Some New Approaches to Design and Analysis of Subgroups in Randomized Controlled Trials
View Presentation *Sue-Jane Wang, FDA Keywords: consistency-inconsistency, formation of clinically relevant subgroup Conventionally, randomized controlled trials focus on the overall effect of a treatment on the primary efficacy endpoint, assuming that the overall treatment effect is applicable to the entire patient population under study. This paper presentation explores some approaches for possible improvement on the design and analysis of conventional subgroup analysis in a fixed design setting. I shall articulate on formation of clinically relevant subgroups from baseline characteristics, the probability of observing directionally-statistically consistent-inconsistent treatment effects, an interaction-to-overall effect ratio relative to likelihood of a predictor, the roles of interaction test, design consideration, and challenges with full reliance of a single controlled trial. In contrast to the commonly used forest plot for subgroup result summary, a standardized forest plot will be introduced for pre-specified baseline subgrouping factors that may be of supportive interests. Hypothetical or published examples will be used for illustration.
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Key Dates
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November 1 - December 17, 2013
Online proposal submission for a session, short course and Town Hall Open -
January 6 - March 11, 2014
Online proposal submission for Roundtables Open -
April 30 - May 28, 2014
Abstract Submission Open -
June 4, 2014
Online Registration Opens -
August 8 - August 22, 2014
Invited Abstract Editing -
August 11, 2014
Short Course materials due from Instructors -
September 1, 2014
Housing Deadline -
September 15, 2014
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 22 - September 24, 2014
Marriott Wardman Park, Washington, DC