Clinical trials are powered by people: patients who volunteer, and site teams who sustain them. Yet the modern trial increasingly asks both groups to absorb rising complexity with shrinking time.
Nearly half of healthcare workers reported symptoms of burnout in 2022, according to the CDC’s national survey of healthcare workers. At the same time, 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.
Retention is the hidden variable in enrollment
Attrition rates vary across therapeutic areas and study designs, but systematic analyses show dropout commonly ranges between 10 and 30 percent in randomized controlled trials. Even modest improvements in retention can materially reduce recruitment pressure, shorten timelines, and decrease costs.
Instead, sponsors frequently respond to attrition by inflating enrollment targets and adding more site workload. That strategy increases site workload without addressing the underlying causes of disengagement: operational design.
Complexity has increased faster than capacity
Over the past decade, protocol complexity has grown steadily. Research from Tufts Center for the Study of Drug Development shows substantial increases in the number of endpoints, procedures, and data points collected per protocol, particularly in late-stage trials. Additional analyses published in Therapeutic Innovation and Regulatory Science show that increasing protocol burden is associated with longer cycle times, more amendments, and poorer operational performance.
Every incremental addition to a protocol, like another endpoint or visit, takes time away from a workforce that’s already stretched thin. And that time comes directly out of patient-facing work. Site teams spend more time on administrative work and less time with patients, causing them to disengage. Dropout rises, recruitment targets get harder to hit, and the pressure to do more with less only grows.
Burnout in healthcare is not theoretical. Clinical research coordinators operate within the same strained workforce environment as the rest of healthcare, often managing complex studies with limited support. Experienced clinical research professionals remain in limited supply, and workforce expansion alone can’t keep pace with growing complexity. If capacity can’t expand to match demand, the burden has to be reduced intentionally.
Design discipline as a retention strategy
A Tufts study found that a third of the data we collect in late-stage trials is unnecessary. These additions accumulate over time, often without anyone stepping back to reassess whether they’re still necessary, and each one adds operational friction for sites and patients alike.
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.
Enrollment is not just about access
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. When trials respect the time and capacity of site teams, retention becomes more durable, performance more predictable, and trials succeed.
Photo: Deidre Blackman, Getty Images
Scott Chetham Ph.D. is an experienced healthcare entrepreneur who is currently the CEO and co-founder of Faro Health. Scott leads the strategy for the Faro Health platform, which is designed to power clinical development by connecting data to decision making in a fundamentally new way. Previously, he was the Head of Clinical Research Operations and Data Management at Verily Life Sciences, formerly known as Google Life Sciences. This multi-faceted strategic and operational role involved leading the clinical strategy, clinical teams, process development and operations for all clinical projects of the company, including Google and Google[x]. Scott has also served as a Venture Partner at Versant Ventures, CTO and Co-founder of Intersection Medical (sold to ImpediMed), and VP Clinical Affairs (ImpediMed). In these latter two roles he was responsible for clinical research strategy and operations.
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