Ounce of Prevention
An ounce of prevention: clinical trial site feasibility before startup
Enrollment that falls short of predictions and established study timelines is closely linked to unverified site enrollment projections, and not having a finger on the pulse of site capabilities and changes. DF Clinical works hand in hand integrating with your clinical startup team to interrogate enrollment assumptions, build relationships with clinical site investigators and personnel, and flush out blind spots at the outset of the study. The goal is to complement your study team by helping the Sponsor make more informed site selection decisions, informing a more accurately prediction of the number of sites required to meet enrollment timelines.
The Problem
Feasibility collects numbers. It rarely tests them.
A site is asked how many patients it can enroll each month. The answer is recorded. The answers are summed. The total becomes the plan and the timeline, and the timeline is presented to a board. Nothing in that sequence asks whether the estimate survives the protocol as written.
The cost of finding out later is measured in months, amendments, and additional site activations. Eligibility criteria are loosened to rescue a projection that should have been questioned before startup, and the study loses the population it was designed around. Clinical trial enrollment problems are rarely a surprise in hindsight. They are visible in the assumptions.
During Startup
Inspiring investigators
DF Clinical firstly engages the investigator on a video call or site visit as soon as the feasibility questionnaire is returned. This critical activity is much easier to perform at the very beginning of the study and helps set expectations of ongoing peer-to-peer engagement that fosters accountability. At this time the background of the therapy being tested and mechanism of action can be emphasized with the investigator. This is an important opportunity to evaluate whether the investigator believes enough in the indication and potential therapy, and has enough personal and departmental bandwidth to drive enrollment at the site. Investigator interaction at this time informs an assessment of how the site is likely to perform over the course of the study. Other key inputs to this assessment are protocol eligibility criteria as a filter, staff availability, competing studies, referral pathways, and advertisement opportunities.
Prevention costs less than a remediation plan.
Bring the protocol, the draft site list, and the projections you have been given. DF Clinical is based in Cary, North Carolina and works with sponsors and CROs across the globe.