Nearly 6 in 10 clinical trial sites are losing eligible patients before they ever enroll, not because those patients don’t exist, but because the machinery around finding and qualifying them is broken. A new survey puts the figure at 59% of sites reporting that process inefficiencies are directly suppressing recruitment, and that number deserves more attention than it typically gets. The instinct in this industry is to treat recruitment shortfalls as a supply problem, a thin patient population or a narrow protocol. The survey reframes it as a throughput problem, which is a materially different challenge with different solutions.
The context here matters. Tufts Center for the Study of Drug Development research established that drug developers routinely need to nearly double their original site count to hit enrollment targets, a patch that adds cost and calendar time without fixing the underlying dysfunction at any individual site. When 59% of those sites are already hemorrhaging patients to internal inefficiencies, adding more sites compounds the problem as much as it solves it. You get more broken pipes, not more water. The FDA recognized this structural issue when it finalized its guidance on enhancing clinical trial participation in December 2025, explicitly calling for trial designs and site practices that reflect real-world patient populations rather than the narrow cohorts that inefficient screening tends to produce.
The 59% figure also puts pressure on the promise of decentralized trial technology. A 2024 report cited in Science Translational Medicine attributed a 47% increase in participant diversity and a 28% reduction in dropout rates to decentralized approaches across more than 500 trials. Those outcomes are real, but they depend on sites having the operational capacity to execute hybrid or remote workflows. A site choking on referral backlogs and manual pre-screening processes does not suddenly function better because a sponsor introduces an electronic consent tool. Technology layered onto a dysfunctional process produces a more expensive dysfunctional process.
The single metric worth tracking here is screen failure rate broken out by site operational maturity, not protocol complexity. If sponsors and CROs start publishing that disaggregated data consistently, the industry will finally have a credible way to distinguish patient scarcity from site-level inefficiency, and to stop paying for more sites when the real investment belongs inside the ones already open.
Source link: https://www.fiercebiotech.com/cro/over-half-clinical-trial-sites-seeing-recruitment-hindered-inefficiencies-survey
Moe Alsumidaie, MBA, MSF, is founder and Chief Editor of Vanguard Publications, which publishes Clinical Trial Vanguard, Pharma Vanguard and BullScope, and Head of Research at CliniBiz. He has two decades in clinical trial operations and data science, with earlier roles at Genentech, Abbott Vascular and Stanford University Medical Center, and is a guest lecturer in clinical trial sciences at Rutgers University.
