Decentralized Study Guidance Part II
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
In part one of this two-part series, the authors discussed three essential takeaways from this new draft guidance. If you missed it, catch up here: Decentralized Study Guidance Part 1. Moving on to part two, readers can gain insight from the four remaining recommendations and what clinical teams need to do about them.
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