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 16, 2025
ACT Brief: AI-Enabled End-to-End Trials, New Phase III Data in HIV, and a First-Line Shift in HER2-Positive Breast Cancer
Author(s)Andy Studna, Senior Editor
In today’s ACT Brief, we close out our McKinsey interview series with a look at how AI could transform clinical trials end to end, review new Phase III data supporting Gilead’s investigational HIV regimen, and examine an FDA approval that reshapes first-line treatment for HER2-positive metastatic breast cancer.
This is the Applied Clinical Trials Brief—your fast track to the latest insights shaping clinical operations and drug development.
- In the final part of our
video interview with Gaurav Agrawal, he explains how AI could enable truly end-to-end clinical trials by improving study design decisions, reducing operational timelines, and automating manual tasks across startup, conduct, and closeout. He also emphasizes that realizing this potential will require meaningful changes to workflows, operating models, and how organizations approach technology adoption across the clinical development value chain. - Gilead has shared positive Phase III
results from the ARTISTRY-2 trial, showing that its fixed-dose combination of bictegravir and lenacapavir achieved non-inferior efficacy to Biktarvy in virologically suppressed adults with HIV. Alongside ARTISTRY-1, the data strengthen the case for a once-daily, single-tablet regimen that could expand future treatment options and support upcoming regulatory submissions. - And the FDA has
approved Enhertu plus Perjeta as a first-line treatment for unresectable or metastatic HER2-positive breast cancer, marking the first new first-line option in more than a decade. The approval, based on Phase III DESTINY-Breast09 data, is expected to influence treatment guidelines and clinical practice by establishing a new standard of care in this setting.
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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