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What Needs to Happen Beyond the Clinical Trial Modernization Act

ACT Brief: Community Research Access, Trustworthy AI Assistants, and Individualized Gene Editing Guidance

Building AI Assistants Clinical Trial Teams Can Trust: Q&A with E.K. Koh, Suvoda

How Embedding Research Into Routine Community Care Changes Who Gets Access

ACT Brief: Community Trial Access Technology, RBQM Infrastructure, and Digital Clone Use Cases

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The FDA’s RTCT initiative transmits predefined, clinically meaningful signals to regulators during active trials, so its value depends entirely on the maturity of sponsors’ upstream RBQM signal intelligence, KRIs, QTLs, and root-cause context, rather than on data speed.

In this video interview, Kent Thoelke, CEO of Paradigm Health, outlines why anti-kickback guidance and modern EHR-integrated trial matching technology must work in tandem to reach representative patient populations at the community level.

In today’s ACT Brief, we examine how legacy workflows pull community clinics away from patient care, why medical writing capacity depends on training rather than technology, and how an antiviral aims to prevent COVID-19 after exposure

Medical writing capacity pressure is fundamentally a talent development problem, not a technology problem, since hybrid resourcing and AI cannot substitute for the experienced judgment needed to review AI output and mentor the next generation of writers.

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.

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.

In this video interview, Rajneesh Patil, global head of AI, digital, and innovation in clinical development at Syneos Health, describes the industry’s trajectory toward a unified intelligence orchestration environment—and explains why the future isn’t one model that knows everything, but a trusted system that brings the right evidence to the right human decision.

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.























