Among nearly 19,200 cardiovascular trials registered on ClinicalTrials.gov between 2000 and 2025, 11.5% were terminated early, and low recruitment was the single most common reason. That number is the operating pressure behind a Fortrea case study published this month, which details how the company rescued enrollment on a Phase III hypercholesterolemia program that was quietly failing before it officially started.
The trial called for 300 patients across 51 sites in the EU and U.S., with a 23-month enrollment window. Screen failure rates ran higher than projected almost immediately, driven by lab results that disqualified patients who had otherwise looked eligible. Rather than absorb the overrun, Fortrea worked with the sponsor to revise site projections and deployed tailored interventions by site: patient-facing recruitment materials, pre-screening logs to catch ineligible candidates before they consumed a full screening visit, and engagement strategies calibrated to each site’s local referral patterns. The combination kept the program moving without expanding the site count or extending the timeline in ways that would have compounded costs.
The operational detail worth noting is the pre-screening log. It sounds procedural, but its effect is concrete: sites stop spending protocol-mandated screening resources on patients who fail a single lab criterion. In a cardiovascular indication where lipid thresholds, renal function values, or prior medication requirements routinely disqualify otherwise willing patients, catching those mismatches earlier cuts the screen failure rate that derailed the study in the first place. The patient-facing materials addressed a parallel problem, referral quality. Sites that receive vague referrals from community physicians waste time on patients who never had a realistic chance of qualifying.
Cardiovascular trials carry a structural disadvantage: the patient populations are medicated, comorbid, and managed by multiple physicians who may each be running their own trial relationships. A site activation strategy that treats all 51 locations identically will consistently underperform one that segments by site capacity and local referral ecosystem. The Fortrea case study does not publish final enrollment figures or a completion date, so the measurable outcome of these interventions remains the source’s omission to track.
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.
