In this video interview, Kent Thoelke, CEO of Paradigm Health, describes how manual eligibility screening and swivel-chair data entry force community sites to trade billable patient care for research, and why that burden is so hard to absorb.
News|Articles|February 1, 2003
- Applied Clinical Trials-02-01-2003
New Ways to Recruit Trial Subjects
Author(s)Faiz Kermani, Ph.D, Pietro Bonacossa
To minimize time to market, sponsors must explore new subject recruitment techniques.
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Clinical trials are a vital step toward bringing new drugs to market. U.S.-based clinical trial activities increased by 6% in 2001, the largest rise since 1990.1 But although pharmaceutical companies pay close attention to the science when designing their clinical trials, few consider how they will get enough subjects to participate. As a result, most trials are plagued by delays that can cost pharmaceutical companies millions of missed sales. Delays in getting a drug to market are estimated to cost companies around $1 million a day.2
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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%.
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