This year’s Scope Summit once again brought thousands in the clinical research space together, offering a glimpse into the evolving operational and technological landscapes shaping the future of trials.
GSK and Medable share how eCOA technology and AI have transformed trial execution
At SCOPE Summit 2025, Christina Fawcett, Director of Digital Health Delivery at GSK, sat down with Andrew Mackinnon, Executive General Manager of Customer Value. Together, they discussed the need for greater control during the study launch period and explored how new technology platforms transform clinical trial execution.
Christina Fawcett, Director of Digital Health Delivery at GSK, sits down with Andrew Mackinnon, Executive General Manager of Customer Value at MedableDuring the discussion, GSK shared their experience during their now three-year partnership experience as an enabled partner with Medable. Their journey involved transitioning from EDC building to integrated eCOA and eConsent systems, with significant improvements in the build process through visual tools and a schedule-based approach. The team achieved notable reductions in validation time through dynamic testing while successfully implementing standardization across therapeutic areas while maintaining necessary flexibility for specific disease areas.
Released in August 2024 and updated with AI in November 2024, Medable Studio helped GSK shift from traditional trial-by-trial development to an enterprise-level approach. The platform features an AI-powered eCOA builder that reduces instrument creation time from weeks to minutes and a comprehensive reusable content library supporting over 120 locales. Its point-and-click interface for study structuring and real-time visualization capabilities enable immediate testing and refinement of trial designs.
The platform's benefits extend well beyond the initial build phase. Through comprehensive initial design, teams have seen accelerated translation processes for global trials and fewer post-launch changes. Site operations have been streamlined through consistent interfaces and a single login solution across multiple studies. The platform has also enabled better patient and site feedback integration, leading to continuous improvements in user experience.
The discussion highlighted a crucial shift in industry use of clinical trial technology: moving from individual study solutions to enterprise-level platforms prioritizing standardization while maintaining therapeutic area flexibility.
Medable nominated for Clinical Research News’s “Best of Show People’s Choice”
On January 31, Medable was nominated for Clinical Research News’s “Best of Show People’s Choice” for its Medable Studio technology.
Clinical Research News’ Best of Show Awards “recognizes the best new products in the clinical research space” and is voted on by conference attendees.
Opening keynote explores: What do real patients actually talk about?
The SCOPE Summit 2025 started with a crucial dialogue on patient representation in clinical trials. The opening panel, "What Do Real Patients Actually Talk About?" tackled misconceptions and highlighted strategies for authentic patient engagement.
Quynh Tran from the Cystic Fibrosis Foundation addressed a critical misconception: the belief that cystic fibrosis primarily affects those of European descent. The foundation actively showcases diverse racial and ethnic representation in its media, emphasizing that the disease affects all communities.
Darious Davis of CenExel emphasized sharing diverse patient experiences, including unsuccessful trial outcomes. He advocated combining individual stories with broader patient feedback data to view patient communities comprehensively.
Dr. Fabian Sandoval highlighted fear as a significant barrier to patient participation. The panel stressed the importance of honest communication between healthcare providers and patients about evolving conditions and treatment options.
Emily McCormack from the New York Blood Center emphasized social media's role in understanding patient challenges. While vocal patient advocates provide valuable insights, social listening reveals broader community experiences and practical concerns like travel barriers.
The panel concluded by discussing technology's role in expanding patient reach. They emphasized creating environments where patients can openly discuss their challenges with clinicians. Dr. Sandoval noted that patients often turn to technology, seeking hope in their healthcare journey.
The discussion underscored a shifting paradigm in clinical research: moving from selective patient narratives to inclusive representation reflecting the true diversity of patient experiences.
What trials may look like in 2035
The future of clinical research and healthcare delivery took center stage at this year's SCOPE conference in Orlando, where industry leaders shared their vision for 2035. TransCelerate Biopharma CEO Janice Chang and former FDA Commissioner Mark McClellan, MD, PhD, now director of Duke-Margolis Institute for Health Policy, delivered a compelling keynote on the convergence of clinical research and care delivery.
Dr. McClellan emphasized that technological advancement isn't the only force pushing towards integration. The healthcare system's digitization and sophisticated analytics and AI capabilities have created unprecedented opportunities. Modern medications can now intercept, halt, and even reverse diseases, necessitating a healthcare system that bridges the gap between clinical trials and practical care delivery.
The conference discussion touched on the changing regulatory environment under the new administration. Dr. McClellan outlined the administration's focus on deregulation and spending reduction, noting these changes aim to address Americans' frustrations with healthcare accessibility, costs, and complexity.
Chang highlighted TransCelerate's commitment to streamlining clinical trial protocols. Their initiatives focus on:
- Simplifying protocol design to align with real-world patient experiences
- Enhancing accessibility and meaningful participation
- Modernizing integrated processes and human interactions
- Improving data interoperability across clinical research and healthcare systems
A crucial challenge identified was the need to build broader awareness and trust among caregivers and patients regarding clinical research. Chang emphasized the importance of improving physician education and participation in clinical trials, viewing these as essential steps toward achieving true convergence of research and care.Dr. McClellan concluded by addressing the challenges of cost and complexity in clinical trials. He highlighted CMS's priority of making healthcare more accessible through data interoperability, patient data control, and payment reforms. The shift from traditional fee-for-service models to coordinated care systems emerged as a key strategy for future healthcare delivery.The discussion underscored that while technological advancement is crucial, successful convergence of clinical research and healthcare delivery will require sustained effort across multiple fronts, from regulatory reform to improved data sharing and enhanced stakeholder education.
