Digital Health Devices in Clinical Trials
January 8, 2019 | Terry Sharrer
Five issues confront digital devices moving into clinical practice: usability, accuracy, safety, convenience, ease of use and reliability. Consistent accuracy must be first among these. So, the FDA is carrying out “clinical trials” on digital devices. As this piece says: “The Clinical Trials Transformation Initiative (CTTI), a partnership co-founded by Duke University and FDA, is also working to create a framework for greater adoption of sensors and digital biomarkers in clinical trials through a collaborative effort with the pharmaceutical industry, regulatory agencies, contract research organizations, and technology providers.” MORE