Science 37, a company focused on enhancing patient access to clinical trials, played a pivotal role in boosting U.S. enrollment for GSK's Phase 3 rare disease trial. The hepatology study is evaluating an investigational medicine for cholestatic pruritus in primary biliary cholangitis (PBC). Science 37 contributed almost half (17-47%) of the U.S. enrollment for the study, which required 230 global participants.
Decentralized Approach to Rare Disease Trials
GSK adopted an innovative approach to broaden trial access, recognizing the challenges of limited and globally dispersed participant populations in rare disease studies. Science 37’s Direct-to-Participant Site solution enabled participants to engage in the study from their homes, mitigating symptom-related barriers like fatigue that often hinder adherence to traditional clinical trial site visits. This strategy extended geographic access and facilitated real-time, at-home data collection, significantly enlarging the pool of eligible participants.
Enhancing Patient Experience and Engagement
Brandon Maggio, Global Head of Digital Operations & Process Optimization at GSK, stated, “At GSK, we design trials with a patient centric approach which leverages technology and remote services in order to make trials more accessible for participation. Science 37’s innovative services meant we could bring the trial to the homes or neighborhoods of patients in rural areas who would typically have to travel hundreds of miles to the nearest clinical site, which may otherwise have been a barrier to participating.”
Science 37's capabilities allowed screening across most U.S. states, including regions lacking traditional brick-and-mortar sites. Furthermore, participants at risk of dropping out from traditional sites were able to transition to an at-home trial experience, enhancing engagement and maintaining study continuity. This approach resulted in an 82.3% completion rate for Part A of the trial, a critical milestone for assessing the investigational drug's initial effects compared to placebo.
Impact on Enrollment and Study Conduct
Dr. Debra Weinstein, VP of Internal Medicine and Principal Investigator at Science 37, commented, “Once again, Science 37 has demonstrated its unique ability to meet the needs of study sponsors confronted by the most challenging enrollment and study conduct conditions. The enhanced access of a decentralized approach becomes invaluable when sponsors are dealing with small patient populations that are widely dispersed across countries or even continents.”
