544, "b": 674.16 }, "text": "The UK's COVID Inquiry praised the speed with which the Oxford/AstraZeneca COVID vaccine was developed and the rapid set-up of the Oxford-led RECOVERY trial, which identified the first effective treatment for COVID. It said the infrastructure established by the National Institute for Health and Care Research (NIHR) was critical to the successful delivery of clinical trials during the pandemic.", "marker": "•", "list_id": "L8", "level": 0, "reading_order": 0 }, { "page": 32, "type": "TITLE", "location": { "l": 69.586, "t": 649.44, "r": 246.9102, "b": 634.56 }, "text": "17. Research Governance", "reading_order": 1, "level": 3 }, { "page": 32, "type": "TITLE", "location": { "l": 70.0659, "t": 626.64, "r": 144.9308, "b": 612 }, "text": "Background", "reading_order": 2, "level": 3 }, { "page": 32, "type": "TEXT", "location": { "l": 113.0172, "t": 603.84, "r": 522.8546, "b": 494.64 }, "text": "17.1. Research governance refers to the framework to manage the research process from end to end, to ensure that research is undertaken in a safe, appropriate and ethical manner, in accordance with national guidance and applicable laws to ensure that maximum benefit is derived from research for public and patients. Compliance with the legislation is overseen nationally by the Health Research Authority. This includes:", "reading_order": 3 }, { "page": 32, "type": "TEXT", "location": { "l": 112.0574, "t": 487.44, "r": 523.8144, "b": 424.8 }, "text": "17.2. UK Policy Framework for Health and Social Care 2017 - The UK policy framework sets out principles of good practice in the management and conduct of health and social care research that take account of legal requirements and other standards.", "reading_order": 4 }, { "page": 32, "type": "TEXT", "location": { "l": 112.5373, "t": 418.08, "r": 517.5757, "b": 228.24 }, "text": "17.3. ICH Good Clinical Practice (GCP) – GCP is a set of internationally recognised ethical and scientific quality requirements for designing, conducting, recording and reporting research that involves human participation. Compliance provides public assurance that the rights, safety and wellbeing of participants are respected and protected, and that the data generated are credible and accurate. In the first major overhaul in nearly a decade, ICH-GCP E6 (R3) was implemented globally during 2025-26. The updates modernise structure and terminology, promote a more proportionate, quality-by-design approach to trial design, accommodate decentralisation and digital readiness, adopt a participant-centred approach to informed consent, and streamline operations and reporting.", "reading_order": 5 }, { "page": 32, "type": "TEXT", "location": { "l": 112.0574, "t": 221.76, "r": 523.5745, "b": 95.04 }, "text": "17.4. EU Directives - The EU Clinical Trials Directive (EUCTD – 2001/20/EC) sets out how clinical trials investigating the safety or efficacy of a medicinal product in humans must be conducted. It includes medicinal trials with healthy volunteers and small scale or pilot studies. The Good Clinical Practice (GCP) Directive (2005/28/EC) supplements the EUCTD, strengthening the legal basis for requiring member states to comply with the principles and guidelines of good clinical practice. After leaving the EU the UK implemented the EUCTD", "reading_order": 6 } ] }, { "page": 33, "items": [ { "page": 33, "type": "TEXT", "location": { "l": 143.4911, "t": 769.68, "r": 518.2955, "b": 739.2 }, "text": "(which become an EU Regulation on 31 January 2022), into domestic legislation.", "reading_order": 0 }, { "page": 33, "type": "TEXT", "location": { "l": 112.2974, "t": 732, "r": 525.0142, "b": 669.36 }, "text": "17.5. Medicines for Human Use (Clinical Trials) Regulations 2025 has been approved and will come into effect from 28^{th} April 2026. The aim of the updated legislation is to streamline approvals, enhance patient safety, and accelerate access to innovative treatments.", "reading_order": 1 }, { "page": 33, "type": "TEXT", "location": { "l": 112.5373, "t": 662.16, "r": 519.0154, "b": 568.32 }, "text": "17.6. Human Tissue Act - The Human Tissue Act 2004 repealed and replaced the Human Tissue Act 1961, the Anatomy Act 1984 and the Human Organ Transplants Act 1989 as they related to England and Wales, and the corresponding orders in Northern Ireland. The Human Tissue Authority regulates the removal, storage, use and disposal of human bodies, organs and tissue.", "reading_order": 2 }, { "page": 33, "type": "TEXT", "location": { "l": 112.2974, "t": 561.36, "r": 521.6548, "b": 498.72 }, "text": "17.7. Declaration of Helsinki - The Declaration of Helsinki was developed by the World Medical Association as 'a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data' (Para 1, Declaration of Helsinki).", "reading_order": 3 }, { "page": 33, "type": "TEXT", "location": { "l": 112.7773, "t": 492, "r": 522.8546, "b": 397.68 }, "text": "17.8. General Data Protection Regulation (GDPR) - Most clinical research requires the processing and/or storage of personal and sensitive information. The General Data Protection Regulation (GDPR) legislates for the control and protection of personal information relating to living individuals including both facts and opinions about the individual.", "reading_order": 4 }, { "page": 33, "type": "TEXT", "location": { "l": 112.7773, "t": 390.72, "r": 522.1348, "b": 279.6 }, "text": "17.9. Mental Capacity Act - Research studies involving adults aged 16 or over who lack capacity must comply with the Mental Capacity Act 2005. This includes persons with dementia, learning disabilities, mental health problems, stroke or head injuries who may lack capacity to make certain decisions, including consenting to participate in a research study. The act does not apply to studies falling under the Clinical Trials Regulations (CTIMPs).", "reading_order": 5 }, { "page": 33, "type": "TEXT", "location": { "l": 112.7773, "t": 273.6, "r": 499.8193, "b": 227.04 }, "text": "17.10. OUH Frameworks for R&D Governance, Training and Monitoring – Locally, clinical research is governed by the following OUH policies:", "reading_order": 6 }, { "page": 33, "type": "LIST_ITEM", "location": { "l": 161.7274, "t": 219.12, "r": 384.6425, "b": 204.24 }, "text": "Safety Reporting in Clinical Research", "marker": "•", "list_id": "L9", "level": 0, "reading_order": 7 }, { "page": 33, "type": "LIST_ITEM", "location": { "l": 161.9674, "t": 196.32, "r": 405.5183, "b": 181.92 }, "text": "Sponsorship of Clinical Research Studies", "marker": "•", "list_id": "L9", "level": 0, "reading_order": 8 }, { "page": 33, "type": "LIST_ITEM", "location": { "l": 161.7274, "t": 174.24, "r": 450.8691, "b": 159.12 }, "text": "Trust Management Approval for Clinical Research", "marker": "•", "list_id": "L9", "level": 0, "reading_order": 9 }, { "page": 33, "type": "LIST_ITEM", "location": { "l": 161.7274, "t": 151.2, "r": 406.958, "b": 136.32 }, "text": "Monitoring and Audit of Research Studies", "marker": "•", "list_id": "L9", "level": 0, "reading_order": 10 }, { "page": 33, "type": "LIST_ITEM", "location": { "l": 161.4874, "t": 128.64, "r": 521.1749, "b": 98.16 }, "text": "Research Passports, Honorary Research Contracts and Letters of Access", "marker": "•", "list_id": "L9", "level": 0, "reading_order": 11 } ] }, { "page": 34, "items": [ { "page": 34, "type": "LIST_ITEM", "location": { "l": 161.9674, "t": 768.24, "r": 378.1638, "b": 753.84 }, "text": "Management of Intellectual Property", "marker": "•", "list_id": "L9", "level": 0, "reading_order": 0 }, { "page": 34, "type": "LIST_ITEM", "location": { "l": 162.2073, "t": 746.16, "r": 295.3805, "b": 731.52 }, "text": "Integrity in Research", "marker": "•", "list_id": "L9", "level": 0, "reading_order": 1 }, { "page": 34, "type": "LIST_ITEM", "location": { "l": 161.4874, "t": 723.12, "r": 484.7023, "b": 708.96 }, "text": "Consent for use of clinical samples and data in research.", "marker": "•", "list_id": "L9", "level": 0, "reading_order": 2 }, { "page": 34, "type": "TEXT", "location": { "l": 147.0904, "t": 701.52, "r": 525.4941, "b": 623.04 }, "text": "These policies are underpinned by a suite of Standard Operating Procedures (SOPs) within R&D governance. Policies and SOPs are updated in response to national and local developments. The OUH R&D Governance team conducts a wide variety of activities, which are summarised below.", "reading_order": 3 }, { "page": 34, "type": "TITLE", "location": { "l": 69.586, "t": 594.72, "r": 280.0236, "b": 579.84 }, "text": "Oversight of Compliance and Safety", "reading_order": 4, "level": 3 }, { "page": 34, "type": "TEXT", "location": { "l": 111.8175, "t": 572.64, "r": 524.2943, "b": 493.2 }, "text": "17.11. GCP Monitoring. The purpose of monitoring is to ensure that the safety of participants is assured; that the trial results will be credible and accurate and that the trial is conducted in accordance with the protocol and regulatory frameworks. The R&D Governance team undertakes monitoring visits for each OUH-sponsored regulated trial.", "reading_order": 5 }, { "page": 34, "type": "TEXT", "location": { "l": 112.5373, "t": 487.2, "r": 522.8546, "b": 312.72 }, "text": "17.12. Formal auditing of compliance. An audit is part of implementing quality assurance. It is independent and separate from routine monitoring or quality control functions. The purpose of an audit is to evaluate a system(s) or trial conduct and compliance with the protocol, SOPs, Good Clinical Practice (GCP), and the applicable regulatory requirements. Where OUH is hosting research with an external Sponsor, such trials may be audited by the R&D Governance team, which now has three lead auditors. These trials are selected through a risk-based approach. Due to other priorities no audits were conducted by the R&D Governance team during 2025-26, however 3 studies have been highlighted for audits during the next year.", "reading_order": 6 }, { "page": 34, "type": "TEXT", "location": { "l": 113.0172, "t": 306.72, "r": 522.8546, "b": 131.76 }, "text": "17.13. Compliance checks. The R&D Governance team also routinely undertakes assessment of compliance with various aspects of clinical research; primarily focussing on informed consent and safety reporting. These brief checks are of great value for oversight of compliance and as they are less resource intensive than formal audit, a greater number of studies can be covered. During 2025-2026 29 informed consent and 4 safety compliance checks have been completed. The findings were fed back to the relevant teams. They will be summarised and shared in an anonymised format with all the research delivery teams working across OUH, to help improve quality and promote best practice.", "reading_order": 7 }, { "page": 34, "type": "TEXT", "location": { "l": 111.8175, "t": 126.72, "r": 514.2163, "b": 78.72 }, "text": "17.14. To support investigators and research teams, the R&D Governance team and Head of NMAHP Clinical Research Delivery formally facilitate regulatory inspections of research conduct at OUH.", "reading_order": 8 } ] }, { "page": 35, "items": [ { "page": 35, "type": "TEXT", "location": { "l": 143.4911, "t": 769.2, "r": 520.935, "b": 707.04 }, "text": "This allows trends and best practice to be highlighted and communicated to improve standards across the Trust. During 2025-26 one MHRA (Medicines and Healthcare Products Regulatory Agency) site inspection was supported.", "reading_order": 0 }, { "page": 35, "type": "TEXT", "location": { "l": 111.5775, "t": 700.32, "r": 521.4149, "b": 462.48 }, "text": "17.15. Safety Reporting. As Sponsor, the OUH is responsible for regulatory assessment of Serious Adverse Events (SAEs). As host organisation, the Trust has a responsibility for ensuring that safety reporting processes are appropriate and compliant. The appropriate level of oversight is established by a risk assessment prior to the granting of Trust Management Approval, for both sponsored and hosted trials. All SAEs reported are reviewed by the OUH/University of Oxford Joint Trials Safety Group (TSG). The aims of this review are to: pick up any trends, such as increases in un/expected events, and take appropriate action; identify whether additional advice or information is required from investigators; evaluate the risk of the trial continuing and take appropriate action where necessary, including requests for specific audits. During 2025-26 OUH has reviewed 95 SAEs which have also been presented at the quarterly Trial Safety Group meetings.", "reading_order": 1 }, { "page": 35, "type": "TEXT", "location": { "l": 112.2974, "t": 456.24, "r": 519.7352, "b": 345.84 }, "text": "17.16. Organisational Information Document (OID). When specified by the Sponsor, an OID can be used as the contractual agreement for non-commercial studies that are not clinical trials or clinical investigations. Unlike other site agreements with Sponsors, which are managed by the R&D Contracts team, the review; approval and completion of OIDs is managed by the R&D governance team. During 20254-26 106 OIDs were processed.", "reading_order": 2 }, { "page": 35, "type": "TEXT", "location": { "l": 112.2974, "t": 339.6, "r": 521.1749, "b": 132.48 }, "text": "17.17. Research incident reporting. The Head of NMAHP CRD reports the number of incidents relating to clinical research delivery to the R&D Committee and to the Lead NMAHPs' CRD forum on a quarterly basis, highlighting key themes and any shared learning. 254 incidents were reported in Ulysses in 2025-26, although not all were causally related to research. The breakdown by Division, in Figure 9, shows one Division (SuWON) accounts for nearly two thirds of the total. However, it is likely this is due at least in some part to variation in reporting practice across Divisions. Figure 10 shows a breakdown of reported incidents by actual impact; except for one which was Moderate, all of them were either Minor or No Harm. Figure 11 shows a breakdown of reported incidents by Incident Type, with just under two thirds affecting Patients and just under a quarter affecting Staff.", "reading_order": 3 } ] }, { "page": 36, "items": [ { "page": 36, "type": "FIGURE", "location": { "l": 93.3412, "t": 763.92, "r": 539.8912, "b": 500.16 }, "text": "", "reading_order": 0 }, { "page": 36, "type": "TEXT", "location": { "l": 91.9015, "t": 488.16, "r": 370.4853, "b": 470.88 }, "text": "Figure 9. Incidents reported on Ulysses, by Division", "reading_order": 1 }, { "page": 36, "type": "TEXT", "location": { "l": 206.3584, "t": 447.12, "r": 428.7936, "b": 430.08 }, "text": "Incident Breakdown by Actual Impact", "reading_order": 2 }, { "page": 36, "type": "FIGURE", "location": { "l": 90.7017, "t": 441.6, "r": 424.9543, "b": 190.8 }, "text": "", "reading_order": 3 }, { "page": 36, "type": "TEXT", "location": { "l": 91.1816, "t": 173.52, "r": 408.1577, "b": 156.72 }, "text": "Figure 10. Incidents reported on Ulysses, by Actual Impact", "reading_order": 4 } ] }, { "page": 37, "items": [ { "page": 37, "type": "FIGURE", "location": { "l": 92.8613, "t": 762, "r": 538.9314, "b": 506.16 }, "text": "", "reading_order": 0 }, { "page": 37, "type": "TEXT", "location": { "l": 91.6615, "t": 496.08, "r": 406.718, "b": 480.48 }, "text": "Figure 11. Incidents reported on Ulysses, by Incident Type", "reading_order": 1 }, { "page": 37, "type": "TITLE", "location": { "l": 69.8259, "t": 458.88, "r": 121.8954, "b": 443.28 }, "text": "Training", "reading_order": 2, "level": 3 }, { "page": 37, "type": "TEXT", "location": { "l": 111.5775, "t": 436.8, "r": 522.6147, "b": 341.76 }, "text": "17.18. In collaboration with the University of Oxford Research Governance, Ethics and Assurance (RGEA) team, the R&D Governance team prepares and delivers the HRA and Ethics submission on-line training to both Trust and University of Oxford staff. This covers how researchers can prepare and make good submission. During 2025-2026 there have been 97 attendees.", "reading_order": 3 }, { "page": 37, "type": "TEXT", "location": { "l": 110.8577, "t": 335.04, "r": 520.695, "b": 240.72 }, "text": "17.19. In January 2026 the R&D Governance and University of Oxford RGEA teams agreed to withdraw the ‘in-house’ GCP training they had developed and delivered together for many years. Since then, OUH staff requiring GCP training have been directed to the NIHR GCP courses which have been updated in line with R6 (E3) and can be accessed online via the NIHR Learn platform.", "reading_order": 4 }, { "page": 37, "type": "TITLE", "location": { "l": 69.8259, "t": 234, "r": 191.9613, "b": 219.36 }, "text": "Classification Group", "reading_order": 5, "level": 3 }, { "page": 37, "type": "TEXT", "location": { "l": 112.0574, "t": 212.4, "r": 514.4563, "b": 85.2 }, "text": "17.20. There are times when it is not clear if a project should be classified as a research study, audit or service evaluation. In order to establish an authoritative and collective opinion on such projects, OUH's R&D Governance team have established the Classification Group to review project outlines and give a considered opinion. This group, which meets monthly, or more often where there is high demand, classified a total of 109 projects during 2025-26. 95 were reviewed at meeting and 14 were reviewed and approved by email.", "reading_order": 6 } ] }, { "page": 38, "items": [ { "page": 38, "type": "TITLE", "location": { "l": 69.346, "t": 769.44, "r": 275.2245, "b": 754.56 }, "text": "18. Research Contracts and IP", "reading_order": 0, "level": 3 }, { "page": 38, "type": "TEXT", "location": { "l": 112.2974, "t": 746.4, "r": 514.2163, "b": 684.48 }, "text": "18.1. The number of research and IP related cases finalised in 2025-26 (1445) is 9% higher than 2024-25 (1121) and is the highest caseload in any financial year to date. The breakdown of contract types is shown in Table 9.", "reading_order": 1 }, { "page": 38, "type": "TEXT", "location": { "l": 111.3376, "t": 676.8, "r": 520.4551, "b": 598.32 }, "text": "18.2. There continues to be an increase in the number of cases completed for Oxford Health NHS Foundation Trust (OH), for whom we provide a research contract service. The team has recruited an OH-funded member who was trained this year to work on OH cases but also supports OUH cases where capacity allowed and demands required.", "reading_order": 2 }, { "page": 38, "type": "TEXT", "location": { "l": 105.3388, "t": 591.6, "r": 523.0946, "b": 577.2 }, "text": "Table 9. Cases completed by the Research Contracts and IP team in 2025-26", "reading_order": 3 }, { "page": 38, "type": "TABLE", "location": { "l": 149.01, "t": 570.48, "r": 392.081, "b": 358.08 }, "text": "
Case typeNumber
Confidentiality Agreement297
Clinical Trial Site Agreement297
Amendment264
Grant Application186
Oxford Health173
Service Agreement83
Collaboration Agreement69
Assignment/Revenue Share25
Data Transfer Agreement25
Other14
MTA Donor Academic12
Total1445
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The team continues to use DocuSign to initiate and manage efficient paperless execution of agreements, including signatures for Oxford Health contracts. Use of electronic signatures during 2025 resulted in an estimated 1,750 lb reduction in carbon emissions, 2,195 gal of water conserved, 745 lb of wood saved, and 121 lb of waste eliminated.", "reading_order": 5 } ] } ]