Decentralized Study Guidance Part 1

On May 2, 2023, the U.S. Food and Drug Administration (FDA) fulfilled its commitment under the FDA Reauthorization Act (FDORA) by issuing preliminary instructions regarding decentralized clinical trials (DCTs). This guidance aims to “support the use of DCTs in drug, biologic, and device trials, where some or all trial-related activities occur outside of traditional clinical trial sites.”¹

Although the FDA's regulatory obligations apply equally to both decentralized clinical trials (DCTs) and traditional site-based studies, the distinct characteristics of DCTs call for specific guidelines. Consequently, this newly introduced preliminary guidance encompasses an extensive array of recommendations to address these unique requirements.

But what are the most important takeaways from the draft guidance? And what do you need to do about them right now? Part one of this two-part series reveals three essential decentralized trial guidance takeaways and how teams can achieve compliant and streamlined DCT implementation.