This is the Applied Clinical Trials Brief—your fast track to the latest insights shaping clinical operations and drug development.
- The FDA opened applications for the Expedited IND Pilot, accepting sponsor-qualified research institution pairs through October 30, 2026, as part of Operation TrialBlazer. The eight to ten selected pairs will receive iterative discipline-specific guidance during IND preparation and rolling review of completed components to reduce clinical hold risk and accelerate the path from drug identification to first patient enrollment.
- A benchmarking study from Tufts CSDD announced by Syneos Health examined 133 trials across 81 programs and found no single sourcing model—in-house, full-service CRO, or functional service provider—consistently outperformed others. The data showed greater vendor counts correlated with longer timelines and more quality events, pointing to operating model design and cross-partner coordination rather than sourcing choice as the real performance lever.
- In the latest episode of The Human Side of Clinical Trials, hosted by Brian McGowan, PhD, and Kelly Ritch, both of ArcheMedX, the discussion examined why training completion metrics miss true study readiness. Measuring both competence and confidence during training reveals risks before enrollment begins, enabling sponsors to provide targeted support where gaps exist rather than applying the same approach uniformly across all sites.
That's all for today's ACT Brief. Join us tomorrow for more updates shaping clinical operations and drug development. Thanks for listening.
