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Achieving Regulatory-Grade Pragmatism in Streamlined Trials Embedded in Clinical Practice
Session Chair(s)
Kevin Bugin, PHD, MS, RAC
Head of Global Regulatory Policy and Intelligence
Amgen, United States
Randomized clinical trials embedded in routine care—when designed using Quality by Design principles—can generate regulatory-grade evidence that is scientifically rigorous, operationally feasible, and globally harmonized. This workshop will examine how pragmatic and hybrid RCTs can: Align with ICH E6(R3) expectations; Apply selective safety data collection under ICH E19; Incorporate decentralized elements consistent with FDA guidance; Advance FDA’s STEP demonstration objectives Participants will engage in a structured design exercise debating a pragmatic clinical trial in the obesity setting—contrasting a traditional “overbuilt” protocol with a streamlined, embedded alternative. Through moderated discussion, we will identify critical-to-quality factors, risk mitigation strategies, and the regulatory conversations necessary to support global implementation.
Learning Objective : Apply Quality by Design principles under ICH E6(R3) to pragmatic RCTs in high-impact therapeutic areas; Evaluate where selective safety data collection (ICH E19) may or may not be appropriate in long-term obesity trials; Identify operational and safety risks unique to embedding obesity trials in routine practice—and propose mitigation strategies; Debate the tradeoffs between traditional and streamlined trial designs.
Speaker(s)
Panelist
Mary Thanh Hai, MD
FDA, United States
Deputy Director for Clinical, OND, CDER
Panelist
Henry Wei
Regeneron Pharmaceuticals, United States
Head of Development Innovation
Panelist
Zhanna Jumadilova, MD, MBA
Pfizer, United States
Clinical Lead
Panelist
Representative Invited
Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
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