The government has published its full response to Lord O’Shaughnessy’s independent review into commercial clinical trials in the UK.
The response sets out plans to make the UK one of the best places in the world for clinical trials, by implementing all of the recommendations in the review.
It follows a commitment made earlier this year to speed up clinical trials and help NHS patients access innovative new medicines and medical technologies sooner. This was backed up by investment, including £3m to the Health Research Authority.
Matt Westmore, Chief Executive at the HRA said
Matt Westmore, Chief Executive
Significant progress has been made since the government announced plans to speed up clinical trials in May 2023.
The UK’s performance in clinical research has now exceeded pre-pandemic levels, and the set-up times for commercial studies has reduced by over 100 days.
Today’s announcement gives us continued focus to make sure we cement the UK’s position as a global leader in the delivery of life sciences research. It also sets out a commitment to make that progress easy to track.
Lord O’Shaughnessy’s recommendations will make it easier and faster for NHS patients to access the latest proven innovative treatments, thanks to research that people can trust.
At the heart of the latest government response is a cross-sector collaborative and innovative approach through the Recovery Resilience and Growth programme, and we’re delighted to play our part.
Dr Janet Messer, Director of Approvals at the HRA shares more information about the projects underway to support today’s announcement
Dr Janet Messer, Director of Approvals
Working in partnership with others in the research landscape, we’ve done a lot of the groundwork to support the government’s response to the Lord O’Shaughnessy review. We’ve already started to make real progress towards improving clinical research across the UK and will continue to do so.
Streamlining research through co-ordinating and standardising practice is one of our core functions. We’ve been a partner in the development of the National Contract Value Review (NCVR). Our UK standard contracts have been updated and our new template UK finance appendix means that we really can remove all local site negotiations of costs and contracts in trials that are eligible for NCVR. We’re thrilled that NCVR is making such a difference for clinical research already, meaning trials will reach patients more quickly and sponsors can be confident to place their studies here.
The research system is strongest when organisations support each other. When there were delays in one part of clinical trials approvals, we tried to reduce the impact on research by letting applicants progress our part of the process while they were waiting. Now we’re delighted that combined review is back on track, with all regulatory approvals meeting the 60-day timeline. Our fast-track Research Ethics Committee review offers shorter timelines to the same rigorous standard.
Working with the Experimental Cancer Medicine Centres (ECMC) and our study set-up partnership board we’ve identified new areas for improvement in study set-up and are working to find and test solutions. We’re also building on what we’ve heard about the need to strengthen our support for technical assurances and information governance at sites.
Consulting on and developing new clinical trials regulations with the Medicine and Healthcare products Regulatory Agency (MHRA), we hope to foster more pragmatic and innovative ways of doing clinical research. We’ve supported the MHRA to develop a new notification scheme to reduce unnecessary burdens for research on lower risk medicines. We’re drafting new guidance to accompany the regulations, including an inclusion and diversity plan, jointly with MHRA, that helps sponsors and researchers to identify who should be included in their trials.
We’re identifying the barriers and enablers to contacting potential participants about research, and our report and further guidance is coming soon. We’ve co-created hallmarks of good people-centred clinical research, to help researchers understand how to design and conduct research that people will feel is relevant to them when they are asked about taking part. We’ve launched design principles for participant information about studies so that researchers know how to provide simple, clear information for people deciding whether to take part, and a new standard to bring more consistency in how our ethics committees review that information. We’ve set out how people-centred and decentralised ways of working are encouraged, with hub and spoke model agreements, and supporting guidance for the set-up of interventional studies. Along with our standards on good public involvement, this will help improve the experience for people when they take part in research.
This is truly an exciting time with real opportunities for focus and change. Watch this space!
Lord O’Shaughnessy has welcomed new research published by the HRA today which shows strong public support for diversity in health and social care research. The findings of the YouGov survey, conducted earlier this year, support his report’s recommendations for increased diversity in clinical trials.
The government’s planned Clinical Trials Accelerators (CTAs) have a brief to increase the diversity of populations taking part in research, complementing our work already underway.
You can read more about our public attitudes survey, and what this means for our work, in our news story.
And for the very latest news on everything we’re doing to support world-class clinical research in the UK you can sign up for our new clinical trials bulletin.