ACT Brief: Moving Beyond AI Pilots, FDA Advances Bayesian Trials, and Sites Strained by Trial Design

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

• In the fifth and final part of her Applied Clinical Trials interview, Liz Beatty says sponsors that move beyond AI pilots in 2026 will be those that scale AI across core operations, redesign broken processes, and invest in change management. She notes that AI delivers limited value when layered on top of inefficient workflows, and that sponsors willing to rethink how work gets done are most likely to realize measurable efficiency gains and competitive advantage.
• The FDA has released new draft guidance on the use of Bayesian statistical methodologies in clinical trials for drugs and biologics, outlining how these approaches can support more efficient designs, earlier decision-making, and the use of prior information and external data sources. The guidance fulfills a PDUFA VII commitment and highlights particular value in adaptive designs, rare disease studies, and settings with limited patient populations.
• In a Pharm Exec interview, Trialynx CEO Angela Schwab says research sites often bear the operational burden of poor trial planning and design. Drawing on her experience at the site level, she explains that feasibility decisions are driven by staffing demands, visit intensity, and resource strain across departments, and that overly complex protocols can lead sites to disengage after initially agreeing to participate.

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