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PubMed

Assessment of digital therapeutics in decentralized clinical trials: A scoping review.

PMID: 40549731 · 2025

JournalPLOS digital health
Year2025
PMID40549731

Abstract

This scoping review aims to identify the necessary and practical considerations for the design, conduct and safety of decentralized clinical trials (DCTs) that test digital therapeutics (DTx) or software as a medical device (SaMD). The review follows the framework of Arksey & O'Malley. A search strategy with the keywords "Digital therapeutics" or "Software as Medical Device" AND "decentralized clinical trial" or synonyms was applied to Cochrane CENTRAL, EMBASE, MEDLINE and Web of Science databas

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