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|December 11, 2025
ACT Brief: AI’s Impact on Trial Timelines, New Strategies in Obesity R&D, and Why Patient Support Needs a Clinical Backbone
Author(s)Andy Studna, Senior Editor
In today’s ACT Brief, we highlight new insights from McKinsey on where AI can meaningfully accelerate clinical development, break down the emerging design and regulatory forces reshaping obesity drug development, and examine why human-centered clinical guidance is becoming essential within an increasingly fragmented pharmacy system.
This is the Applied Clinical Trials Brief—your fast track to the latest insights shaping clinical operations and drug development.
- In a new
video interview with ACT, McKinsey’s Gaurav Agrawal outlines how AI could remove six to 12 months from the development value chain by powering better study designs, reducing white space between phases, automating manual startup tasks, and improving site selection and monitoring strategies—creating cumulative time savings that could meaningfully accelerate trial execution. - A new feature
article on ACT explores how obesity R&D is rapidly shifting in response to potent incretin-based therapies, with sponsors adopting master protocols and basket trials, testing flexible maintenance dosing, monitoring lean mass and nutritional status, and preparing for the FDA’s evolving expectations around long-term evidence, safety, and demographic diversity in weight-loss trials. - And as prescription care becomes more fragmented, a December Pharm Exec
feature argues that PBMs must rebuild continuity through clinician-led support, pointing to growing evidence that nurse and pharmacist interventions improve adherence, reduce adverse events, and help patients navigate benefit complexity—reinforcing that human-centered guidance is critical to ensuring intended therapies translate into real-world outcomes.
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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