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Liver
Review
From O’Shaughnessy to opportunity: innovating Hepatology Trials in the UK
  1. Oliver D Tavabie1,
  2. Yvanne Enever2,
  3. Daniel Green3,
  4. Helen Crisp4,
  5. Emmanouil Tsochatzis5,
  6. Amir Gander5,
  7. Dina Mansour6,
  8. Vanessa Hebditch7,
  9. Julie Adams7,
  10. Adam Ashbourn8,
  11. Christopher Mysko9,
  12. Richard Allen8,
  13. Laura Kent10,
  14. James B Maurice11,
  15. Ankur Srivastava11,
  16. Abhishek Chauhan12,
  17. Tom Johnston13,
  18. Janet Ruane8,
  19. Rebecca Varni8,
  20. Caroline Fletcher8,
  21. Cyril Sieberhagen14,
  22. Gordon Hay15,
  23. Giovanna Bretland14,
  24. Maggie Corrigan14,
  25. Francesco Ferraro14,
  26. Riley McMahon8,
  27. Trudie Burge11,
  28. Harry Ferguson8,
  29. Louise Jennings11,
  30. Brian Hogan5,
  31. Andrew Cook16,
  32. Rajiv Jalan4,5,
  33. Gautam Mehta4,5
  1. 1 Leeds Teaching Hospitals NHS Trust, Leeds, UK
  2. 2 PharmExcel Ltd, London, UK
  3. 3 Department of Bioengineering, Imperial College London, London, UK
  4. 4 Division of Medicine, University College London, London, UK
  5. 5 Royal Free London NHS Foundation Trust, London, London, UK
  6. 6 Gateshead Health NHS Foundation Trust, Gateshead, UK
  7. 7 British Liver Trust, Ringwood, UK
  8. 8 Patient/carer Representative, London, UK
  9. 9 Manchester University NHS Foundation Trust, Manchester, UK
  10. 10 Great Western Hospitals NHS Foundation Trust, Swindon, UK
  11. 11 North Bristol NHS Trust, Bristol, UK
  12. 12 University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK
  13. 13 Taunton and Somerset NHS Foundation Trust, Taunton, UK
  14. 14 Liverpool University Hospitals NHS Foundation Trust, Liverpool, UK
  15. 15 Liverpool John Moores University, Liverpool, UK
  16. 16 Southampton Clinical Trials Unit, University of Southampton, Southampton, UK
  1. Correspondence to Dr Oliver D Tavabie; oliver.tavabie{at}nhs.net; Dr Gautam Mehta; gautam.mehta{at}ucl.ac.uk

Abstract

Developing new treatments that improve outcomes for patients with decompensated cirrhosis remains an unmet area of clinical need. The UK has a rich history of being on the forefront of clinical trials for this patient group. However, there have been challenges in achieving this goal in the past decade, with several negative studies as well as trials struggling to achieve recruitment. This has been further exacerbated by the changed clinical landscape following the COVID-19 pandemic. In response to this, the O’Shaughnessy report was commissioned to identify potential opportunities to improve clinical trial performance in the UK. In this review article, we identify critical areas for the UK hepatology community to collaborate and develop sustainable partnerships for clinical trial delivery which will ensure that outcomes are representative, inclusive and patient-centred.

  • cirrhosis
  • clinical trials
  • health service research

https://doi.org/10.1136/flgastro-2024-102710

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    Footnotes

    • X @drdina_mansour, @jamesbmaurice

    • Contributors ODT, HC, RJ and GM planned the UK-CLIF meetings and facilitated them. ODT, YE, DG, HC, AC and GM wrote the first draft. GM is guarantor of the manuscript. All authors contributed to outcomes from the meeting, reviewed the draft and made critical revisions.

    • Funding This study was funded by National Institute for Health and Care Research (NIHR155694).

    • Competing interests None declared.

    • Provenance and peer review Not commissioned; externally peer reviewed.