The following previews the issues outlined in the guidance to help sponsors ensure their selected DHT is “fit-for-purpose”:
Considerations for selecting a DHT and rationale for use
The guidance discusses considerations for choosing a DHT including the parameter to be measured, the DHT’s technical specifications and usability, and the trial population and design. Detailed considerations are outlined pertaining to the clinical trial population, DHT specs, design, and operation, as well as for use of a participant’s own DHT, i.e., Bring Your Own Device (BYOD).
DHT description in a submission
In a submission, the sponsor should describe how the DHT is fit-for-purpose, including (but not limited to):