A Methodology for Advancing the Selection of Biomarkers for Use in Psychiatric Clinical Trials

As psychiatric drug development advances towards more personalised medicine, the role of biomarkers has become integral to the investigation of the safety, tolerability and efficacy of a range of psychiatric drugs. Biomarkers can aid in the development of novel therapeutic agents by supporting patient selection or enriching trials with patients more likely to have a specific psychiatric illness (diagnostic and prognostic biomarkers); and stratifying on inclusion criteria
(predictive biomarkers); and by serving as an indicator of drug activity or even as a surrogate for clinical outcome or safety (pharmacodynamic biomarkers). The expanding use of biomarkers has raised many challenges in both the design and conduct of clinical trials and has underscored the need to establish a standard methodology that helps ensure valid data in support of these biomarkers.