| The problem
Most clinical trials fail to meet their original enrollment timelines. Analyses of trial performance have consistently shown that approximately 80 percent of studies miss planned recruitment targets or timelines. These are often treated as separate operational problems, but they’re intrinsically linked. When coordinators are buried in documentation, scheduling, and data reconciliation, patient engagement is the first thing to go. And when engagement drops, retention drops with it. Behind every delayed trial is a site team operating at capacity, and behind every patient who drops out is a moment when support could have made the difference. How to improve
Trials designed with clearer endpoint alignment and reduced unnecessary burden demonstrate stronger operational performance, including improved recruitment efficiency and fewer amendments. Efforts such as the Clinical Trials Transformation Initiative’s Quality by Design framework emphasize aligning procedures tightly with study objectives and feasibility considerations. Better optimized trials can easily improve retention without sacrificing scientific rigor. It just requires clarity about which data are essential, which procedures drive outcomes, and which requirements add noise without advancing objectives. Alignment matters
Industry conversations about enrollment often focus on expanding eligibility criteria, increasing diversity, or incorporating decentralized trial elements. Those strategies matter, but enrollment doesn’t end at consent. Whether patients stay depends on what happens after they enroll, an experience shaped by both protocol design, and the capacity of the site teams to provide consistent support. Clinical trials succeed when science and operations are aligned. — By MedCity Influencer Scott Chetham |
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