GSK's Phase 3 trial for cholestatic pruritus in primary biliary cholangitis (PBC) saw a significant boost in U.S. enrollment thanks to Science 37's decentralized trial approach. The trial, which required 230 global participants, benefited from Science 37's contribution of nearly half (17-47%) of the U.S. enrollment.
Overcoming Barriers in Rare Disease Research
Recognizing the challenges of enrolling patients in rare disease studies, GSK embraced an innovative approach to expand trial access. Science 37's Direct-to-Participant Site solution allowed patients to participate from their homes, reducing the burden of frequent site visits, especially for those living far from traditional clinical sites. This approach addressed symptom-based barriers such as fatigue, which can hinder adherence to traditional trial protocols.
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."
Enhanced Patient Engagement and Study Continuity
Science 37's capabilities allowed screening across most U.S. states, including areas without traditional brick-and-mortar sites. Furthermore, the decentralized model enabled participants at risk of dropping out from traditional sites to transition seamlessly to an at-home trial experience, maintaining study continuity. This strategy resulted in an impressive 82.3% completion rate for Part A of the trial, a crucial milestone for evaluating the investigational drug's initial effects compared to placebo.
The Impact of Decentralized Trials
Dr. Debra Weinstein, VP of Internal Medicine and Principal Investigator at Science 37, emphasized the value of decentralized approaches in rare disease research: "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."
