WST - FDA to broaden access to decentralized clinical trials

2023-05-02 15:43:45 ET

The U.S. Food and Drug Administration (FDA) on Tuesday issued a draft guidance to offer further support for decentralized clinical trials (DCTs) where studies for treatments and medical devices can take place beyond traditional trial sites.

DCTs can lower the barriers to trial participation and improve the diversity of trials as investigators can conduct lab tests at a local site rather than a research center and use telemedicine to do clinical follow-ups.

The proposed guidance marks the latest attempt by the FDA to decentralize clinical trials after the agency issued recommendations for remotely-run studies in response to social restrictions during the pandemic.

"Advancements in digital health technologies and the COVID -19 pandemic—when in-person visits were limited or unavailable for many trial participants—have accelerated the broader adoption of these activities," FDA Commissioner Robert M. Califf said.

The new draft guidance covers areas ranging from design, safety monitoring, and how to source data in a DCT remotely. The draft version has 90 days for public comments before the final guidance is released.

Contract research organizations: ICON Public Limited ( NASDAQ: ICLR ), IQVIA Holdings ( NYSE: IQV ), Medpace Holdings ( MEDP ), Inotiv ( NOTV ), Syneos Health ( SYNH ), PPD (PPD/TMO), West Pharmaceutical ( WST ), Avid Bioservices ( CDMO ), Inotiv ( NOTV ), Societal CDMO ( SCTL )

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