Digital Biomarkers in Testing the Safety and Efficacy of New Drugs in Mental Health: a Collaborative Effort of Patients, Clinicians, Researchers, and Regulators.

Recent years have seen a rise in research where so called “digital biomarkers” represent the focal study interest. Many researchers understand that digital biomarkers describe digital footprints providing insights into healthy and pathological human (neuro-)biology. Beyond that the term digital biomarker is also used at times to describe more general concepts such as linking digital footprints to human behavior (which itself can be described as the result of a biological system). Given the lack of consensus on how to define a digital biomarker, the present short mini-review provides i) an overview on various definitions and ii) distinguishes between direct (narrow) or indirect (broad) concepts of digital biomarkers. From our perspective, digital biomarkers meant as a more direct (or narrow) concept describe digital footprints being directly linked to biological variables, such as stemming from molecular genetics, epigenetics, endocrinology, immunology or brain imaging, to name a few. More indirect concepts of digital biomarkers encompass digital footprints being linked to human behavior that may act as latent variables indirectly linked to biological variables.