Addressing Methodological Challenges in International CNS Trials Working Group Dinner
Chairs: Richard Keefe, PhD; Amir Kalali, MD
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 meeting, we gathered input from about 30 attendees regarding their greatest concerns for international clinical trials. Initial responses from the attendees suggested that these issues most require our immediate attention:
– Regional differences in signal detection
– Linguistic and translation difficulties (with patients and investigators)
– Cultural acceptability of outcome measures (e.g., sexual symptoms)
– Impact of cultural values on harmonization (e.g., speed of cognition)
– Recommendations for adapting outcome measures for global clinical trials
– Regulatory (e.g., definitions of partial responder in MDD in US vs EU)
– Nosologic differences (relevance of DSM to non-Western cultures)
– Young versus mature science of measurement (cognition, functional outcomes vs psychosis)
– Payer concerns and standards
We will be collecting survey data from Autumn Conference Workshop attendees, reporting back this information, and establishing a focused agenda with specific discussion points at the Annual Meeting in DC on February 18.