UK clinical
research update
September 2025 edition
Published September 29, 2025
Highlights
This monthly update summarises recent news, announcements, guidance, and updates on progress made to propel the aims of the UK Clinical Research Delivery (UKCRD) programme of work. As such, this update provides examples of how organisations individually and collaboratively are achieving the collective goal of making the UK a world leader in clinical trials.
- The National Institute for Health and Care Research (NIHR) has awarded £6.5 million, funded jointly through a public-private partnership with the pharmaceutical industry, to establish a UK-wide Commercial Research Delivery Centre (CRDC) Network. The network will be hosted by University Hospitals of Leicester NHS Trust (UHL), and commences formally on 1 September 2025.
- The new network will provide strategic coordination of all 21 CRDCs across the four nations of the UK. It will play a key role in building research capacity, streamlining the interface between industry and the UK clinical trials delivery infrastructure, and enhancing efficiency to deliver commercial clinical research through harmonised processes, in line with the Prime Minister’s call earlier this year to turbocharge medical research.
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 developing a faster, more efficient and more innovative clinical research delivery system.
The indicators were developed in collaboration with the NHS, industry and medical research charities. Using data collected by the NIHR and the Medicines and Healthcare products Regulatory Agency (MHRA), the monthly report is produced by the Department of Health and Social Care (DHSC) on behalf of the UK clinical research system. The report provides transparent updates on progress towards our goals over time.
The following is a snapshot of the full UK Clinical Research Delivery Performance Indicators Report. Click here to read the full report.
| UK Performance Indicator | Target | Timeline for delivery | Trend | Baseline² | August 2025 | ||
|---|---|---|---|---|---|---|---|
| 1 | All³ | Proportion of studies receiving combined regulatory review achieved within 60 days | 99% | Maintain target | 🟡 | 100% | 97% |
| 2 | C⁴ | Proportion of studies open to recruitment within 60 days of HRA approval letter or equivalent process used by the Devolved Administrations | 90% | November 2024 | 🔴 | 39% | 15%⁵ |
| 3 | C | Proportion of studies recruiting first participant within 30 days of sites opening to recruitment | 90% | November 2024 | 🔴 | 25% | 17%⁵ |
| 4 | C | Proportion of NHS trusts in England that accept the NCVR process for late-phase studies | 100% | December 2023 | 🟢 | 79% | 100% |
| 5 | All | Proportion of open studies on track, delivering to time and target | 80% | June 2023 | 🟢 | 80% | 83%⁶ |
| 6 | All | Recruitment to studies is maintained compared to the pre-pandemic baseline (61,000)⁷ ⁸ | 70,000 or more per month⁹ | Ongoing | 🟢 | 70,000 | 85,011⁹ |
| 7 | C | Recruitment to all commercial studies to be monitored in support of the ambition to double and double again from the pre-pandemic baseline of 3,200⁷ ⁸ | Reported per month⁹ | Ongoing | 🟡 | 3,200 | 3,836⁹ |
2 Some measures are new and therefore the baseline was established in different months.
3 All indicates a measure that applies to all studies.
4 ‘C’ indicates that it applies to commercial contract studies only.
5 There is a latency or lag between activity and data being recorded in the central system. This means that the data for these indicators for most recent months is often incomplete and low. The data are updated retrospectively, taking six months or more for the datasets to be fully consolidated.
6 Based on recruitment in England and England target.
7 Average per month in England only from 2015 to 2020.
8 Data on trial phase to be provided subsequent to implementation of digital infrastructure.
9 Rolling average across the previous 12 months.
Trust Level Set-Up Report
One of the deliverables of the Study Set-Up Plan, a UKCRD programme of work aimed at streamlining and reforming the set-up and delivery of clinical trials, is to provide an additional monthly snapshot of site-level commercial study set-up performance. The aim of this report is to take initial steps in improving the granularity of study set-up activity to support closer to real time monitoring of system performance.
You can find the latest report here: Trust Level Set-Up Report
News and Announcements
The following updates are from the dedicated partners who support the the development of a faster, more efficient and more innovative clinical research delivery system.
MHRA launches Route B notification pilot as part of clinical trials regulations rollout. The pilot will help sponsors prepare for a new substantial modifications process under upcoming regulations, with responses delivered within 14 days.
A new report, commissioned by the Association of Medical Research Charities (AMRC) and Wellcome, has found that clinical research funded by charities and the public sector contributed £72.7b to the UK economy (2014-2024). The analysis, carried out by Frontier Economics, reveals the ‘triple dividend’ this type of research brings to the UK: unlocking growth, supporting the NHS and improving lives.
Earlier this year, the Health Research Authority (HRA) asked people working across health and social care research about their experience of study set-up at sites in the UK. They received more than 500 responses, and the results are now available on their website. The results will help HRA to create a baseline to measure the impact of the improvements they are making to speed up the study set-up process, as part of the UKCRD programme.
The HRA have published the findings of a survey they ran earlier this year to gather feedback on simplifying arrangements for the consent process in certain clinical trials. This is part of the work they are doing to support the updated clinical trials regulations, coming into force on 28 April 2026.
Newcastle University has been awarded a further £22 million by the NIHR to continue its research to identify emerging medicines, diagnostics, devices and digital technologies that have the potential to transform care, reduce inequalities and support a more responsive and resilient system. This 5-year award underpins the work of the world-leading NIHR Innovation Observatory.
Health and Care Research Wales launched a new three-year action plan to increase diversity and inclusion which aims to further widen the reach of research opportunities to more communities.
Save the date for a HRA webinar on research transparency and share results with participants. The webinar is for researchers and sponsors and will be held on 2 October.
Northern Ireland (NI) will be hosting its premiere annual health and social care conference, bringing together health and social care leaders and partners to secure better outcomes for all in NI, on 15-16 October 2025.
Health and Care Research Wales is hosting its annual conference, celebrating 10 years of impact, on 16 October 2025. All in-person spaces are sold out, but you can join the waiting list or view the conference online.
NIHR is hosting a webinar Supercharge your feasibility, site identification and site selection, on 22 October. In this webinar, you will learn how you can leverage data by using the recently enhanced NIHR Scoping Locations for Research tool and their Site Identification Service when planning your trial. The panel will explore how the latest developments can accelerate study set-up, enhance recruitment and widen access to research across the UK.
NHS Research Scotland has announced its leading research and innovation conference with prizes awarded to best presentations. The conference will be taking place on 23 October 2025.
If you would like to submit an update to this monthly publication, please email UKCRDprogramme@dhsc.gov.uk