Appropriate controls for digital therapeutic clinical trials: A narrative review of control conditions in clinical trials of digital therapeutics (DTx) deploying psychosocial, cognitive, or behavioral content

Digital therapeutics (DTx) are software programs that treat a disease or condition. Increasingly, DTx are part of medical care, and in the US healthcare system they are regulated by the FDA as Software as a Medical Device (SaMD). Randomized controlled trials (RCT) remain a key evidence generation st...

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Bibliographic Details

Published in:	Frontiers in Digital Health
Main Authors:	Jacqueline Lutz, Emanuela Offidani, Laura Taraboanta, Shaheen E. Lakhan, Timothy R. Campellone
Format:	Article
Language:	English
Published:	Frontiers Media S.A. 2022-08-01
Subjects:	mHealth psychology digital clinical trials digital health control conditions placebo control
Online Access:	https://www.frontiersin.org/articles/10.3389/fdgth.2022.823977/full