The Role of Digital Measures in Clinical Trials: Exploring the use of digital biomarkers, outcomes, and endpoints in studies of interventions for serious mental illness

This research focuses on the potential of digital health technologies (DHTs) to transform how clinical trials are conducted for serious mental illnesses (SMI) like schizophrenia and bipolar disorder. By using devices such as smartphones and wearables, this project aims to collect patient-generated health data more effectively and predict health outcomes. A key part of the work involves a 'scoping review', a comprehensive method to evaluate existing studies and identify research gaps.

Through a combination of systematic reviews, policy analysis, and interviews with patients living with SMI, the project seeks to understand how digital tools can better support healthcare decisions and patient monitoring. The goal is to improve clinical trial designs, making them more patient-centred and efficient. Digital tools could help in accurately collecting health data from patients outside of clinical settings, providing insights that could lead to better patient outcomes. This could lead to more precise and personalised care for those with SMI, ultimately enhancing treatment outcomes and patient wellbeing.