Applied Clinical Trials Digital Edition - May 2011, Supplement

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.

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.

Aardvark released exploratory data from its stopped Phase 3 HERO trial in Prader-Willi syndrome after FDA lifted the hold, and plans a redesigned Phase 3.

Clinical trials capture data faster than ever, but the real bottleneck is the distance between data capture and a decision teams can trust.

In today’s ACT Brief, we examine why the future of AI in trials is a trusted orchestration system rather than a single model, how coordinators rate eSource-enabled workflows, and what a bipartisan bill proposes for reusable trial networks.

The Faster Clinical Trials Act would create an FDA Center for Clinical Trial Innovation and aims to cut trial costs and enrollment time by at least 30%.

Standardized measurement across five oncology centers found that clinical research coordinators rated eSource-enabled workflows positively (Overall Mean Satisfaction 5.79 of 7), with reduced manual entry and electronic data transfer earning strong marks, while perceived reduction in sponsor and monitor queries lagged as the one domain below threshold.