In today's ACT Brief, we examine the FDA's multi-domain transparency priorities, why radiopharmaceutical trials need redesigned infrastructure, and how AI can make enrollment more predictable.
News|Podcasts|September 17, 2026
ACT Brief: Expedited IND Pilot Launch, Operating Model Importance, and Readiness Prediction
Author(s)Andy Studna, Senior Editor
In today's ACT Brief, we examine FDA's expedited pathway for first-in-human trials, why operating model design matters more than sourcing strategy, and how early readiness signals predict trial risk.
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.
Related to this article
In today's ACT Brief, we examine FDA input sought on early-phase ibogaine protocols, why mixed outsourcing models spread faster than oversight infrastructure, and a major partnership for a rare kidney disease treatment.
In today's ACT Brief, we examine practical guidance for clinical operations teams beginning AI adoption, how hierarchical endpoints better reflect treatment benefit, and why early-stage program failures signal smarter pipeline management.
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.
In today's ACT Brief, we examine AI's role as trial design advisor with human leadership, how to govern autonomous agents in regulated operations, and real-world outcomes from switching to oral weight-loss therapy.
In today's ACT Brief, we examine how data drives honest enrollment assumptions, why RWE infrastructure lags ambition, and the disconnect between FDA rulemaking and enforcement on compounded therapies.
In today's ACT Brief, we examine what AI simulations surface in trial design, how RBQM delivers measurable financial returns, and three new FDA-approved treatments across hair loss, movement disorder, and bone disease.
In today's ACT Brief, we examine how AI is surfacing endpoint options beyond traditional design thinking, why sponsor oversight of outsourced work often fails on inspection despite being robust in practice, and a new combination drug for advanced kidney cancer.
Trending on Applied Clinical Trials Online
1
FDA Releases Transparency Roadmap Outlining Disclosure Priorities Across Drug Development and Regulatory Review
2
FDA Seeks Public Input on Early-Phase Clinical Trial Design for Ibogaine
3
Beyond the Molecule: Why Radiopharmaceutical Trials Require a New Operating Model
4
Operation TrialBlazer Leveraging New and Anticipated US Policy Changes in Early Development
5