An evidential approach to non-inferiority clinical trials
View Presentation *Jeffrey D. Blume, Vanderbilt University Sue-Jane Wang, US Food and Drug Administration Keywords: Non-inferiority, Likelihood, Evidence Introduction of likelihood methods for defining the non-inferiority margin and measuring the strength of evidence in non-inferiority trials. Likelihood methods are used to (1) evaluate and combine the evidence from historical trials and (2) assess and report the smallest non-inferiority margin supported by the data. This framework offers important theoretical and practical advantages such as eliminating the influence of sample spaces, and/or prior probabilities, while maintaining good frequentist properties. The methods are illustrated using data from six aspirin-controlled trials for acute coronary syndrome and the active-controlled trial 'Organization to Assess Strategies for Ischemic Syndromes' (OASIS-2). We also explore the evidence for potential violations of the constancy assumption in this framework.
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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