RWE is finding a role earlier in drug development than ever before, but the data quality, integration, and organizational alignment required to make it regulatory-grade are still catching up to the ambition.
|Articles|May 3, 2023
FDA Issues New Draft Guidance on DCTs
Recommendations apply to where some or all the trial-related activities occur at locations other than traditional clinical trial sites.
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The FDA announced
FDA Commissioner Robert M. Califf, MD, said in a press release, “As we seek to improve our evidence generation system, decentralized clinical trials may enhance convenience for trial participants, reduce the burden on caregivers, expand access to more diverse populations, improve trial efficiencies, and facilitate research on rare diseases and diseases affecting populations with limited mobility.”
Reference: FDA Takes Additional Steps to Advance Decentralized Clinical Trials. FDA News Release, May 2, 2023.
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The pilot pairs drug sponsors with qualified research institutions to compress the path from drug identification to first-in-human study through rolling submission review and earlier coordination of institutional review board and site activation activities.
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In today's ACT Brief, we examine how data drives honest enrollment assumptions, why RWE infrastructure lags ambition, and the disconnect between FDA rulemaking and enforcement on compounded therapies.
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