How therapeutic expertise and site relationships helped deliver critical data ahead of schedule
Background
A sponsor developing a novel migraine therapy needed supplemental pharmacokinetic (PK) and safety data to support an ongoing late-stage clinical development program and future regulatory submissions.
The Phase II study was designed to evaluate the safety profile of the investigational treatment when administered alongside an approved medication. Conducted exclusively in the United States, the trial planned to enroll approximately 40 patients across four sites. While modest in scale, the study represented an important milestone within the sponsor’s broader development strategy and required efficient execution to maintain program timelines.
Enrollment Challenge
Studies in migraine patients can present unique recruitment and retention challenges, particularly when protocols place significant demands on participants as, in this instance, the requirement to spend long periods of time at the clinic.
In this study, patients were required to complete extensive PK assessments, with some visits lasting up to 12–14 hours. The protocol also resulted in a screen failure rate of approximately 45%, increasing pressure on sites to identify and recruit qualified participants.[BR1.1]
With only four sites participating, every enrollment opportunity mattered. The sponsor needed a partner capable of maximizing site performance and maintaining enrollment momentum despite these challenges.
Site Selection Strategy[BR2.1]
Worldwide recognized that the success of the study would depend on selecting the right sites from the outset.
Leveraging extensive experience in pain and migraine research, the team identified four U.S. sites with proven recruitment capabilities, strong operational performance, and established access to the target patient population. Rather than relying on a larger site footprint, Worldwide focused on leveraging our site relationships to partner with highly qualified sites capable of efficiently identifying eligible patients and maintaining engagement throughout the study.
The team maintained close oversight of enrollment performance and proactively engaged sites whenever recruitment trends showed signs of slowing. Long-standing site relationships and therapeutic-area expertise enabled rapid problem-solving and helped keep enrollment on track.
As one project leader noted:
“When you have the right sites with the right teams and the ability to enroll patients, that’s 80% of the success.”[BR3.1]
Results
Worldwide’s site selection and enrollment strategy delivered measurable results:
- Four U.S. sites activated and enrolled patients [BR4.1][BR4.2]
- Approximately 45% screen failure rate successfully managed
- 42 patients enrolled, exceeding the original enrollment target
- Required completer targets achieved despite participant attrition
- Enrollment completed ahead of the contracted timeline
- Critical PK and safety data delivered to support the sponsor’s broader development program
The study demonstrates the impact that thoughtful site selection, strong site relationships, and proactive enrollment management can have on trial performance. By combining therapeutic expertise with operational execution, Worldwide helped accelerate delivery of key clinical data while keeping the program on schedule.
