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.

stethoscope and a smartphone with a medical app, copyspace (3d render)
Decentralized trials offer a more patient-centric approach to data collection. • Source: Shutterstock

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

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