Empowered Patient Podcast

Fit-For-Purpose Digital Therapeutics Evidentiary Standards Drive Innovation and Patient Access with Whitney Stewart Curebase and Megan Coder Digital Therapeutics Alliance

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Synopsis

Whitney Stewart, the Director of Clinical Project Management at Curebase,  and Megan Coder, the Chief Policy Officer of the Digital Therapeutics Alliance, have worked together on a white paper Setting the Stage for a Fit-For-Purpose DTx Evidentiary Standard. The goal is to outline foundational principles that, in some cases, are unique to the digital therapeutics category. Their focus is on baseline expectations related to procedures and the type, quality, and timing of clinical trials necessary to evaluate and widely implement DTx therapies.   Megan explains, "Given some of their development pathways and processes, given how they're regulated as a medical device and not a drug, we've really started talking with Curebase and some of our other members. We are looking at, and we recognize that, these digital therapeutic products have great value to patient care. They can be used alongside or sometimes even in place of some of these traditional therapies. But what became evident to us pretty quickly is that the