Ieuan Clay

Abstract Digital health technologies (DHTs) have the potential to modernize drug development and clinical trial operations by remotely, passively, and continuously collecting ecologically valid evidence that is meaningful to patients’ lived experiences. Such evidence holds potential for all drug development stakeholders, including regulatory agencies, as it will help create a stronger evidentiary link between approval of new therapeutics and the ultimate aim of improving patient lives.

Introduction Digital health tools are becoming increasingly embedded in all phases of clinical research [1]. As development of the field gathers pace, a special issue of Karger’s Digital Biomarkers (Fig. 1; [2]), produced in partnership with Evidation Health, focused on 3 key themes critical to continued adoption and acceptance of digital health tools: the maturation and regulatory acceptance of existing capabilities, the further innovation of new capabilities, and workforce development.

Key Points A common, unifying lexicon, including key terminology relevant to evaluation and regulatory acceptance and/or qualification, is necessary for the successful development of digital measures for use in medical product development. Early and continuous patient and stakeholder engagement is critical to defining a concept of interest that will remain relevant throughout the digital measure development process.