Pound of Cure
A pound of cure: enrollment remediation while the study is running
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 diagnoses underperforming sites, engages investigators directly, and puts a remediation plan in place with updated projections.
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.