By Nancy Yovetich, Ph.D., Principal Research Scientist
A mid-sized biotech company running a randomized, doubleblind, placebo controlled (1:1) Phase 3 CNS pain study, with a single treatment administration, had achieved ex-US approval yet faced significant enrollment challenges when a modified version of the study was implemented in the US. With a goal of 300 participants, the rate of enrollment sat at a mere 0.5 subjects a month. The best laid plans weren’t cutting it.
The Problem: Enrollment Challenges
Initial efforts to strategically adjust the enrollment criterion were disappointingly ineffective. Patient enrollment rates were lagging far behind goals, threatening to delay program start-up and obstruct research advancement. They turned to our experts for critical, creative thinking and innovative solutions.
Implement a series of enrollment strategies and innovative solutions that allow for the opening of additional recruitment pathways to encourage greater participation, while reducing sites’ operational burden and maintaining the integrity of the trial.