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Activity Number: 646
Type: Contributed
Date/Time: Thursday, August 8, 2013 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract - #307897
Title: Validity of Responder Analysis Using Continuous Endpoints
Author(s): Davis Gates*+ and Tulin Shekar
Companies: Merck and Co. and Merck and Co.
Keywords: responder ; NNT ; dichotomizing
Abstract:

In the analysis of clinical trial data, even though dichotomizing continuous outcome data is not a universally accepted practice, it provides a useful tool for clinicians to interpret clinical trials outcomes. In addition, dichotomizing continuous data in preparation for a responder analysis can be used as a tool in clinical trial design. The pros and cons of dichotomizing continuous outcomes are discussed through the use of responder's analysis and numbers needed to treat (NNT's). We will also address the impact on power, sample size, statistical significance and clinical relevance using clinical trials data.


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