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

CNS drug development has become internationally driven and implemented. As a result, new scientific, regulatory, cultural, and operational complexities need to be considered for successful outcomes. The working group will initially prioritize a focus on the impact of multiple cultures and health systems on key outcome measures. One area that needs immediate attention in CNS clinical trials is the procedures for harmonizing various types of outcome measures (patient-reported outcomes, clinical rating scales, performance-based cognitive measures) across cultures in a regulatory context. 

Following an identification of the specific area of focus, the output of the Working Group will be a guidance document or data driven manuscript on the specific topic.