Inferiority Index and Non-inferiority Margin Specification
View Presentation *Gang Li, Johnson & Johnson Keywords: Inferiority index The specification of a margin in a non-inferiority trial is often subject to challenge and disagreement. The main reason can be attributed to the subjectivity associated with the current procedures for the non-inferiority margin determination. We introduce the concept of an inferiority index which measures the inferiority level of the study treatment to the control. We establish its link to non-inferiority margin. Through this relationship, the inferiority index can be used as a standard relative to which and it can also provide guidance in the determination of a non-inferiority margin in conjunction with clinical input and historical data. Specifically, this relationship is investigated under survival, normal and binomial distribution. A general theorem is given that establishes the asymptotic normality of a test statistic for the non-inferiority hypothesis defined by the margin so derived. Some examples from non-inferiority trials are used to illustrate the usefulness of inferiority index.
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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