Challenges in Utilizing Outcome Measures Across Regions and Cultures

Chairs: Richard Keefe, Stefan Leucht

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. This session will engage speakers with broad experience in international clinical trials.   They will discuss typical approaches and recent advances for harmonizing key outcome measures across countries, languages and cultures in order to improve signal intensity in international clinical trials.  Speakers will describe their experience with large multinational trials in schizophrenia and bipolar disorder, and will report on the progress of the ISCTM working group on harmonization of key outcome measures.  Representatives from regulatory agencies in Europe will comment on the regulatory perspective on the implementation of translated outcome measures in clinical trials.