Science 37 Nearly Doubles U.S. Enrollment for GSK Phase 3 Rare Disease Trial
November 21 2024 - 8:00AM
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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