ACT Brief Episode 2: FDA Oversight, Vaccine Funding Cuts, and the Digital Future of Clinical Trials

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 interviews, and keep you current on what’s moving the industry. Let’s get into it.

On this episode, we’re spotlighting our three most-viewed articles from the past week—covering regulatory shifts, vaccine funding changes, and the future of digital transformation in clinical trials.

Recent Complete Response Letters to Replimune and Capricor are sending a clear signal: the FDA is turning up the heat on clinical trial design. In both cases, the agency cited inadequate or incomplete trial structures—surprising the sponsors despite earlier communications. Industry leaders warn this marks a shift toward heightened oversight that could impact everything from patient recruitment to timelines. The FDA’s own transparency push, including publishing over 200 CRLs from recent years, reinforces the message: tighten your study designs, document every interaction, and expect less leniency in late-stage approvals.

Turning to vaccines—the US Department of Health and Human Services is winding down mRNA vaccine work under BARDA, canceling 22 contracts worth $500 million. The move shifts funding toward vaccine platforms that officials say are safer and more resilient to viral mutations. Programs at Emory University, Tiba Biotech, and several industry partners are being terminated or scaled back, with some late-stage projects allowed to finish. The decision also halts funding for Moderna’s H5N1 bird flu vaccine, despite positive early trial results. Critics warn the cuts could slow progress in critical vaccine research and disproportionately impact trials involving minority populations.

And in technology, digital tools and AI are rapidly transforming clinical research—accelerating data collection, streamlining processes, and expanding patient engagement options. But with innovation comes complexity. The author of this article highlights five priorities for navigating this shift: strengthening data governance, creating trusted AI frameworks, implementing risk-based processes, upskilling clinical teams, and fostering cross-industry collaboration. The takeaway: technology should enable better science, not dictate it.

For more on this and other developments in clinical research, visit us at appliedclinicaltrialsonline.com. Thanks for listening to the Applied Clinical Trials Brief.