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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Detalles Bibliográficos
Autores principales: Lutz, Jacqueline, Offidani, Emanuela, Taraboanta, Laura, Lakhan, Shaheen E., Campellone, Timothy R.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2022
Materias:
Digital Health
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9436387/
https://www.ncbi.nlm.nih.gov/pubmed/36060538
http://dx.doi.org/10.3389/fdgth.2022.823977

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9436387/
https://www.ncbi.nlm.nih.gov/pubmed/36060538
http://dx.doi.org/10.3389/fdgth.2022.823977

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