The FDA issued a draft guidance Dec. 23 detailing how digital health technology can be used to capture data remotely from patients in clinical trials.
The guidance provides recommendations to sponsors, investigators and stakeholders on the use of digital health technologies and how they can facilitate the use of them in clinical investigations.
The recommendation addresses these topics:
- Selection of DHTs suitable for use in clinical investigation
- Verification and validation of DHTs for use in clinical investigation
- Use of DHTs to collect data for trial endpoints
- Identification of risks associated with the use of DHTs during clinical investigation
- Management of risks related to the use of DHTs in clinical investigations