Case Study on Cholestatic Pruritus Phase 2 Trial

This document is a case study detailing the Phase 2 trial for Cholestatic Pruritus, a rare disease in dermatology. The trial faced significant challenges in patient enrollment due to the traditional site-based approach, which averaged only 0.1 participants per site per month. These challenges were attributed to the geographic dispersion of patients and strict eligibility criteria. Additionally, the complex protocol requirements imposed a high burden on both patients and sites, further complicating recruitment efforts. The solution implemented by Science 37 involved transitioning the trial to a direct-to-patient model, which significantly reduced the burden on participants. Mobile research-grade nurses conducted in-home visits, managed data collection, and facilitated rapid remote screening. This innovative approach not only accelerated enrollment but also exceeded the original recruitment timeline expectations, prompting the trial sponsor to expand Science 37’s contracted capacity due to its strong performance.