Future of UK Regulation Conference 2023: Getting UK clinical trials back on track
This is the second of four blogs reporting from the BIA conference, ‘The Future of UK Regulation: Driving innovation in the life sciences’, which looks at what is being done across the research ecosystem to get commercial clinical trials back on track in the UK.
Recommendations from the review into the UK commercial clinical trials landscape
Moves to address the fall in the number of industry sponsored trials and make the UK a more attractive destination for investment must encompass everything from scientific advice to the completion of a study. The stage has been set to achieve this by the review of commercial clinical trials carried out by Lord James O’Shaughnessy, former health minister and Senior Partner, Newmarket Strategy, which was published in May 2023.
The review set out 27 recommendations to improve the environment for commercial clinical trials. Lord O’Shaughnessy told delegates that the aim is to ‘grow the whole pie’, not to increase the number of commercial trials at the expense of academic studies, where the UK continues to perform strongly, with one million patients recruited in 2021–22. However, he said, "a competitive commercial clinical trials environment is important because it acts as a beacon of the strength of the life sciences sector as a whole."
The main reason the UK has fallen down the league table of commercial trials is that it has become much more difficult to set up trials quickly. “Of all the metrics, that is the most important one,” said Lord O’Shaughnessy.
The Medicines and Healthcare products Regulatory Agency (MHRA) put in place a plan to clear the backlog of clinical trial application that built up in 2022-23 (see below). Lord O’Shaughnessy said the foundation is in place and it is “time to look to the future and to get a really radically quick turnaround time”.
While there has been a good start in implementing the recommendations, it is necessary to maintain momentum so that the outstanding issues are addressed. “One part this group can play in that is keeping the government honest in delivering on the commitment that it has made in response to the review,” Lord O’Shaughnessy concluded.
Enabling an efficient and innovative clinical research system across the NHS
More than two years before the O’Shaughnessy review, the Future of Clinical Research Delivery set out a vision for a more patient-centred, pro-innovation and digitally enabled clinical research environment that would build on the successes and the lessons of the COVID-19 pandemic.
There are five key themes underpinning the vision: clinical research embedded in the NHS; patient-centred research; streamlined, efficient and innovative research; research enabled by data and digital tools; and a sustainable and supported research workforce.
"These are very much interdigitated with the O’Shaughnessy review and give a mandate to accelerate implementation, but in doing so it is important to recognise that no single person or organisation owns the whole of the research ecosystem," said Professor Lucy Chappell, Chief Scientific Adviser, Department of Health and Social Care and Chief Executive, National Institute for Health and Care Research (NIHR). She added: “The only way we are going to achieve this is by all team members pulling in the same direction."
The latest data demonstrate the programme of reforms have ‘grown the pie’. In October 2022, 73,940 people were recruitment to studies in England, in comparison to 80,533 trial participants in September 2023. Meanwhile, the number of participants in commercial studies increased from 2,077 in October 2022 to 5,067 in September 2023.
Regulatory measures to speed up clinical trial approval
The MHRA has taken a cross-agency approach and introduced new ways of working to address what were clearly some significant shortcomings in its clinical trials application assessment process. As a result, performance has improved and a backlog of almost 1,000 applications was cleared between July and September.
"This provides the platform to ensure that processes are further optimised and sustainable for the future, with system-wide collaboration," said James Pound, Deputy Director, Standards and Compliance, MHRA. “That brings benefits not only to the work we do at the MHRA, but collectively that brings benefits to patients, the life sciences ecosystem and the wider UK economy,” Mr Pound told delegates.
In terms of performance, the MHRA currently receives 7,000 clinical trial applications per year. These require varying levels of assessment across the core technical disciplines, all within the statutory timeframes.
In its “crisis response” to the backlog, the MHRA set up a dedicated task force, made up of redeployed and trained staff from across the agency and newly recruited assessors. The task force worked to clear the backlog over the summer, while also processing all new applications received during this time. “This represents a very, very significant increase from the normal level of throughput,” said Mr Pound.
In part, this was achieved by adopting a more risk-proportionate approach, recognising for example that first-in-human trials present very different levels of uncertainty from a phase 4 study of a licensed medicine. This allowed the MHRA to develop a more targeted assessment approach that was related to the level of risk and uncertainty, and to maximise the use of information from approvals granted by other stringent regulators to inform MHRA clinical trial approvals.
“We worked with our partners across the system to help reduce delays,” Mr Pound said. The MHRA will build on this and further refine our approach as we look to the future. From 1 September all applications received are being assessed within the statutory timelines and the agency is committed to ensuring this remains the case.
Perspective from the Health Research Authority
While the main regulatory function of the Health Research Authority (HRA) is to provide research ethics committees review, it has a second function, which is to coordinate and standardise regulatory practice for research across the UK. "That has given it a central role in underpinning the programme of work to implement a whole system approach and make the UK an attractive place to conduct clinical research," said Dr Janet Messer, Director of Approvals, HRA.
From March to August 2023, ethics reviews were completed on time. “Now that MHRA timelines are back on track, we’re in a great position to really make a difference with the combined review process,” Dr Messer told delegates.
The standard review process is complemented by a fast-track ethics review that is available to global clinical trials and phase I trials. Between March and August 2023 all fast-track ethics reviews were completed in less than 30 days; a reorganisation of operations to make things work more efficiently had brought this down to below 20 days by August.
Further time is needed for sponsors to respond to any questions. “But with an ethics review timeline of 20 days, that gives us plenty of scope to ensure you get your study up and running well within 60 days,” said Dr Messer.
For more information, please contact Dr Christiane Abouzeid, Head of Regulatory Affairs, BIA.
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