How to Secure Patient Recruitment in a Clinical Trial

Patient recruitment is one of the main reasons clinical trial timelines slip. According to CTTI, more than 80% of studies fail to meet their enrollment targets within the planned timeframe.

That figure hides a more precise reality: the protocol is not always the culprit. How recruitment is prepared, activated, and managed is what makes the difference. For sponsors, biotechs, and CROs, acting before the first site opens is essential.

Understanding the real causes of poor clinical trial recruitment

Stalled recruitment is never the result of a single cause. Experienced teams distinguish three levels of failure.

The first is structural: overly restrictive eligibility criteria shrink the pool of eligible patients. This can be detected at the feasibility stage, provided site selection is conducted rigorously.

The second is organizational: sites overestimate their enrollment capacity. The investigator counts a theoretical number of patients without accounting for absences or consent refusals. The gap between projection and reality widens within the first few weeks.

The third is operational: insufficient on-site follow-up at activation. When a CRA is not available for the first enrollments, protocol deviations appear and investigators disengage.

Site activation: the most critical moment

Site activation covers the period between the green light to start and the first patient enrolled. This is where the working habits of the entire study are set. A well-activated site will recruit. A poorly activated site will undermine its targets from the outset.

Several concrete actions secure this phase. Staff training must focus on eligibility criteria and the consent process. Data collection logistics must be tested before the first real visit. Access to systems (eCRF, ePRO) must be verified in advance.

The CRA plays a central role here. Their presence at activation reduces protocol errors. They identify blockers, clarify misunderstandings in real time, and build trust with the clinical staff. That relationship is valuable throughout the entire recruitment period.

Need on-site support for your site activations? Our Keena Life Sciences team is available to discuss your CRA needs.

Managing recruitment in real time: the indicators to track

Securing recruitment requires continuous monitoring built around precise indicators. A recruitment strategy for a clinical study does not stop at site activation.

The weekly enrollment rate per site is the baseline indicator. It must be compared with the forecast established during feasibility. A gap that persists for two weeks should trigger an immediate corrective action, not just a reminder.

The screen failure rate deserves particular attention. A high number of patients screened but not enrolled reveals a misunderstanding of the eligibility criteria. It is an operational signal, not a statistical one.

The time between randomization and the first follow-up visit measures organizational fluidity. When that delay lengthens, the risk of losing patients during recruitment increases.

When should you outsource CRAs to improve recruitment?

Internal teams cannot always absorb the activity peaks that come with several sites opening at once. When in-house CRAs are stretched across multiple studies, timelines slip and recruitment suffers.

When recruitment is struggling, bringing in outsourced CRAs strengthens on-site presence. It avoids overloading permanent teams and preserves the quality of monitoring.

The condition is simple: the external CRA must be briefed quickly and integrated into the sponsor's tools. They should be supported during their first visits. The more structured the onboarding, the faster the impact.

Keena Life Sciences provides qualified CRAs who can be deployed for activation phases or monitoring reinforcement. Their command of the protocol is verified before each assignment.

Securing recruitment is not just about opening more sites. It means anticipating failure points from feasibility, taking care of every activation, and reinforcing teams at the right time.

A well-positioned, well-briefed CRA is the leading success factor of a robust recruitment strategy. Teams that anticipate these levers meet their enrollment targets, even in the most complex studies.