UK Clinical Research Delivery KPIs Show Gains in Trial Set-Up Speed but Persistent Gaps in Study Opening
核心洞察
The UK's latest Clinical Research Delivery KPIs show 100% of commercial contract CTIMP studies recruited a first participant within 150 days of regulatory application in January 2026, meeting the 95% target.
Combined review approval performance remained strong at 98% in April 2026, just below the 99% target, while study opening to recruitment lagged at 56% against a 90% target.
Average monthly recruitment to clinical studies reached 77,862 participants in the 12 months to May 2026, exceeding the pre-COVID-19 baseline of 69,200.
The UK's clinical research delivery system continues to make progress on end-to-end trial set-up speed, even as significant gaps persist in the time it takes for approved studies to open to recruitment, according to the latest UK Clinical Research Delivery (UKCRD) key performance indicators (KPIs) published by the National Institute for Health and Care Research (搜索) (NIHR) and the Medicines and Healthcare products Regulatory Agency (搜索) (MHRA).
The report, which brings together data predominantly from studies held on the NIHR Research Delivery Network (搜索)'s (RDN) Central Portfolio Management System (CPMS), measures trends in the speed and predictability of regulatory and study set-up times, delivery of research to time and target, and the volume of clinical research activity across the UK.
End-to-End Set-Up Speed Approaches the 150-Day Target
A new indicator introduced in April 2026 tracks the proportion of commercial contract clinical trial of investigational medicinal products (CTIMP) studies that recruit a first participant within 150 days of applying for regulatory approval. This measure aligns with the target set by the Prime Minister for cutting the time to set up a clinical trial in the UK to 150 days.
The latest data show that 100% of commercial contract interventional CTIMP studies with known status recruited a first participant within 150 days in both November 2025 and January 2026, exceeding the 95% target. Performance has improved markedly over the reporting period, rising from 62% in April 2025 to 100% by January 2026.
Analysis based on CPMS data alone, which enables comparison across financial years, shows a similar upward trajectory. The proportion of studies set up within 150 days rose from 45% in the April 2024 to September 2024 period to 73% in the April 2025 to September 2025 period. The median time from application to first participant recruited fell correspondingly, from 169 days to 122 days over the same comparison.
Combined Review Approval Remains Near Target
The combined review process, jointly conducted by the MHRA and a research ethics committee (REC), continued to perform strongly. In April 2026, 98% of approved studies received combined review approval within 60 days (or 90 days for advanced therapy investigational medicinal product, or ATIMP, studies), just below the 99% target.
Monthly performance has been consistently high, ranging from 96% in May 2025 to 100% in September 2025, November 2025, and March 2026.
Study Opening to Recruitment Lags Well Below Target
Despite strong regulatory review performance, the proportion of studies opening to recruitment within 60 days of Health Research Authority (HRA) approval remains a persistent challenge. In January 2026, only 56% of studies opened to recruitment within 60 days of regulatory approval, against a target of 90%.
Performance varied by study type, with commercial collaborative studies achieving 100%, non-commercial studies at 56%, and commercial contract studies at 51%. The longer-term trend shows limited improvement, with annual figures ranging from 30% in 2020 to 42% in 2025.
Similarly, the proportion of studies recruiting a first participant within 30 days of opening to recruitment stood at 61% in January 2026, against a 90% target. The report notes that since 2017, this indicator has been consistently below the 90% target, and the average number of days taken to recruit a first participant has remained consistently higher than 30 days.
Recruitment Delivery and Volume
The proportion of open studies delivering recruitment to time and target held steady at 82% in July 2026, above the 80% target. This reflects a sustained improvement since July 2023, when the system began regularly meeting or exceeding the target. Commercial contract studies performed slightly below the overall figure at 78%, while non-commercial studies led at 83%.
Average monthly recruitment to clinical studies reached 77,862 participants over the 12 months to May 2026, exceeding the pre-COVID-19 baseline of 69,200 participants. Non-commercial studies accounted for the majority of recruitment at 68,886 participants per month, compared with 3,758 for commercial contract studies and 5,219 for commercial collaborative studies.
The report notes that participation in commercial contract studies increased significantly in 2023 and 2024, primarily due to increased recruitment to several very large observational studies, before moderating in 2025.
New Study Volume
In June 2026, 181 new studies were added to the CPMS portfolio, comprising 84 commercial contract studies, 15 commercial collaborative studies, and 82 non-commercial studies. Since 2016, approximately one-third of new studies added to the CPMS have been commercial contract studies.
The report cautions that the data measures performance of a specific subset of studies in the UK, predominantly those on the CPMS, and does not capture the performance of the entire clinical research system. Users are encouraged to focus on longer-term trends over six or 12 months for a more accurate view of system performance, as short-term fluctuations are not always reliable indicators of change.