GSK's Phase 3 trial for an investigational medicine targeting cholestatic pruritus in primary biliary cholangitis (PBC) saw a significant boost in U.S. enrollment, thanks to Science 37's decentralized trial approach. Science 37 contributed 47% of the U.S. participants needed for the global study, which required 230 participants.
Overcoming Enrollment Challenges in Rare Disease Research
Recognizing the difficulties in recruiting for rare disease studies, GSK adopted an innovative strategy to broaden trial access. Science 37's Direct-to-Participant Site solution allowed patients to participate from their homes, mitigating challenges like fatigue and the need for frequent site visits. This approach was particularly beneficial for patients in rural areas who would otherwise need to travel long distances to traditional clinical sites.
Brandon Maggio, Global Head of Digital Operations & Process Optimization at GSK, stated, "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."
Enhancing Patient Experience and Data Collection
Science 37's capabilities enabled screening across most U.S. states, including areas without traditional brick-and-mortar sites. The platform also allowed participants at risk of dropping out from traditional sites to transition to an at-home trial experience, ensuring study continuity. This strategy resulted in an 82.3% completion rate for Part A of the trial, a critical phase for assessing 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 trials in rare disease research: "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."
The success of this collaboration underscores the potential of decentralized trials to improve patient access and engagement, ultimately accelerating clinical research in rare diseases.
