Novel Assays to Address Translational Gaps in Treatment Development (UG3/UH3 Clinical Trial Optional)

The National Institutes of Health (NIH) is seeking applications to identify neurophysiological measures as potential assays for treatment development research. The goal of this initiative is to improve the efficiency of the therapeutic development process by identifying coherence of measures and inconsistencies between the preclinical screening pipeline and clinical evaluation of new treatment candidates. The funding opportunity announcement (FOA) will support efforts to optimize and evaluate measures of neurophysiological processes that are disrupted within or across mental disorders in both healthy humans and in another species relevant to the therapeutic development pipeline. Key aspects of this opportunity include: • The initiative will support initial proof of concept studies aimed at identifying measures for potential development as preclinical assays for evaluating potential new drug and device therapies and their targets. • Data will also reveal assay measures where the performance between preclinical animal species and humans is dissimilar, thus establishing a firm basis for limiting speculative extrapolations of preclinical animal findings to humans. • The ultimate practical goal of this FOA is to hasten the development of more effective treatments for mental disorders.