Science 37 Nearly Doubles U.S. Enrollment for GSK Phase 3 Rare Disease Trial
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.
Science 37 ha raggiunto un successo significativo in uno studio di Fase 3 su una malattia rara sponsorizzato da GSK, contribuendo dal 17% al 47% delle iscrizioni negli Stati Uniti per uno studio di epatologia focalizzato sul prurito colestatico nella colangite biliare primaria (PBC). Lo studio, che richiedeva 230 partecipanti a livello globale, ha utilizzato la soluzione Direct-to-Participant Site di Science 37, consentendo ai pazienti di partecipare da casa e riducendo il carico di viaggio. Questo approccio si è rivelato molto efficace, con un 82,3% dei partecipanti che ha completato la Parte A dello studio. La capacità di Science 37 di effettuare screening in quasi tutti gli stati americani e di facilitare esperienze di prova a domicilio ha contribuito a superare le barriere geografiche e a mantenere la continuità dello studio.
Science 37 logró un éxito significativo en un ensayo de Fase 3 sobre enfermedades raras patrocinado por GSK, contribuyendo con un 17-47% de las inscripciones en EE. UU. para un estudio de hepatología centrado en el prurito colestático en la colangitis biliar primaria (PBC). El ensayo, que requería 230 participantes a nivel global, utilizó la solución Direct-to-Participant Site de Science 37, permitiendo a los pacientes participar desde casa y reduciendo la carga de viajes. Este enfoque demostró ser muy efectivo, con un 82.3% de los participantes completando la Parte A del ensayo. La capacidad de Science 37 para realizar cribados en casi todos los estados de EE. UU. y facilitar experiencias de ensayo en casa ayudó a superar las barreras geográficas y a mantener la continuidad del estudio.
Science 37는 GSK가 후원한 희귀 질환 3상 시험에서 중요한 성공을 거두었으며, 이는 1차 담즙성 담관염(PBC)에서의 콜레스테콜 프루리투스에 초점을 맞춘 간 연구에 대한 미국 등록의 17-47%를 차지했습니다. 이 시험은 전 세계적으로 230명의 참가자가 필요했으며, Science 37의 Direct-to-Participant Site 솔루션을 활용하여 환자들이 집에서 참여할 수 있도록 하여 여행 부담을 줄였습니다. 이 접근법은 매우 효과적이었으며, 82.3%의 참가자가 시험의 A 부분을 완료했습니다. Science 37은 거의 모든 미국 주에서 스크리닝을 수행하고 자택 시험 경험을 촉진함으로써 지리적 장벽을 극복하고 연구의 연속성을 유지하는 데 도움을 주었습니다.
Science 37 a connu un succès significatif dans un essai de phase 3 sur une maladie rare parrainé par GSK, contribuant à hauteur de 17 à 47 % des inscriptions aux États-Unis pour une étude en hépatologie axée sur le prurit cholestatique dans la cholangite biliaire primitive (PBC). L'essai nécessitait 230 participants au niveau mondial et a utilisé la solution Direct-to-Participant Site de Science 37, permettant aux patients de participer depuis chez eux et réduisant le fardeau des déplacements. Cette approche s'est révélée très efficace, avec 82,3 % des participants complétant la Partie A de l'essai. La capacité de Science 37 à effectuer des dépistages dans presque tous les États américains et à faciliter les expériences d'essai à domicile a aidé à surmonter les barrières géographiques et à maintenir la continuité de l'étude.
Science 37 erzielte einen bedeutenden Erfolg in einer von GSK gesponserten Phase 3-Studie zu seltenen Krankheiten, die 17-47% der US-Einschreibungen für eine hepatologische Studie zum cholestatischen Pruritus bei primärer biliärer Cholangitis (PBC) beitrugen. Die Studie benötigte 230 globale Teilnehmer und nutzte die Direct-to-Participant Site-Lösung von Science 37, die es den Patienten ermöglichte, von zu Hause aus teilzunehmen und die Reisbelastung zu verringern. Dieser Ansatz erwies sich als sehr effektiv, wobei 82,3% der Teilnehmer Teil A der Studie abschlossen. Die Fähigkeit von Science 37, in nahezu allen US-Bundesstaaten Screening durchzuführen und Erfahrungen aus der Studie zu Hause zu erleichtern, half dabei, geografische Barrieren zu überwinden und die Kontinuität der Studie aufrechtzuerhalten.
- 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
- None.
Insights
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
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 -
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
"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.
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FAQ
What percentage of U.S. enrollment did Science 37 (SNCE) achieve in GSK's Phase 3 PBC trial?
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