Decentralized Trials Guidance May Reflect US FDA’s Lessons Learned During COVID-19
Work on guidance that was originally expected in 2020 continues as the agency and industry learn more about the utility and spectrum of decentralized trials as a result of the novel coronavirus pandemic.
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Draft guidance notes that data obtained from a decentralized clinical trial may be less precise than that from a site-based trial, creating challenges in calculating a non-inferiority margin. FDA specifies what should be included in DCT data management, trial monitoring and safety monitoring plans.
A new multi-stakeholder alliance wants to improve the adoption of decentralized clinical trials that have already drawn much attention during the COVID-19 pandemic. There are plans to aggregate best practices, share evidence and information, and identify and address key barriers.
The international association of contract research organizations, ACRO, has developed a toolkit that it hopes will propel greater adoption of decentralized clinical trials.