FDA guidance on integrating randomized controlled trials

Yesterday, the US Food and Drug Administration (FDA) issued a draft guidance, “Integrating Randomized Controlled Trials for Drug and Biological Products into Routine Clinical Practice”

When finalized, the FDA noted, these will support the conduct of randomized controlled trials with streamlined protocols and procedures that focus on essential data collection, allowing integration of research into routine clinical practice.

Traditional randomized controlled drug trials typically capture a large amount of patient information at baseline and over the course of the trial. Health care professionals may also collect this data in routine clinical practice interactions with patients. Researchers may be able to use that data to satisfy trial data requirements, reducing the need for dedicated trial sites and duplicative data entry. This may improve convenience and accessibility for participants and allow for enrollment of more representative populations, resulting in more generalizable trial results.