Mayo Clinic May 12, 2022
The agency’s draft guidelines cover a wide range of complex issues, including patients’ ability to handle remote monitoring devices and correctly record data, how to validate their fitness for use, and how to evaluate patients’ risks while using these digital tools.
By John Halamka, M.D., president, Mayo Clinic Platform, and Paul Cerrato, senior research analyst and communications specialist, Mayo Clinic Platform
The new FDA guidelines, entitled Digital Health Technologies for Remote Data Acquisition in Clinical Investigations, were designed to help clinical trial sponsors, investigators, institutional review boards, and other stakeholders as they navigate a paradigm shift in the way clinical trials are conducted. A growing number of pharmaceutical and academic researchers now realize that collecting massive amounts of clinical data...
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