End of FDA Commissioner Makary’s Tumultuous Tenure Leaves Agency in Transition

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.

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.

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%.

In this video interview, Kent Thoelke, CEO of Paradigm Health, calls for safe harbor protections, CMS reimbursement safeguards, and funding mechanisms modeled on EHR meaningful use to help community and rural institutions participate in research on par with academic centers.

In this Q&A, E.K. Koh, chief product officer at Suvoda, discusses what separates a trustworthy AI assistant from one that adds risk, why curated clinical knowledge matters more than general-purpose flexibility, and what safeguards must be in place when assistants move from answering questions to taking actions in clinical trial systems.

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.

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.

Pacing obesity trial enrollment, anchoring eligibility to stable real-world therapies, and building site and physician relationships improve retention and data quality more than aggressive recruitment or restrictive exclusion criteria do.