ACT Brief: Bayesian Trials Advance, eSource Integration Scales, and FDA Standards Shift

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

• In part two of our video interview with David Morton, PhD, director of biostatistics at Certara, he explained how Bayesian approaches are enabling more adaptive, probability-driven trials, with additional insights still to come in this series. By incorporating prior data and using posterior probabilities to guide interim decisions, these models support continuous learning and more responsive study execution, including earlier stop or go decisions.
• Medidata has partnered with CRIO to integrate site-level eSource directly into enterprise platforms, reducing manual workflows and improving data accuracy. The plug-and-play connection is already supporting more than 2,500 sites globally, with reports of near-perfect data accuracy and significantly faster entry through automated source-to-EDC transfer. The collaboration also reflects a broader push to align site workflows with sponsor systems and expand access to scalable digital infrastructure.
• In a new Pharm Exec video short, Ron Lanton of Lanton, Lanton & Sosa Law discussed the FDA’s move away from its long-standing two-trial gold standard toward a single, well-controlled study supported by confirmatory evidence. The shift is intended to accelerate approvals and patient access while placing greater emphasis on study quality and overall strength of evidence.

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