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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Main Authors: Jacqueline Lutz (Author), Emanuela Offidani (Author), Laura Taraboanta (Author), Shaheen E. Lakhan (Author), Timothy R. Campellone (Author)
Format: Book
Published: Frontiers Media S.A., 2022-08-01T00:00:00Z.
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