ACT Brief: Real-Time Evidence Generation, Protocol Digitization, and Decentralized Trial Flexibility

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

• Kevin Bugin, head of global regulatory policy and intelligence at Amgen and executive sponsor of TransCelerate's Embedded Pragmatic Trials initiative, reframed the FDA's data review push as prioritizing real-time evidence generation over continuous data streaming. Regulators are no longer debating pragmatic designs—they're focused on execution and quality-by-design thinking from protocol inception.
• Angie Maurer, vice president of AI-enabled clinical development at Medable, identified protocol digitization as a persistent startup bottleneck finally solvable through LLMs, the USDM standard, and validated operating environments. Digitized protocols transform amendments from cascading manual updates into automated propagation across EDC, IRT, and training systems simultaneously.
• Joan Chambers, independent senior consultant at Tufts CSDD, explained how decentralized trial modalities expand patient access by meeting participants where they are, but emphasized fit-for-purpose deployment is critical. Sites face significant technology burden managing multiple DCT tools alongside traditional operations, and the evidence base for which modalities work best in which contexts is still developing.

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