Evaluation, Acceptance, and Qualification of Digital Measures: From Proof of Concept to Endpoint

EN BREF ...

"Maturation of the digital health field, and digital mea- sures in particular, requires that successful proof of con- cepts evolve into tools that can be the basis for decision making in clinical development. Frameworks have been proposed for the overall digital measure development and evaluation process, and specifically for the way in which a digital measure is evaluated as fit for purpose. We build on those works to provide current examples of digital health measurement tools and extend those frame- works by presenting key decisions and challenges at dif- ferent stages of this journey, as well as practical consider- ations at each step. Our motivation is to help those frame- works to be applied and to support more highly relevant and high-quality digital measures to make the transition from proof of concept to scale. Here, we use examples to support the development of digital clinical endpoints for medical product development through collaboration and shared industry best practices and make recommenda- tions for how to accelerate the process. Previously, adding novel digital measures to a trial was often perceived by industry as too risky. Given the COVID crisis, we argue that it is now too risky not to. As our reliance on dig- ital drug development tools increases, so too must the rig- or and consistency of their evaluation." En bref issu de l'étude.