Digital Biomarkers in Clinical Drug Development

Abstract Discovering and utilizing appropriate biomarkers have always been an important goal in drug development. Biomarkers have been defined as “a characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, or pharmacological responses to a therapeutic intervention.” More recently the concept of digital biomarkers is beginning to be explored. Digital biomarkers have been defined as “consumer-generated physiological and behavioral measures collected through connected digital tools that can be used to explain, influence, and/or predict health-related outcomes.” This chapter will examine the various definitions, examples, and implications of digital biomarkers as they pertain to drug development.