Industry Update
View Presentation *Steve Snapinn, Amgen Keywords: A minimal requirement for any new treatment is that its efficacy be greater than that of a placebo. When the treatment is directly compared to placebo in a randomized trial (or set of trials), demonstrating superiority to placebo is relatively straightforward. However, when the treatment is directly compared to an active control in a non-inferiority trial, demonstrating superiority to placebo requires an indirect comparison and is complicated by the assumptions of assay sensitivity and constancy. A key question is whether superiority to placebo is sufficient in these cases, or whether the existence of an effective therapy requires a higher threshold for any new therapy. In this presentation I will discuss the implications of imposing a higher threshold, and argue that they necessarily lead to logical inconsistencies that outweigh any advantages.
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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