Evidentiary Standards Drive Innovation and Patient Access
June 6, 2023
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 these therapies really don't sit in line with all of the evidentiary standards that exist for the current existing treatments and therapies."
"We wanted to talk about this idea of a fit-for-purpose standard that can pull in some of the aspects from traditional therapies into this evaluation framework. This is so a patient, clinician, payer, and policymaker can understand, "Oh, this is what this therapy does, this is how I know it's going to be successful, and this is how I know what the impact is going to be for my patient population."
Whitney elaborates, "The future implications include a better understanding of the clinical evidence dossier, which just means more effective and fair evaluations of the technologies. So, do they need to conduct the same trials and generate the same evidence as pharmaceuticals? No, I think we all are aligned with that. Do they need to go through the same processes as high-risk medical devices? No, they probably don't. Most of them are fairly low-risk. So we've been talking about it just to get everybody on the same page and with the same kind of evaluation criteria so that everyone knows exactly what sufficient looks like."