Handling Multiplicity Issues in Primary and Secondary Endpoints
View Presentation *Ivan Chan, Merck Research Laboratory Keywords: In clinical trials, multiple endpoints are frequently used to evaluate the treatment effect of new drugs and vaccines. Support for product label may be based on multiple primary endpoints and additionally, multiple secondary endpoints. Therefore, it is important to recognize and appropriately address the multiplicity issue associated with the multiple comparisons in order to control the overall Type I error rate. In this talk, we will discuss and compare several methods for multiplicity adjustment within the family of multiple primary endpoints and among families of multiple primary and secondary endpoints. Power and family-wise Type I error rate of various methods including gate-keeping strategies will be assessed. Examples will be used for illustration and discussion. Finally, recommendations about these multiplicity adjustment methods will be made for practical use.
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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