UK clinical
research update
May 2025 edition
Published May 27, 2025
Highlights
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.
- The Department for Science Innovation and Technology has unveiled plans to support long-term, ten-year funding for certain R&D activities. The changes will provide long-term certainty to researchers and industry, deepening opportunities for partnerships in vital R&D work that could transform the UK economy. The introduction of guidance meets key manifesto commitments, supporting the government’s upcoming Industrial Strategy and delivering growth as part of the Plan for Change.
- MHRA highlights “remarkable” progress and launches real-world data consultation on International Clinical Trials Day.
Study Set-Up Plan Update
This portion of the UK Clinical Research Update is dedicated to the UKCRD Study Set-Up Plan. In April 2025, the Department of Health and Social Care (DHSC) on behalf of the four UK nations, published a policy statement announcing the new Study Set-Up Plan, to rapidly address the delays affecting clinical research through digitalisation and reducing unnecessary bureaucracy.
As a part of this work, commercial agreements for participating NHS and Health and Social Care (HSC) organisations have now been updated by the Four Nations Contracts Leads following feedback from commercial sponsors, Clinical Research Organisations (CROs) and NHS Trusts. This is a crucial first step in delivering phase 2 of the Study Set-Up Plan.
HRA has made some changes to these agreements to make it easier to reflect National Contract Value Review (NCVR) negotiated and non-NCVR negotiated financial arrangements.
You can learn more about the Study Set-Up Plan by viewing the ‘Streamlining and reform of study set-up’ webinar. Following the original airing of this webinar in April, there has been a huge amount of engagement. UKCRD delivery partners involved with the Study Set-Up Plan thanks everyone for their thoughtful questions and contributions. The team is currently reviewing hundreds of questions and will be developing a comprehensive Q&A which will be shared in the next UK Clinical Research Update and at ukcrd.org.
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 | April 2025 | ||
|---|---|---|---|---|---|---|---|
| 1 | All³ | Proportion of studies receiving combined regulatory review achieved within 60 days | 99% | Maintain target | 🟡 | 100% | 98% |
| 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% | 11%⁵ |
| 3 | C | Proportion of studies recruiting first participant within 30 days of sites opening to recruitment | 90% | November 2024 | 🔴 | 25% | 29%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% | 84%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 | 92,821⁹ |
| 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 | 7,016⁹ |
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.
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.
- As part of the Health Research Authority’s (HRA) vision for research transparency, they have published the Clinical trial registration report 2023.
- NIHR Research Delivery Network announces new integrated ways of working. These changes will enable more types of research to take part in a wider range of health settings.
- The NIHR’s Scoping Locations for Research (self service) tool has been updated. As well as viewing prevalence data from across the UK, you can now view UK-wide ethnicity and deprivation data.
- NIHR recently hosted a webinar, ‘Strategies for growing patient recruitment and retention through inclusive research design and delivery.’ In this webinar, expert panellists explored how inclusive and accessible approaches to trial design and delivery can expand your patient demographic, improve retention rates and speed up recruitment. Watch the webinar recording here.
- NIHR’s Associate Principal Investigator (PI) Scheme has sparked interest in the commercial world. Global pharma companies are boosting recruitment to trials while helping to build research capacity and capability in the UK. Read the case study or register for the webinar to learn more.
- Samantha Jones has been appointed as the new Permanent Secretary at the Department of Health and Social Care and will start from 16th June 2025.
- World-first trial launched for fridge-free vaccine. UK-based biotech company Stablepharma has developed a novel technology with support from a UK government-backed programme. Their platform converts existing approved vaccines to fridge-free versions that are ‘thermostable’ and can be stored for long periods of time at room temperature.
If you would like to submit an update to this monthly publication, please email UKCRDprogramme@dhsc.gov.uk