In today's ACT Brief, we examine how AI enables sponsors to pressure-test protocols before enrollment, HHS's multi-initiative effort to accelerate trial design and execution, and FDA approval expanding heart disease therapy to adolescents.
News|Podcasts|December 3, 2025
ACT Brief: FDA’s Agentic AI Rollout, Exercise Interventions for Long COVID, and Patient-Centered Evidence Beyond the Trial
Author(s)Andy Studna, Senior Editor
In today’s ACT Brief, we look at the FDA’s deployment of an agency-wide agentic AI platform, review new data showing how structured exercise programs can improve long COVID symptoms, and explore how PROs and real-world evidence are reshaping how industry measures treatment impact.
This is the Applied Clinical Trials Brief—your fast track to the latest insights in clinical research operations. In under three minutes, we’ll recap top stories, highlight expert perspectives, and keep you current on what’s moving the industry.
- The FDA has
launched a secure, GovCloud-based agentic AI system to support regulatory workflows across review divisions, inspections, and post-market monitoring. The platform aims to streamline administrative tasks and help staff manage growing data complexity while maintaining required human oversight. - A new randomized
trial in JAMA shows that a three-month resistance exercise program can improve walking capacity, strength, and quality of life in adults with long COVID. Conducted across community and hospital settings, the intervention demonstrated strong adherence and minimal adverse events, reinforcing exercise as a practical option for persistent post-COVID symptoms. - A new
analysis from Pharmaceutical Executive outlines how PROs and real-world evidence are expanding how treatment impact is evaluated beyond traditional clinical endpoints. As these data gain regulatory traction, sponsors are increasingly relying on statistical computing environments to generate standardized, reproducible outputs that support submissions.
That’s all for today’s ACT Brief. Join us tomorrow for more updates shaping clinical operations and drug development. Thanks for listening.
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