ACT Brief: CNS Trial Expansion, Vaccine Policy Debate, and New Leadership at FDA

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.

CNS and autoimmune trials continue to surge, with pain, depression, Alzheimer’s disease, and inflammatory conditions driving strong investment across sponsors. In Part 2 of a new ACT video interview, Heidi Chen of Citeline notes that aging populations, revitalized interest in mental health, and expansion of modalities like CAR-T into autoimmune disease are shaping the pipeline. These areas are also among the fastest adopters of decentralized elements, wearables, and hybrid study designs—making operational flexibility and digital readiness increasingly essential for site selection and execution.

A new NEJM commentary from 12 former FDA commissioners warns that the agency’s proposed overhaul of vaccine approvals could slow development and disrupt long-standing regulatory standards. The draft framework—which includes higher evidence thresholds, pregnancy-specific requirements, and reduced reliance on immunobridging—may lead to longer trials, larger sample sizes, and more complex designs. Former leaders argue these shifts could hinder innovation, elevate costs, and create uncertainty for developers navigating future vaccine programs.

And in FDA leadership news, the agency has appointed Tracy Beth Høeg, PhD, as acting director of CDER following Richard Pazdur’s retirement announcement. Høeg, previously Senior Advisor for Clinical Sciences, is expected to advance modernization efforts and strengthen cross-center coordination. FDA also named Karen Murry, MD, as the new head of the Office of Nonprescription Drugs, continuing a year marked by rapid turnover across key drug-review roles.

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