UK clinical
research update
August 2025 edition
Published August 27, 2025
Highlights
- The Department of Health and Social Care (DHSC) has published an update on progress the government has made to implement the Lord O’Shaughnessy review of commercial clinical trials and how it is going further and faster beyond the review to transform the UK clinical research system.
- The Health Research Authority (HRA) has responded to this update with Dr Janet Messer, Director of Approvals Service stating, “We are supporting the government’s plan through our work as part of the cross-sector UK Clinical Research Delivery programme, which aims to streamline and reform the delivery of clinical trials.”
- Following the completion of the Study Set-Up Plan in June 2025, UKCRD will be hosting a webinar on 23rd September at 14:00 BST, ‘Study Set-Up Plan update: Progress and next steps.’ The discussion will offer reflections from delivery partners and the devolved nations on what’s been achieved and provide an update on the necessary next steps to achieve the Government’s target of reducing clinical trial set-up time to a maximum of 150 days by March 2026. This webinar serves as a continuation of the ‘Streamlining and reform of study set-up’ webinar, which originally aired on 2 April 2025.
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.
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.
| UK Performance Indicator | Target | Timeline for delivery | Trend | Baseline² | July 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% | 24%⁵ |
| 3 | C | Proportion of studies recruiting first participant within 30 days of sites opening to recruitment | 90% | November 2024 | 🔴 | 25% | 11%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 | 87,122⁹ |
| 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 | 4,201⁹ |
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.
- NIHR and research funders’ joint commitment for better inclusion of older adults in research and health studies
- HRA has published the findings of a survey that 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’re doing to support updated clinical trials regulations coming into force in the UK on 28 April 2026.
- The MHRA has published their 2024–25 Annual Report and Accounts and Impact Report showing progress on safety, innovation, and regulatory excellence.
- In a new policy statement, the MHRA outlines intent to speed up patient access to innovative medical devices. The statement sets out initial thinking on a new Early Access service to help patients benefit sooner from innovative medical devices that address unmet clinical needs.
- The commercial model agreements for use with participating NHS and HSC organisations have been updated to align with the model Commercial Chief Investigator Agreements published in June 2025. On Wednesday 30 July HRA issued a HRA Now email explaining what commercial sponsors, contract research organisations (CROs), NHS and HSC organisations need to be aware of.
- MHRA has been designated as a WHO-Listed Authority, a milestone for UK life sciences and global health. WHO recognition affirms MHRA’s commitment to regulatory excellence, innovation and global collaboration
- Patients in England with advanced head and neck cancer are now being fast-tracked into a pioneering clinical trial for an investigational mRNA cancer vaccine, supported by the NIHR and the NHS’s expanding Cancer Vaccine Launch Pad. This is a UK-wide study with patients being recruited from across the country.
If you would like to submit an update to this monthly publication, please email UKCRDprogramme@dhsc.gov.uk