Digital Health Technologies 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.
You may also be interested in...
The FDA’s long-awaited guidance on decentralized clinical trials underscores the importance of digital health tech in clinical trials.
Revised draft guidance includes recommendations on preparing for FDA inspections, considerations for real-world data and digital health technologies, and the need for service level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.
The US FDA released draft guidance on how device makers, investigators and other stakeholders can use digital health solutions to collect data from clinical study participants remotely.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.