In this episode of "In the Interim…", Dr. Scott Berry and Dr. Kert Viele review the ICH E20 draft guidance on adaptive clinical trial designs, offering a technical yet accessible breakdown for trial sponsors, practitioners, and those interested in clinical development. Drawing on their practical experience in creating and presenting adaptive trial designs to regulators, they discuss the document’s strengths, areas of consensus, and where cautionary or restrictive language appears. Listeners are guided through the evolving regulatory landscape, distinctions between Bayesian and frequentist approaches, and what new harmonization efforts mean for planning adaptive confirmatory trials. The episode conveys hands-on examples, such as the Sepsis ACT seamless trial and the ROAR pan-tumor trial, illustrating technical points with real-world context. Key operational topics—blinding, operational bias, adaptive design reports, and clinical trial simulations—are addressed. The discussion includes practical advice on navigating regulatory dialogue, limitations of ICH E20 in early-phase or nontraditional designs, and the necessity of clear, justification for adaptive (complex) trial features.

Key Highlights

• ICH E20 as a global regulatory framework for adaptive designs
• Tone and caution in guidance may shape sponsor interpretation
• Seamless, Bayesian, and enrichment all confirmatory trials
• Operational guidance: reporting, simulation, interim, and blinding requirements
• Emphasis on justification and transparent communication with regulators

For more, visit: https://www.berryconsultants.com/