Statistical Considerations in Design and Analysis of Active Controlled Clinical Trials
View Presentation *Hsien (James) Hung, FDA Keywords: non-inferiority, multiplicity, margin, sensitivty analysis In regulatory applications active controlled clinical trials may or may not have a placebo arm. Such a trial may be expected to demonstrate that a test treatment is not inferior to the active control. In the absence of a placebo arm, the effect of the test treatment can be established by showing non-inferiority or superiority over the control. Statistical considerations pertaining to non-inferiority testing versus superiority testing are often quite different. This presentation will discuss the following difficult subjects: non-inferiority margin determination, primary analysis method, necessary sensitivity analyses, strength of evidence, multiplicity issues management.
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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