Autumn 2014 Workshop: Addressing Methodological Challenges in International CNS Trials Working Group
Chairs: Richard Keefe, PhD; Amir Kalali, MD
Overall objective: Generate a consensus document addressing methodological challenges of international CNS clinical trials.
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. In our first two meetings, we gathered input from attendees regarding their greatest concerns for international clinical trials, and decided to focus on the processes for translation and cultural adaptation and harmonization of outcome measures for global clinical trials. The specific stated objective of the group is to establish best practice guidelines on the translation and cultural adaptation of Clinician Reported Outcomes with the ultimate goal of minimizing the impact of culture in clinical trials. We have produced an outline of a manuscript devoted to this topic, and a reading list has been generated and distributed to working group participants. We plan to hold a mid-summer conference call to discuss the reading list, manuscript outline, and to prepare an agenda for the Autumn Working Group Dinner in Boston.