Today, the FDA released its draft guidance on "Decentralized Clinical Trials for Drugs, Biological Products, and Devices". As the name implies it is aimed to provide guidance on developing new drug and biologic therapies, as well as digital health technologies (devices) within decentralized clinical trials (DCTs). The background section notes that these trials "may enhance convenience for trial participants, reduce the burden on caregivers, and facilitate research on rare diseases and diseases affecting populations with limited mobility or access to traditional trial sites. This may help improve trial participant engagement, recruitment, enrollment, and retention of a meaningfully diverse clinical population."
Since there are no sites related to DCT, the draft guidance still recommends a physical location for record keeping, which can also serve as the location for review during regulatory inspections. Another section discusses the use of digital health technologies, their inclusion, use and data management. The guidance includes sections on sponsor, investigator and IRBs. It also discusses dosing of drug and biologic therapies that ensure patient safety as a principle consideration. Many more detail are in the guidance for anyone working in this space.
As with all draft guidance, the FDA has opened a public comment period (info at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/decentralized-clinical-trials-drugs-biological-products-and-devices)
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