Abstract
Digital therapeutics (DTx) represent “an emerging health discipline that uses technology to augment or even replace active drugs in disease treatment.” Demonstration of new medical product safety and efficacy depends on the generation of data quality and integrity through clinical development while ensuring the safety of trial participants. This chapter discusses key historical challenges of traditional randomized clinical trials relative to enrollment and retention of participants, which led to a sudden clinical trial transformative change with the adoption of decentralized clinical trials. DCTs rely on a complex technology architecture to deliver end-to-end and fit-for-purpose solutions, which consist of multiple trial-related remote components and functions integrated by a mobile health platform that is multifunctional and interoperable. Traditional clinical trials such as randomized controlled trials have been critical to bringing many health interventions to millions of participants.
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