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

The use of digital biomarkers and digital monitoring has increased considerably and offers a new way to improve diagnostic and therapeutic research and development. While this new approach has been embraced by stakeholders, its use in mental health has been slow. Current research suggests that there is an urgent need to incorporate digital approaches to patient care and monitoring, especially in the realm of mental disease because they are unrestricted by time and place, offer immediate access to data and intermediate endpoints, reducing stressful visits, remove barriers to access to care (fear, isolation), stimulate patient empowerment, and, most importantly, help in the identification of high-risk patients and their risk stratification. Using digital biomarkers and digital tool kits is promising but we must overcome the present disconnect between the promises they contain and potential risks in using these new technologies in the absence of regulatory support. The digital era, which includes digital tool kits, phenotyping, surveillance, and biomarkers falls in the realm of precision medicine and underlines its importance while embracing a new approach.

This Research Topic aims to provide a platform for experts in the field, bringing together research across a variety of fields that consider multiple angles of this novel approach and discuss evidence and up-to-date knowledge regarding their usefulness as diagnostic and prognostic tools, but also the barriers and impediments to its implementation.

We welcome studies (including Original Research, Perspectives, Reviews, Mini-reviews, General Commentaries, Opinion, and Data Reports) that explore these topics. Potential topics will include, but are not limited to:

• Wearable digital devices in testing the safety and efficacy of new drugs in mental health: a collaborative effort of patients, clinicians, researchers, and regulators.
• Digital outcome and assessment in mental health
• Digital biomarkers for the early diagnosis of precipitating factors
• Remote digital monitoring for drug development and regulation in mental health
• Digital phenotyping to inform novel targets for diagnostic and/or therapeutic intervention.
• Digital monitoring for pharmacovigilance and behavioral toxicity.