UK clinical research update
View previous versions of this newsletter and find downloadable pdf versions here.
February 2024 edition
Published 23 February 2024This monthly update summarises recent news, announcements, guidance and updates on progress towards achieving the UK vision for The Future of UK Clinical Research Delivery.
This update provides examples of how organisations are individually and collaboratively achieving the collective goal of making the UK one of the best places to conduct clinical research.
Headlines
Two national performance indicators as outlined in the Full Government Response to the O’Shaughnessy Review (November 2023) were met in January 2024.
100% of studies receiving combined regulatory review achieved within 60 days, on average, measured from Integrated Research Application System submission to combined Medicines and Healthcare products Regulatory Agency (MHRA) and Research Ethics Committee regulatory decision.
100% of NHS trusts in England accept the local price generated as part of the National Contract Value Review (NCVR) process for late-phase studies without further negotiation following agreement of the resource required by the lead site.
The latest MHRA performance data shows that all regulatory assessments for clinical trials are being completed within statutory timeframes, with initial assessment completed within an average of 26 days and assessments on amendments completed within an average of 24 days.
MHRA processing backlogs have been eliminated and improvements embedded into standard working practice.
Regulatory assessments of clinical investigations for medical devices continue to be completed within expected timeframes – there have not been any backlogs in this area.
The goal has been met to have no studies on the National Institute for Health and Care Research (NIHR) Clinical Research network (CRN) portfolio that are more than 90 days past their planned opening date.
UK Clinical Research Delivery Performance Indicators Report
The UK Clinical Research Delivery Performance Indicators Report, an evolution of the Research Status Report, incorporates a collection of system-wide UK metrics that monitor progress towards The Future of UK Clinical Research Delivery's vision.
The Department of Health and Social Care (DHSC) and the Devolved Administrations introduced these performance indicators in the Full Government Response to the O’Shaughnessy Review. These indicators are intended to drive progress towards our collective vision and maintain the UK's rich and varied clinical research portfolio, while achieving globally competitive set-up times for commercial contract studies by November 2024.
The indicators were developed in collaboration with the NHS, industry and medical research charities. Using data collected by the NIHR and the MHRA, the monthly report is produced by DHSC on behalf of the UK clinical research system. The report provides transparent updates on progress towards our goals over time.
News and Announcements
The following updates are from the dedicated partners who support the implementation of The Future of UK Clinical Research Delivery vision.
The government has announced nearly £50m of new funding to coordinate a network of dementia trial sites across the country.
NIHR has launched an annual competition for NHS trusts to buy research equipment.
A NewScientist podcast, supported by the MHRA and the Department for Business and Trade, went live on 14 February, featuring Lord O’Shaughnessy and promoting the UK as a prime destination for clinical trials.
Pharmaphorum covered the latest updates and positive progress seen in the NCVR programme, Inside the NCVR evolution in the UK.
The Pharmaceutical Journal published a piece on how pharmacists can play a notable role in more clinical research in primary care settings.
A research delivery pilot utilising pharmacists across multiple practices within Dudley was set up to support GP practices to deliver research and increase capacity and capability.
Nursing Times published a piece on why research is integral to developing the evidence base for practice.
An NIHR study showed that sites with the Associate Principal Investigator (PI) Scheme had over 3.5 times higher recruitment than those without. The scheme accepts both commercial and non-commercially funded studies which can be registered here.
Cancer Research UK has published the full findings from its 2023 Survey of the UK Clinical Research Workforce.
If you would like to submit an update to this monthly publication, please contact Emily Corcut, Senior Communications Manager at emily.corcut@nihr.ac.uk.