FDA Issues Draft Guidance on Decentralized Clinical Trials (1)

Drug and device companies could opt for running their clinical trials remotely if they are trying to put a simple product on the market that already has a solid safety profile under FDA draft guidance released Tuesday on conducting what’s known as decentralized clinical trials.

Traditionally, data collection in clinical trials occurs only when a participant visits the investigator’s location and someone on the research team collects the measurements and follow-up information they need. A decentralized model takes advantage of technologies such as wearables so that some or all of the trial activities occur outside of the traditional setting.

Decentralized ...