A Site With Persistent Under-Enrollment and a Disengaged PI
Site 207 has a 12-month enrollment target of 24 subjects in a Phase III cardiovascular outcomes study. After 9 months, it has enrolled 3. The principal investigator is the department chair and attends site initiation but has not reviewed the prescreening log in four months. A new CRC took over six weeks ago after the previous coordinator left; the new CRC received no study-specific training. The prescreening log shows 41 patients approached, 6 eligible, and 3 enrolled. Common reasons for exclusion are washout-period conflicts, lab draws scheduled outside the protocol window, and no weekend capacity for sample processing. A competing industry trial opened in the same department two months ago and pays a higher per-visit administrative fee. The sponsor's clinical lead emails you: 'Please motivate the site-we need enrollment up by next month.' The site says it is 'doing its best' and asks for additional financial support. You have one scheduled on-site visit in two weeks.
1. What root causes would you investigate, and what data would you gather before proposing an action plan?
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The causes are likely multifactorial: PI disengagement from enrollment oversight, a new CRC without study-specific training, prescreening that does not identify washout and lab-window barriers early, no weekend processing capacity, and competition from a trial with higher per-visit payment. The funnel is informative: 41 approached and 6 eligible is a 15% eligibility rate, which may reflect poor prescreening or a restrictive protocol; 3 enrolled from 6 eligible suggests further losses at consent or randomization. Gather screening logs with reasons, time from approach to consent, lab-window deviations, staff availability, the competing trial's start date, and evidence of PI eligibility review. Also check whether the site has the right patient population and whether the protocol's visit schedule is feasible for this clinic. Do not accept 'motivate the site' as an action; define the specific funnel problem first.
2. How would you communicate with the PI, the CRC, and the sponsor?
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Speak with the PI first, not only the CRC. Use a short agenda: the enrollment gap, funnel data, delegated authority, and site capacity. Ask the PI to name a co-investigator or sub-investigator for enrollment and to review the prescreening log monthly. Meet the CRC to identify training gaps and simplify prescreening. With the sponsor, reframe the request: provide a feasible enrollment plan with milestones, such as two subjects per month, rather than a vague motivation request. Discuss whether additional financial support is appropriate; higher per-visit payment may not fix weekend capacity or washout conflicts. Document commitments and send a confirmatory email to the PI and sponsor. Avoid promising enrollment the site cannot deliver, and keep the tone collaborative but factual.
3. What measurable remediation and escalation steps would you recommend if enrollment does not improve?
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Set measurable milestones: by week 2, the CRC is trained and the delegation log is updated; by week 4, the PI reviews 100% of prescreening logs; by week 8, at least two additional subjects are enrolled and all screen failures have documented reasons. If there is no improvement by week 12, escalate to the sponsor for an enrollment remediation plan, possible protocol amendment, or site replacement under the contract. Use a formal action letter if needed. Monitor data quality as well as numbers, because rushed enrollment can create eligibility and consent problems. The CRA's role is to identify barriers, facilitate solutions, and escalate objectively; it is not to enroll patients or pressure the site into unsuitable candidates.