JSM 2011 Online Program

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Abstract Details

Activity Number: 626
Type: Contributed
Date/Time: Thursday, August 4, 2011 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract - #301630
Title: Submitted for Your Consideration: Potential Advantages of a Novel Clinical Trial Design and Initial Patient Reaction
Author(s): Matthew Shane Loop*+ and A. C. Wood and Amy Thomas and James Shikany and Gary L. Gadbury and David B. Allison
Companies: University of Alabama at Birmingham and University of Alabama at Birmingham and University of Alabama at Birmingham and University of Alabama at Birmingham and Kansas State University and University of Alabama at Birmingham
Address: 1665 University Boulevard, Birmingham, AL, 35294,
Keywords: heterogeneity ; response
Abstract:

In many circumstances, individuals do not respond identically to the same treatment. This phenomenon, which is called treatment response heterogeneity (TRH), is observed in treatments for obesity. Estimating the total amount of TRH, predicting an individual's response, and identifying the mediators of TRH are of interest to the obesity field and medical community. Current designs can estimate TRH as a function of specific, measurable observed factors; however, they cannot estimate the total amount of TRH, nor provide reliable estimates of individual persons' responses. We propose a new repeated randomizations design (RRD), which would allow estimates of that variability and facilitate estimation of the total amount of TRH, prediction of an individual's response, and identification of the mediators of TRH. In a pilot study, we asked 118 subjects entering a weight loss trial for their opinion of the RRD, and they stated a preference for the RRD over the conventional 2-arm parallel groups design. Research is needed as to how the RRD will work in practice and its relative statistical properties, and we invite dialogue about it.


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