In today’s ACT Brief, we examine how sites can avoid both fear-driven and overly aggressive AI adoption, why community-based research needs sustained financial investment, and why patient access matters more than organizational size.
News|Podcasts|October 27, 2026
ACT Brief: Community Trial Cost Barriers, Measuring What Matters, and Prostate Cancer Approval
Author(s)Andy Studna, Senior Editor
In today’s ACT Brief, we examine how cost barriers and site infrastructure limit participation in community trials, why endpoints should reflect what patients actually experience, and how the FDA expanded a prostate cancer combination to an earlier treatment setting.
This is the Applied Clinical Trials Brief—your fast track to the latest insights shaping clinical operations and drug development.
- In a
video interview , Kent Thoelke, CEO of Paradigm Health, argues that patient cost barriers and site infrastructure challenges must be solved together to close the participation gap in community and rural trials. Cancer patients often say they would join more readily if sponsors helped offset lost wages, copays, and travel. Thoelke also notes that clinic staff spend hours on manual eligibility checks and data re-entry that could go to patient care. - In a
new contributed article , Sylvain Berthelot, host of the On One Condition podcast, argues that trials which stop at biomarkers and rigid rating scales can declare success while leaving patients’ daily burden untouched. He notes that patients with normal lab results can still suffer from fatigue, brain fog, and numbness, and says digital tools deliver meaningful evidence only when they are co-designed with patients. He also warns that excessive questionnaires and devices can drive participants to disengage or withdraw. - The
FDA expanded approval of Pfizer’s Talzenna plus Xtandi to men with metastatic prostate cancer carrying specific gene mutations, moving the combination into an earlier treatment setting. The approval rests on the TALAPRO-3 trial, which randomized 599 patients and found a 52% reduction in the risk of progression or death compared with placebo plus Xtandi. Overall survival data were still immature at the time of analysis, and eligibility depends on a positive genetic test.
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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In this video interview, Kent Thoelke, CEO of Paradigm Health, explains why patient cost barriers and site infrastructure challenges must be solved together to close the participation gap in community and rural clinical trials.
Patients don’t experience primary endpoints, so trials that stop at biomarkers and rigid rating scales risk declaring success while leaving daily burden untouched, and digital tools only deliver meaningful evidence when they are co-designed with patients and deployed with restraint.
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