ACT Brief: Bayesian Methods Drive Adaptive Trials, Digital Endpoints Standardized, FDA Enforces GLP-1 Marketing

This is the Applied Clinical Trials Brief—your fast track to the latest insights shaping clinical operations and drug development.

• In a continuing video interview, David Morton, PhD, director of biostatistics at Certara, discussed where Bayesian methods are delivering impact in rare diseases and small populations. These approaches allow researchers to borrow from historical or external controls, and hierarchical models enable information-sharing across disease subtypes in basket trials and pediatric extrapolation.
• A public-private partnership showcased at Pfizer and J&J's Digital Implementation Summit demonstrated how consolidated evidence and standardized terminology are accelerating regulatory-ready digital endpoints. Led by Bayer, Pfizer, and DEEP Measures, the Foundational Content Consolidation project mapped novel digital endpoints across physical activity, sleep, cognition, and speech, creating measurement standards and establishing a shared platform to reduce duplicated validation work.
• On March 3, the FDA issued 30 warning letters to telehealth organizations marketing compounded semaglutide and tirzepatide in a proactive crackdown on GLP-1 advertising. Commissioner Marty Makary emphasized that compounded drugs cannot claim equivalence to FDA-approved products or obscure their sourcing, reflecting a broader shift toward ensuring fair balance of risks and benefits in all promotional content.

That's all for today's ACT Brief. Join us next week for more updates shaping clinical operations and drug development. Thanks for listening.