Lexology January 4, 2022
In a recently published draft guidance document, the U.S. Food and Drug Administration (“FDA”) outlined important factors to facilitate the use of digital health technologies (“DHTs”) for remote data acquisition in clinical investigations.[1] With the increasing interest and emphasis on decentralized trial designs, sponsors should continue to carefully assess opportunities to use DHTs, and legal and regulatory teams should prepare to help support and evaluate possible risks with using DHTs in clinical trials.
The COVID-19 pandemic has accelerated opportunities to use decentralized clinical trials and regulators continue to issue guidance about how sponsors can conduct such trials and how regulators will accept data from such trials for marketing authorization. DHTs offer the opportunity to capture data remotely and may expand...
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