Why patient recruitment is the number one reason clinical trials run late and what actually works

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Why patient recruitment is the number one reason clinical trials run late and what actually works

Patient recruitment is not a footnote in clinical trial delays, it is usually the major cause. A systematic review and meta-analysis of patient recruitment found that around 80% of trials fail to meet their initial enrolment target and timeline, with recruitment named as the single biggest cause of delay (Brøgger-Mikkelsen et al., 2020). That is not unique to the UK, but the UK’s own data tells much the same story.

 

What the UK data shows

UK government data tells much the same story. Only 40% of commercial contract trials recruit their first participant within 30 days of opening to recruitment, against a target of 90% (Department of Health and Social Care, 2026). A separate analysis of NIHR data looked at nearly 30,000 site observations across 4,849 studies over 15 years, and found something more specific: sites that recruit their first participant within eight months are far more likely to hit their overall target. Beyond eight months, the odds drop below 50% (Batty et al., 2026, as reported by Oxford Health NHS Foundation Trust).

 

Why this is an execution problem, not a demand problem

Recruitment failure, in other words, is rarely a demand problem. It is an execution problem, decided in the earliest weeks of a study. That distinction matters, because it shows where the real fix needs to happen. Sites rarely lack protocols to run. What they lack is a fast, low-friction way to identify, reach and enrol eligible participants once a study opens. Every extra week spent chasing referrals through the usual channels, or manually screening against inclusion criteria, is a week added to a timeline that was already tight.

 

The NHS’s own response

The NHS itself is responding to this at a structural level. Its 10 Year Health Plan sets out a shift of care and research closer to communities, through new Neighbourhood Health Teams and the integration of ‘Be Part of Research’ into the NHS App. The aim is for patients to be matched to relevant studies and notified directly, rather than relying on a chance conversation with a clinician (Department of Health and Social Care, 2025). It comes down to a simple recognition: recruitment happens in a patient’s everyday life, not in a trial site’s paperwork. Closing that gap is central to the plan’s own 150-day trial set-up target.

 

What actually works

For research teams, the practical question is how to bring that same logic into their own studies now, without waiting for national infrastructure to catch up. Self-registration that doesn't need a site visit. Screening against inclusion criteria that runs automatically rather than by hand. Consent a participant can complete from home rather than in a waiting room. And once someone is enrolled, keeping them engaged through questionnaires they can fill in remotely, rather than losing them to a missed follow-up visit. All of it shortens that critical early window, and helps keep participants in the study once they've joined.

These are exactly the kind of components ResearchManager’s Patient Recruitment, eConsent and ePRO tools support, and they’ve been explored across European trials by sponsors and CROs working through the same recruitment pressure. We’d be glad to talk through what that could look like for research teams here in the UK.

Get in touch with us at hans@myresearchmanager.com or visit https://my-researchmanager.com/en/ 

 


References

Batty, M., et al. (2026). The predictive power of first recruits to commercial trial performance. BMC Medical Research Methodology.https://link.springer.com/article/10.1186/s12874-026-02907-z

Brøgger-Mikkelsen, M., Ali, Z., Zibert, J. R., Andersen, A. D., & Thomsen, S. F. (2020). Online patient recruitment in clinical trials: Systematic review and meta-analysis. Journal of Medical Internet Research, 22(11), e22179. https://doi.org/10.2196/22179

Department of Health and Social Care. (2025). Fit for the future: The 10 year health plan for England (CP 1350). https://www.gov.uk/government/publications/10-year-health-plan-for-england-fit-for-the-future

Department of Health and Social Care. (2026). UK Clinical Research Delivery key performance indicators: data to February 2026. https://www.gov.uk/government/statistics/uk-clinical-research-delivery-key-performance-indicators-data-to-february-2026/uk-clinical-research-delivery-key-performance-indicators-data-to-february-2026

Oxford Health NHS Foundation Trust. (2026, July 1). New study highlights importance of early recruitment in clinical trials. https://oxfordhealth.nhs.uk/news/new-study-highlights-importance-of-early-recruitment-in-clinical-trials/