The predictive power of first recruits to commercial trial performance

The United Kingdom has a history of world-leading health research, showcased most recently in its response to the Covid pandemic. However, while the UK's performance in academic clinical research remains strong, its global position in the delivery of commercial research has declined. In 2023 Lord O'Shaughnessy reviewed the barriers and drivers to the delivery of commercial trials, identifying 27 recommendations to improve commercial trial performance. Highlighted within the report was the importance of the UK being globally competitive in the delivery of its trials, including study set up and approval times.

A dataset from the National Institute for Health and Care Research (NIHR), containing 28,188 site observations from 5,421 unique commercial studies provided data on first recruits to commercial studies spanning a 15-year period from 2010 to 2024. Where there were issues with data quality or reliability, data were cleaned, leaving 23,622 observations from 4,849 studies for analysis. Logistic regression and generalised linear mixed effects models were applied to determine whether sites that recruited their first participant to commercial studies more quickly had a higher probability of recruiting to time and target.

Sites that recruited their first participant more quickly were significantly more likely to recruit to time and target (RTT); (odds ratio per one-month increase in time 0.88, 95% CI 0.87 to 0.89, p < 0.0001). The model suggests that the predicted probability of RTT for a site falls to < 50% if it takes more than 8 months to recruit its first participant. A secondary analysis showed a highly significant increase in probability of a site meeting RTT if they recruited the 'first' Global, European or UK participants onto a study (odds ratio 2.96, 95% CI 2.20 to 4.05, p < 0.0001).

Sites that recruit first participants more quickly are more likely to recruit to time and target in commercial studies. This is likely to lead to them being selected by sponsors to participate in subsequent studies, increasing research opportunities for their patients and revenue for their organisation. Achieving quicker firsts requires proactive planning and coordination by R&D departments and study teams. Setting up sites in a timely manner is a key determinant of successful study delivery and a key component of the UK government's 10-Year Health Plan for England and Life Sciences Sector Plan.

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