Science 37 facilitated significant U.S. enrollment in a Phase 3 trial for cholestatic pruritus, enhancing patient access through remote participation.
Quiver AI Summary
Science 37, a leader in improving patient access to clinical trials, played a crucial role in a Phase 3 rare disease trial sponsored by GSK, contributing nearly half of the U.S. enrollment for the study on cholestatic pruritus in primary biliary cholangitis (PBC). GSK utilized Science 37's Direct-to-Participant Site solution to help overcome barriers faced by patients, allowing them to participate from home, which reduced travel burdens and improved engagement. This innovative approach proved effective, with 82.3% of participants completing the critical initial phase of the trial, demonstrating the value of decentralized clinical trial solutions in reaching dispersed rare disease patient populations. Both companies emphasized the importance of patient-centric trial designs and leveraging technology to enhance participation and data quality.
Potential Positives
- Science 37 successfully contributed to nearly half of the U.S. enrollment for a significant Phase 3 rare disease trial, showcasing its ability to address challenging enrollment conditions.
- Utilizing its Direct-to-Participant Site solution, Science 37 significantly enhanced patient access to clinical trials by allowing participants to engage from home, thereby reducing the burden of travel and improving study continuity.
- The trial achieved a high completion rate of 82.3% for Part A, indicating the effectiveness of Science 37's decentralized approach in maintaining participant engagement.
Potential Negatives
- Science 37 contributed nearly half of the U.S. enrollment for a critical Phase 3 trial, highlighting a potential dependency on their services that may raise concerns about their capacity and reliability for future studies.
- The press release emphasizes the challenges of participant recruitment in rare diseases, which may reflect poorly on the overall industry and suggest a limited pipeline for Science 37's services.
- The reliance on remote participation for increasing enrollment might indicate that traditional clinical trial methods are becoming inadequate, potentially undermining the perceived effectiveness of in-person trials.
FAQ
What was Science 37's role in the GSK Phase 3 trial?
Science 37 was a key enrolling site, contributing 47% of the U.S. participants in the trial.
How does Science 37 enhance patient participation in clinical trials?
Science 37 uses a Direct-to-Participant Site solution, allowing participants to join trials from home, reducing travel burdens.
What kind of trial did GSK sponsor with Science 37?
GSK sponsored a Phase 3 trial for an investigational medicine addressing cholestatic pruritus in primary biliary cholangitis.
What were the completion rates for participants in the trial?
82.3% of participants completed Part A of the trial, a crucial milestone for evaluating the investigational drug.
How does Science 37 support rare disease research?
Science 37 expands access to rare disease trials by reaching dispersed patient populations and facilitating remote data collection.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
Full Release
MORRISVILLE, N.C., Nov. 21, 2024 (GLOBE NEWSWIRE) -- Science 37 , a leader in enhancing patient access to clinical trials, was a key enrolling site for the primary completion of a Phase 3 rare disease trial sponsored by global biopharmaceutical company, GSK . The hepatology study of an investigational medicine for cholestatic pruritus in primary biliary cholangitis (PBC) required 230 global participants, of which Science 37 was able to contribute almost half (17 - 47%) of the U.S. enrollment for the study.
Recognizing that the available participant population for rare disease studies is often extremely limited and dispersed globally, GSK welcomed an innovative approach to expanding trial access—one that would also help patients overcome symptom-based barriers such as fatigue that make it challenging to adhere to frequent site visits required in traditional clinical trials. Science 37's Direct-to-Participant Site solution allowed participants to take part in the study from home, reducing participant burden, especially if they lived far from traditional brick-and-mortar sites. By extending geographic access and facilitating real-time, at-home data collection, Science 37 significantly expanded the pool of qualified participants, a key factor to its U.S. enrollment contribution.
“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,” said Brandon Maggio, Global Head of Digital Operations & Process Optimization at GSK.
GSK’s ongoing commitment to producing research data of the highest quality has led them to emphasize trial solutions that enhance the patient experience. Science 37 had the capabilities to screen across most U.S. states, in many places where there were no brick-and-mortar sites participating. Additionally, Science 37 enabled participants at risk of dropping out from traditional brick-and-mortar sites to transition seamlessly to an at-home trial experience, enhancing engagement while maintaining study continuity. This strategy led to impressive results, with 82.3% completing Part A of the trial—the crucial milestone for evaluating the investigational drug's initial effects compared to placebo.
"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,” said Dr. Debra Weinstein, VP of Internal Medicine and Principal Investigator at Science 37. “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.”
For more information about Science 37’s enrollment solutions and its role in delivering qualified participants to clinical research studies such as the GSK PBC trial, please visit www.science37.com .
About GSK
GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com .
About Science 37
Science 37 accelerates clinical research by expanding patient access to trials, leading to faster approvals and better health outcomes. Our Metasite™ and Patient Recruitment solutions enable life sciences companies to reach beyond traditional means of conducting clinical research. To learn more, visit www.science37.com , or email [email protected] .
To view studies that Science 37 is actively recruiting for, please visit https://studies.science37.com/current-studies .
Media Inquiries
Science 37
[email protected]
