Science 37 Nearly Doubles U.S. Enrollment for GSK Phase 3 Rare Disease Trial

Rhea-AI Summary

Science 37 achieved significant success in a Phase 3 rare disease trial sponsored by GSK, contributing 17-47% of U.S. enrollment for a hepatology study focused on cholestatic pruritus in primary biliary cholangitis (PBC). The trial, requiring 230 global participants, utilized Science 37's Direct-to-Participant Site solution, enabling patients to participate from home and reducing travel burden. The approach proved highly effective, with 82.3% of participants completing Part A of the trial. Science 37's ability to screen across most U.S. states and facilitate at-home trial experiences helped overcome geographical barriers and maintain study continuity.

Positive

• Contributed up to 47% of U.S. enrollment in GSK's Phase 3 trial
• Achieved 82.3% completion rate for Part A of the trial
• Successfully expanded geographic reach across most U.S. states
• Demonstrated effective patient retention through at-home trial experience

Negative

• None.

Insights

Clinical Research Analyst

Science 37's significant contribution to GSK's Phase 3 rare disease trial demonstrates a breakthrough in clinical trial accessibility and efficiency. The company's Direct-to-Participant approach achieved 47% of U.S. enrollment, nearly doubling traditional recruitment methods. The 82.3% completion rate for Part A is particularly impressive for a rare disease study.

The decentralized trial model addresses two critical industry pain points: geographic limitations and patient retention. By enabling home-based participation, Science 37 expanded the participant pool beyond traditional site locations while maintaining data quality. This success in a hepatology study for primary biliary cholangitis could establish a new standard for rare disease trials, potentially accelerating future drug development timelines.

This partnership with GSK validates Science 37's business model and positions them favorably for future collaborations with major pharmaceutical companies. The successful execution could lead to increased adoption of their platform, potentially driving revenue growth and market share expansion in the $50 billion clinical trials market.

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 science37@science37.com.

To view studies that Science 37 is actively recruiting for, please visit https://studies.science37.com/current-studies.

Media Inquiries

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FAQ

What percentage of U.S. enrollment did Science 37 (SNCE) achieve in GSK's Phase 3 PBC trial?

Science 37 contributed 17-47% of the U.S. enrollment for GSK's Phase 3 rare disease trial in primary biliary cholangitis (PBC).

What was the completion rate for Part A of Science 37's (SNCE) GSK trial in 2024?

The completion rate for Part A of the trial was 82.3%, demonstrating strong patient retention through the Direct-to-Participant Site solution.

How did Science 37 (SNCE) improve patient access in the GSK Phase 3 trial?

Science 37 improved access through their Direct-to-Participant Site solution, allowing patients to participate from home and reducing travel burden, particularly for those in rural areas far from traditional clinical sites.