pharmaphorum December 23, 2021
The FDA has published draft guidance on how digital health technologies (DHTs) like smart and wearable devices can be used to capture data remotely from patients in clinical trials – an approach that has come to the fore since the start of the pandemic.
The new guidance sets out the regulator’s current thinking on how trial sponsors to incorporate DHTs in the design of studies of drugs or medical devices.
COVID-19 has already prompted a big increase in the use of decentralised or remote studies as it became increasingly hard for patients to participate in trials at investigator site, a shift that has relied heavily on the use of DHTs like remote monitoring systems, electronic data collection and consent forms,...
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