Enrollment Rescue
Enrollment rescue for delayed clinical trials
When enrollment falls below projection, it is critical to identify the reasons for the lagging enrollment, and the best opportunities to remediate and get back on track. DF Clinical works directly with investigators and site teams to find what is limiting enrollment, builds a prioritized plan, and stays with the sponsor and CRO through implementation.
01 · When should you call?
Signs that a study needs outside medical attention
- Enrollment is behind plan and the gap is widening rather than closing.
- Site explanations remain vague: the patients are "coming," the referrals are "in process," and nothing specific changes from one call to the next.
- Screening is low, so the problem sits before eligibility, not inside it.
- Repeated recruitment initiatives, such as new materials, advertising, or added sites, have not resolved the problem.
Any one of these is reason to look closer. Two or more usually means the cause has not yet been identified.
02 · What do we investigate?
Every place a patient can be lost before randomization
- Patient pathways: where eligible patients are actually seen within the institution, and whether the study team ever meets them.
- Protocol defined eligibility: which criteria are failing, at which sites, and whether the failures are clinical or procedural.
- Investigator engagement: whether the investigator believes in the indication and has the bandwidth to drive enrollment.
- Competing studies that draw on the same population or the same staff.
- Referral processes from clinics, departments, and outside physicians.
- Staffing, scheduling, and other site constraints that limit how many patients can be screened.
03 · What do we do?
Physician to physician work at the site level
- Engage investigators and coordinators directly, by video call or site visit, in a substantive medical conversation about the study and the patients in front of them.
- Distinguish clinical barriers, such as eligibility criteria or assessment burden, from operational barriers, such as staffing, referrals, or scheduling.
- Develop a prioritized intervention: the few changes most likely to move enrollment, in the order they should happen.
04 · What does the sponsor receive?
A clear picture and a plan to act on
- Site assessments describing what is limiting enrollment at each site reviewed.
- Site specific action plans with defined steps.
- Recommendations for resource allocation: where to invest effort, which sites to support, and where additional sites may be needed.
- An updated enrollment outlook grounded in what the sites can realistically deliver.
05 · How do we follow through?
Implementation, not just recommendations
- Assign an owner to every action, whether at the sponsor, the CRO, or the site.
- Track implementation against the plan.
- Escalate unresolved decisions to the sponsor so they do not stall at the site level.
- Measure changes in screening and enrollment, and adjust the plan based on what the numbers show.
The Problem
The curve reports the problem months after it formed
An enrollment report shows that a site is behind, and three months have passed since the SIV. Information that might have informed earlier action may be a specific eligibility criterion that keeps failing, an investigator who stopped returning calls, or a competing study that took precedence when the site's calendar filled.
By the time the gap is visible in the randomization curve, the options are narrower. Additional sites are activated, the timeline extends, and eligibility criteria are revised to rescue a projection that was never realistic. The remediation that follows costs more than the diagnosis that should have preceded it.
Acceleration
Where acceleration is possible
Dr. Fineberg directed enrollment acceleration strategies for a highly enriched septic shock trial, conducted medical monitoring site visits to support protocol compliance and enrollment, and led development of enrollment technologies including electronic medical record based alerts and electronic investigator workflows on a global Phase 3 program of approximately 800 patients across 159 sites in 25 countries.
Peer to peer engagement with investigators is part of the same work. Investigators are clinicians deciding how to spend limited research time, and that decision responds to substantive medical conversation about the science, the population, and the patient in front of them.
Eligibility questions can be resolved inside that conversation. Concerns about the assessment schedule can be answered with the reasoning behind it. Where the investigator is right and the protocol is the obstacle, that can be said and carried back to the sponsor.
Bring the projection and the actual.
Bring the enrollment projection, the randomization to date, and the site list. DF Clinical is based in Cary, North Carolina and works with sponsors and CROs across the globe.