Why Should the FDA Focus on Pragmatic Clinical Research?

JAMA Network June 3, 2024
Ali B. Abbasi, MD; Lesley H. Curtis, PhD; Robert M. Califf, MD

Traditional randomized clinical trials (RCTs) have long been a key tool underpinning drug and device development. The use of individual participant randomization and active or placebo controls in RCTs, combined with comprehensive collection of highly structured data, supports assay sensitivity. At the same time, focused enrollment criteria and careful attention to the collection of adverse events for specified follow-up periods promote detection of toxicities and risks. These...

Today's Sponsors

Today's Sponsor