Clinical trial site feasibility and enrollment support, led by a physician

Most feasibility exercises collect numbers rather than test them. A site is asked how many patients it can enroll each month, the answer is recorded, the answers are summed, and the total becomes the plan. Nothing in that process examines whether the estimate survives the protocol as written.

The cost of discovering the gap mid study is measured in months and amendments: additional site activations, extended timelines, protocol changes to eligibility criteria that should have been questioned earlier, and a randomization curve that has to be explained to a board. Clinical trial enrollment problems are rarely a surprise in hindsight. They are visible in the assumptions before the first patient is screened.

This work is therefore deliberately continuous. The same physician who interrogates the feasibility data before startup remains in contact with sites while screening experience accumulates, so expectations are revised against evidence rather than defended.

A site estimate is a claim, and a claim can be examined. The conversation moves from the number to the reasoning behind it: which clinic or unit the patients come from, how many of them were seen in the past year, how many would have met these eligibility criteria, who identifies them, and what happens to a candidate between identification and consent.

Where a site cannot describe that pathway, the estimate is not yet a projection. Where it can, the pathway itself usually indicates what would raise the number: a screening log run against records, a referral relationship with a colleague outside the research group, a coordinator hour protected for screening, or a change to a criterion that excludes patients for no scientific reason.

Testing the rationale behind site estimates and developing practical clinical trial recruitment strategies together produce more realistic and defensible enrollment projections. Defensible matters as much as realistic. A sponsor should be able to show a partner, a board, or an investor how the number was reached.

Peer to peer engagement with investigators builds the clinical rapport and commitment needed to address enrollment barriers and help sites prioritize a study within their research portfolios. Investigators are clinicians deciding how to spend limited research time. That decision responds to substantive medical conversation about the science, the population, and the patient in front of them.

A physician holding that conversation is doing something different from a monitor relaying a request. Eligibility questions can be resolved in the discussion. 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.

Medical oversight and patient recruitment in clinical trials remain grounded in participant safety, protocol compliance, and investigator judgment. Enrollment is never pursued at the expense of any of the three.