Enrollment Case Study
Enrollment acceleration in a global Phase 3 critical care program
As Vice President of Clinical Development and the company’s senior medical leader, Dr. Fineberg led a multidisciplinary team to address slow enrollment in a multinational Phase III critical care study with highly enriched eligibility criteria, driving a substantial improvement in enrollment. By its conclusion, the study had 150 active sites and had enrolled patients across 25 countries.
Dr. Fineberg managed the medical affairs team and worked closely with clinical operations, combining direct investigator engagement, practical eligibility tools, and structured screening data collection. He personally visited more than 100 sites per year over several years. Members of his team also conducted extensive site visits, dividing regional responsibilities to support investigators and study staff across the global program.
Findings
Understanding why patients were being missed
The study’s highly enriched eligibility criteria made accurate patient identification and timely screening essential. Through direct discussions with investigators and study teams, Dr. Fineberg and his colleagues examined how the protocol fit into everyday clinical practice and where potentially eligible patients were being missed.
At some sites, a laboratory test required to establish eligibility was not routinely ordered. Patients could therefore pass through clinical care without being recognized as candidates for the study. Addressing that gap required physician engagement, targeted education, and practical changes to patient identification workflows.
Tools
Making the protocol easier to apply
Dr. Fineberg and his team developed an electronic protocol incorporating an eligibility algorithm. Site personnel could enter patient laboratory values and receive a red, yellow, or green traffic light indication to help assess whether the patient met the relevant eligibility criteria.
The tool translated complex protocol requirements into practical screening support. It helped sites assess potential candidates while leaving final eligibility determination subject to the complete protocol and investigator review.
Dr. Fineberg also developed a detailed method for collecting screening data across 25 countries. This provided a structured basis for examining the screening process and understanding barriers between patient identification and enrollment.
Actions
Turning site findings into operational action
Medical affairs and clinical operations worked together to translate site findings into targeted interventions. The broader enrollment strategy included staffing coverage and budget review at selected sites, laboratory alerts and other patient identification tools, and prioritization of sites with credible recruitment potential.
The team reviewed underperforming sites and opportunities to add or replace sites. Continuing communication, defined regional responsibilities, and review of recruitment measures connected investigator engagement with operational follow through.
Outcome
Documented improvement
Contemporaneous study records reported higher quarterly enrollment than in the corresponding prior year period, with monthly recruitment targets achieved for three consecutive months. The trial subsequently completed recruitment.
The improvement reflected a coordinated effort involving multiple team members and interventions. The available records do not isolate the contribution of any single measure.
Takeaway
What this experience brings to DF Clinical
This experience informs DF Clinical’s approach to slow enrollment: engage investigators directly, understand how trial requirements fit into clinical practice, equip sites with practical screening tools, and coordinate the operational changes needed to improve enrollment.
This case describes Dr. Fineberg’s prior sponsor side experience. The trial and sponsor names have been omitted.
Discuss your enrollment challenge
Share where the study stands and what is limiting enrollment. The first conversation can focus on the principal concern without assembling a full report.