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 15, 2025
ACT Brief: Training Community Oncology Sites, Digital Tools for Patient-Centric Trials, and New Phase III Momentum in Obesity R&D
Author(s)Andy Studna, Senior Editor
In today’s ACT Brief, we look at new evidence showing how targeted training can build research readiness at community cancer centers, explore McKinsey’s view on how digital tools can make trials more patient-centric and geographically inclusive, and review new Phase III results that could reshape obesity and osteoarthritis treatment.
This is the Applied Clinical Trials Brief—your fast track to the latest insights shaping clinical operations and drug development.
- A new pilot
program from ACCC and ACRP suggests that targeted, oncology-specific training can meaningfully increase research readiness at community cancer centers, helping sites overcome staffing, recruitment, and operational barriers while expanding access to clinical trials for more diverse patient populations outside traditional academic settings. - In the latest installment of our McKinsey interview series, Gaurav Agrawal
explains how clinical operations teams can use real-world data, remote assessments, and digital health tools to reduce patient burden, simplify protocols, and extend trial participation into community-based care environments where most patients already receive treatment. - And Eli Lilly announced positive Phase III
results from the TRIUMPH-4 trial, showing its triple-agonist retatrutide delivered substantial weight loss alongside meaningful reductions in knee osteoarthritis pain, reinforcing growing momentum in obesity drug development and signaling increasingly complex, multi-endpoint trial designs ahead.
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 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.
In today's ACT Brief, we examine what patient-site relationships need beyond easier technology, how to build defensible rare disease evidence from scratch, and how real-world data and AI improve enrollment screening accuracy.
In today's ACT Brief, we examine why defensible trial data depends on traceability and platform ownership, what CGT site readiness requires as therapy moves to community care, and why data harmonization is AI's primary bottleneck.
In this episode of Beyond Compliance, Otis Johnson, PhD, MPA, founder and principal consultant at Vantix Operations, speaks with Cecilia Xi, PhD, VP of clinical and scientific affairs at Vivalink, about why defensible trial data depends on traceability, platform ownership, and device strategy long after a study ends.
Trending on Applied Clinical Trials Online
1
The Control Plane for Agentic Clinical Operations: Governing Autonomous Digital Actors in Regulated Trials
2
HHS Launches SURPASS Program and Three Complementary Initiatives to Transform Clinical Trial Design and Infrastructure
3
Hierarchical Endpoints in Cardiology: How Much Treatment Benefit, and From Where
4
What ClinOps Professionals Just Starting With AI Should Keep Top of Mind
5