FDA publishes guidance of digital tool use in clinical trials 

The FDA has published a draft document that advises on the use of digital health tools in acquiring data from participants in clinical investigations that evaluate medical products.

In the document, issued Jan. 3, the agency says advances in technology have boosted the power of data collection methodology in clinical investigations and allow for more detailed recordings of participants' daily lives. 

"Compared to intermittent trial visits, the use of digital health tools to remotely collect data from trial participants may allow for continuous or more frequent data collection," the document reads.  

Considerations that investigators and sponsors involved with clinical trials are advised to address include technology selection and risks, record retention and security and validity and usability of tools. 

Comments on the guidance may be submitted here through March 22. 

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