Decentralized Trials Guidance May Reflect US FDA’s Lessons Learned During COVID-19
BY SUE SUTTER Executive Summary 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.
The US Food and Drug Administration’s forthcoming guidance on decentralized clinical trials is likely to reflect some of the lessons learned from use of technology to remotely collect clinical data during the COVID-19 pandemic. Decentralization as an operational approach in clinical research is “here to stay,” Isaac Rodriguez-Chavez, an FDA officer for clinical research methodology, regulatory compliance and medical policy development, said during a panel decision at the Biotechnology Innovation Organization’s recent virtual annual meeting. “This is the new way, if you will, of collecting clinical data, adding convenience to participants, maintaining safety” and ensuring data quality and integrity, he said.
9 / September 2020
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