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Real-World Evidence Demo Projects From US FDA To Include New Mobile App

 
• By Sue Sutter

Agency releases open source code and technical documents for new mobile app designed to gather real-time information about medication use and patient-reported outcomes; app will be incorporated into several PCORI-funded studies that FDA is leveraging as it explores the regulatory utility of real-world data.

Young woman using a touchscreen smartphone.

The US FDA’s real-world evidence (RWE) demonstration projects will feature a new mobile app developed by the agency and its partner in the Sentinel active surveillance system, Harvard Pilgrim Health Care Institute, aimed at making it easier to collect data from patients.

The FDA MyStudies app is a tool to gather real-time, contextual data about medication use and other health issues facing patients. The app uses a web-based tool for creation and...

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