Translational and Cultural Adaptation of Key Outcome Measures in International CNS Trials

Co-chairs: Richard Keefe, PhD; Amir Kalali, MD

The increase in the number of CNS trials outside of North America and Western Europe has required the use of a variety of key outcome measures outside of the cultures in which they were developed. Since culture is a major determinant of the manner in which psychopathology is experienced, reported, and assessed, regional and country-specific patterns of measuring psychopathology are potential confounds in interpretation of clinical trials data. The literature is sparse regarding best practices for validating clinician-rated, patient-reported, and performance-based outcomes in international settings. This session will address the processes for validating and standardizing administration procedures for key CNS outcome measures such as patient-reported outcomes, psychiatric rating scales, cognitive measures and functional outcomes.