ACT Brief: Plausible Mechanism Pathway Implementation Steps, Behavioral Science in Trial Design, and Psychedelic Drug Accelerated Review

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

• In the final segment of her video interview, Mwango Kashoki, MD, MPH, senior vice president and global head of regulatory strategy at Parexel, outlined steps sponsors can take today to avoid delays as plausible mechanism guidance evolves. Early FDA engagement, robust non-clinical programs, adaptive trial designs, and strong confirmatory evidence packages position organizations to navigate the framework effectively as finalization approaches.
• In a new FAQ, behavioral science reveals how recruitment failures and underrepresentation trace to early design decisions rather than late-stage recruitment efforts. Reframing enrollment as a design problem—examining eligibility criteria, visit cadence, site capacity, and geographic access before protocol finalization—prevents costly delays and improves feasibility through observation of real workflows rather than assumptions.
• President Trump signed an executive order directing FDA to accelerate review of psychedelic therapies for mental health conditions, with initial focus on veterans with PTSD and treatment-resistant depression. The action signals potential for compressed regulatory timelines and possible Right to Try pathways, though questions remain about long-term safety data and clinical frameworks for these emerging treatments.

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