Treating disorders of the central nervous system (CNS) is notoriously challenging, particularly in the fields of psychiatry and neurology. Despite substantial investment, many drugs have failed to demonstrate efficacy in late phase clinical trials, leaving sponsors with few viable options for advancing their compounds, physicians struggling to decide which treatments to give to their patients, and patients in need of effective therapies. Digital biomarkers, which capture physiological and behavioural data have the potential to revolutionize CNS drug development and clinical practice. In this article, we explore the benefits of digital biomarkers for clinical development, physicians, and patients, as well as the challenges presented by their use.

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