PHARMExcel’s newest paper in Frontline Gastroenterology is now available - Clinical Trial Services, UK

We’re thrilled to announce our newest paper in Frontline Gastroenterology is now published online.

The article “From O’Shaughnessy to Opportunity: Innovating Hepatology Trials in the UK” explores the challenges and opportunities in conducting clinical trials for liver disease, particularly decompensated cirrhosis, within the UK. It reflects on historical achievements, current obstacles, and future directions to enhance clinical trial performance, emphasising the necessity of innovative approaches post-COVID-19 pandemic. The review draws on insights from the O’Shaughnessy report and the UK-Chronic Liver Failure network (UK-CLIF), highlighting key areas for improvement and collaboration.

To cite: Enever Y, Tavabie OD, Green D, et all. Frontline Gastroenterology doi 10.1136/flgastro-2024-102710

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Highlights from the report

Current Challenges in Hepatology Trials

The UK has seen a significant decline in recruitment and initiation of clinical trials over the past decade, exacerbated by the COVID-19 pandemic. Recruitment to commercial clinical trials has fallen by over 40%, and the UK’s global ranking for initiating phase III trials has slipped. The O’Shaughnessy report highlights the urgent need for streamlined clinical trial processes and better accountability to reverse this trend.

Recommendations from the O’Shaughnessy Report

The report suggests several measures to improve clinical trial performance:

Streamlining set-up processes to reduce bureaucratic delays.
Aligning trial activities with routine care.
Incentivizing clinical research for healthcare staff.
Enhancing patient recruitment through representation and inclusivity.

Addressing Representation and Diversity

Liver disease disproportionately affects underserved populations, including those from lower socio-economic backgrounds and various ethnic groups. Currently, most clinical liver research takes place around the major liver centres in the UK, neglecting some areas of high disease prevalence (figure 2) Ensuring that clinical trial participants represent the broader patient population is crucial. The creation of open research networks and adapting engagement strategies for underserved communities are recommended to improve recruitment and retention.

Connecting Stakeholders and Standardising Care

The article stresses the importance of connecting researchers, patients, and carers to increase awareness of open trials and better support patient recruitment. It advocates for the establishment of ‘buddy programs’ to mentor new investigators and the sharing of resources to enhance research activity. Standardising care practices across different regions can mitigate variations in clinical outcomes and improve the reliability of trial results.

Innovating Trial Design and Delivery

The article highlights innovative trial designs, such as platform design trials and Bayesian analysis, which offer efficiency and adaptability. Platform design, successfully used in COVID-19 research, can reduce costs and improve patient engagement by allowing several interventions to be compared with each other simultaneously. Sharing the infrastructure between multiple research questions offsets these fixed costs of trial delivery. Additionally, it allows data from control participants to be reused, allowing a greater proportion of patients entering the study to receive the novel intervention, thus making participation more attractive to patients. This trial design is also more efficient, allowing research questions to be answered by randomising fewer patients.

Enhancing Clinical Trial Career Pathways

To sustain and grow the clinical trial ecosystem, it is essential to train the next generation of healthcare professionals (HCPs) in clinical research. The article supports integrating clinical trial training into the NHS workforce plan and increasing opportunities for HCPs to lead and participate in research.

Developing the Commercial Trials Sector

The UK’s declining market share in commercial trials presents both a challenge and an opportunity. The establishment of Clinical Trial Accelerator Networks (CTANs) aims to provide top-tier clinical trials services, expediting approval and delivery processes. The liver disease sector, given its significant public health impact, is a prime candidate for investment and inclusion in these networks.

Conclusion

Rebuilding capacity for hepatology trials in the UK is imperative for addressing the growing burden of liver disease. The recommendations from the O’Shaughnessy report, alongside innovations in trial design and delivery, offer a pathway to revitalize clinical research and improve patient outcomes. By fostering collaboration, enhancing representation, and supporting career development in clinical research, the UK can reclaim its position as a leader in hepatology trials.

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Authors:

Oliver D Tavabie,1 Yvanne Enever,2 Daniel Green,3 Helen Crisp,4 Emmanouil Tsochatzis,5 Amir Gander,5 Dina Mansour ,6
Vanessa Hebditch,7 Julie Adams,7 Adam Ashbourn,8 Christopher Mysko,9 Richard Allen,8 Laura Kent,10 James B Maurice ,11 Ankur Srivastava,11 Abhishek Chauhan,12 Tom Johnston,13 Janet Ruane,8 Rebecca Varni,8 Caroline Fletcher,8 Cyril Sieberhagen,14 Gordon Hay,15
Giovanna Bretland,14 Maggie Corrigan,14 Francesco Ferraro,14
Riley McMahon,8 Trudie Burge,11 Harry Ferguson,8 Louise Jennings,11 Brian Hogan,5 Andrew Cook,16 Rajiv Jalan,4,5 Gautam Mehta4,5

Author affiliations:

¹Leeds Teaching Hospitals NHS Trust, Leeds, UK
²PharmExcel Ltd, London, UK
³Department of Bioengineering, Imperial College London, London, UK
⁴Division of Medicine, University College London, London, UK 5Royal Free London NHS Foundation Trust, London, UK 6Gateshead Health NHS Foundation Trust, Gateshead, UK 7British Liver Trust, Ringwood, UK
⁸Patient/carer Representative, London, UK
⁹Manchester University NHS Foundation Trust, Manchester, UK 10Great Western Hospitals NHS Foundation Trust, Swindon, UK 11North Bristol NHS Trust, Bristol, UK
¹²University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK
¹³Taunton and Somerset NHS Foundation Trust, Taunton, UK 14Liverpool University Hospitals NHS Foundation Trust, Liverpool, UK 15Liverpool John Moores University, Liverpool, UK
¹⁶Southampton Clinical Trials Unit, University of Southampton, Southampton, UK