TL28: Multi-regional Clinical Trials (MRCT): Challenges and Opportunities
*Sammy Yuan, Merck Keywords: "To accelerate new drug development, clinical trial strategy has expanded to a global level with participation simultaneously from multiple geographical regions under the same study protocol. The possible benefits of this strategy are obvious but the challenges and issues with this strategy are many, including trial or data quality assurance, statistical methods for design and analysis ( to evaluate consistency of treatment effect across regions), difficulty in interpretation of regional differences, and the acceptability by the local regulatory authorities. In addition, an important challenge we are facing now is the lack of harmonization of regulatory guidance on MRCTs from ICH and EMA. In this session, evaluation of statistical challenges and issues related to MRCT, statistical methods for design and analysis for evaluating consistency of treatment effect across regions, summary of current regulatory guidance on MRCT, and discussion on possible solutions and recommendation to deal with MRCT challenges and issues will be presented. In addition, practical consideration on agreement and harmonization for future MRCTs will be explored."
|
Key Dates
-
November 1 - December 17, 2013
Online proposal submission for a session, short course and Town Hall Open -
January 6 - March 11, 2014
Online proposal submission for Roundtables Open -
April 30 - May 28, 2014
Abstract Submission Open -
June 4, 2014
Online Registration Opens -
August 8 - August 22, 2014
Invited Abstract Editing -
August 11, 2014
Short Course materials due from Instructors -
September 1, 2014
Housing Deadline -
September 15, 2014
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 22 - September 24, 2014
Marriott Wardman Park, Washington, DC