Enrolment is the single most common reason clinical trials run late. The causes are rarely mysterious: optimistic assumptions about how many eligible patients a site actually sees, eligibility criteria that look sensible on paper but exclude most real-world patients, and sites that are activated on reputation rather than evidence.
Start with the patients, not the sites
Traditional feasibility asks investigators how many patients they expect to enrol. Self-reported estimates are consistently higher than what is achieved. A data-led approach starts from the patient population: where eligible patients are treated, how they are referred and what they need in order to participate.
Stress-test the protocol early
Before a protocol is finalised, apply its inclusion and exclusion criteria to realistic patient profiles. A criterion that removes a large share of candidates for a small scientific gain is a candidate for discussion with the sponsor's clinical team.
Monitor enrolment as a live signal
Enrolment should be tracked weekly by site, with agreed triggers for action: additional outreach, support for a slow site, or opening a new centre. The earlier a gap is visible, the cheaper it is to close.
How we approach it
Our patient recruitment software supports each of these steps, from identifying promising centres to tracking referral pipelines in real time. Learn more about our recruitment platform.
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