The U.S. Food and Drug Administration (FDA) recently published new guidance on conducting clinical trials with decentralized elements. It offers recommendations for sponsors, investigators, CROs, and other parties that are interested in implementing decentralized clinical trials.

By issuing this guidance now, the FDA is acknowledging the growing role that digital health technologies (DHT) play in medicine, and the potential for more clinical trials to occur away from traditional research settings. Given that decentralized clinical trials (DCT) are clearly on the FDA’s radar, it’s worth taking a closer look at what decentralization entails, how it can help sponsors and participants, and what the FDA recommends for carrying out studies remotely. 

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