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

Karger Digital Biomarkers

Goldsack J.C, Dowling A.V, Samuelson D, Patrick-Lake B, and Clay I

ABSTRACT: To support the successful adoption of digital measures into internal decision making and evidence generation for medical product development, we present a unified lexicon to aid communication throughout this process, and highlight key concepts including the critical role of participant engagement in development of digital measures. We detail the steps of bringing a successful proof of concept to scale, focusing on key decisions in the development of a new digital measure: asking the right question, optimized approaches to evaluating new measures, and whether and how to pursue qualification or acceptance. Building on the V3 framework for establishing verification and analytical and clinical validation, we discuss strategic and practical considerations for collecting this evidence, illustrated with concrete examples of trailblazing digital measures in the field.