Digital Health Technologies: Use In Clinical Studies Comes With Practical Challenges
Whether subjects can use their own personal devices, how to manage mid-study technology updates, and the extent to which data gathered will be shared with patients in real-time are all issues that sponsors, investigators and regulators need to consider.
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Electronic Records: US FDA Updates Guidelines On Use In Clinical Investigations
Revised draft guidance includes recommendations on preparing for FDA inspections, considerations for real-world data and digital health technologies, and the need for service level agreements between sponsors and IT providers.
FDA Draft Guidance Paves Way For Collecting Clinical Study Data Via Digital Health Technologies
The US FDA released draft guidance on how device makers, investigators and other stakeholders can use digital health solutions to collect data from clinical study participants remotely. Comments are due to the agency by 22 March 2022.
Real-World Evidence Should Be Flagged In US Drug And Biologic Applications
FDA will track RWE submissions under INDs, NDAs or BLAs and wants sponsors to use a simple, uniform format to identify real-world data sources and evidence generated from that data in such filings.