UK publishes clinical trial performance data: 82% of studies already open are recruiting to plan, but post-approval study initiation is lagging

UK publishes clinical trial performance data: 82% of studies already open are recruiting to plan, but post-approval study initiation is lagging

On 19 August, the UK Department of Health and Social Care published the July performance data for the UK Clinical Research Delivery (UKCRD) programme, which tracks clinical trial timelines. The programme measures each stage from application submission to enrolment of the first participant separately.

Before patient recruitment begins, a clinical trial passes through several stages. First, the regulator and the ethics committee approve the protocol. Research sites then open recruitment, after which the first participant is enrolled. UKCRD measures each of these transitions separately. The 82% figure describes recruitment in studies that are already open. Separate indicators measure study initiation after approval.

In July, the Central Portfolio Management System (CPMS), the database used by the UK National Institute for Health and Care Research network, contained 4 347 open studies. In 82% of them, recruitment was proceeding to plan and meeting the target number of participants. The target for this indicator is 80%.

The decline in recruitment predates the current report. An independent review published in 2023 found that participation in commercial studies supported by the National Institute for Health and Care Research fell from approximately 50 thousand participants per year in 2017–2018 to 28 thousand in 2021–2022. UKCRD has published these indicators since 2024.

For commercial drug trials, the 150-day indicator covers the full period from application submission to enrolment of the first participant. All nine studies submitted in January met this deadline. The report tracks two further stages after approval. Of 98 studies, 55, or 56%, opened for recruitment within 60 days. Of 57 studies, 35, or 61%, enrolled their first participant within 30 days after recruitment opened. The target for each stage is 90%.

The figures of 82%, 56%, and 61% refer to different stages of a clinical trial. Taken together, they show where delays occur between approval and enrolment of the first participant.

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