#612: Achieving Regulatory-Grade Pragmatism in Streamlined Trials Embedded in Clinical Practice

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.