Handling Different Regulatory Authority Endpoint Requirements in Multi-Regional Clinical Trials
View Presentation *Cynthia Girman, Merck Research Laboratories Keywords: endpoint, MRCT, multiplicity Regulatory agencies in different parts of the world may have different requirements for endpoints, which significantly affects the design of registrational multiregional clinical trials (MRCT). Differences between regions may involve which endpoints or timepoints are considered primary, patient populations analyzed, study design, or non-inferiority margins. Guidance on how to handle such differences is lacking and harmonized guidance would be useful. Initially, attempts should be made to reach consistency in hypotheses for a global MRCT. When a consistent approach is not accepted by all authorities, region-specific hypotheses can be pre-defined in the protocol, and because only one primary hypothesis pertains to an individual region, multiplicity adjustment may not be needed. We review approaches to handling different health authority requirements for endpoints within a global program.
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Key Dates
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April 30 - May 22, 2013
Invited Abstract Submission Open -
June 4, 2013
Online Registration Opens -
August 9 - August 23, 2013
Invited Abstract Editing -
August 23, 2013
Short Course materials due from Instructors -
August 26, 2013
Housing Deadline -
September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC