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.
News|Podcasts|October 5, 2026
ACT Brief: AI Adoption Starting Points, Hierarchical Endpoints and Patient Priorities, and Early-Stage Program Termination
Author(s)Andy Studna, Senior Editor
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.
This is the Applied Clinical Trials Brief—your fast track to the latest insights shaping clinical operations and drug development.
- In
part six and final segment of her interview , Claire Riches, VP of clinical solutions at Citeline, offers practical guidance for clinical operations teams beginning their AI journey. She makes the case that the tools are more accessible than many assume and that waiting to start is itself a competitive risk in a landscape where AI-informed trial design is becoming table stakes. - In a
new feature article , Samuel Salvaggio examined why hierarchical endpoints analyzed through pairwise comparisons more accurately reflect multifaceted treatment benefit than time-to-first-event composites. Transparent outcome prioritization, patient involvement in ranking endpoints, and clear reporting of net treatment benefit remain underutilized despite their importance to interpretation and regulatory credibility. Foghorn Therapeutics and Eli Lilly discontinued their early cancer treatment after Phase I data showed insufficient antitumor activity despite acceptable safety , even though the drug hit mechanistic targets in preclinical work. The termination reflects a broader industry shift toward cutting weak programs at the earliest stage rather than advancing them into costlier late-phase trials, with Phase I now accounting for 38% of all disclosed failures, up from 32% in 2020, while approval-stage failures have dropped below one percent.
That's all for today's ACT Brief. Join us tomorrow for more updates shaping clinical operations and drug development. Thanks for listening.
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