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Activity Number:
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599
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Type:
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Contributed
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Date/Time:
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Thursday, August 6, 2009 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #304337 |
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Title:
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Effect of Predictive Performance of a Biomarker for the Sample Size of Targeted Clinical Trials
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Author(s):
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Xiwu Lin*+ and Daniel Parks and Kwan R. Lee
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Companies:
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GlaxoSmithKline and GlaxoSmithKline and GlaxoSmithKline
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Address:
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1250 S Collegeville Rd, Collegeville, PA, 19426,
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Keywords:
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predictive biomarker ; sample size ; targeted clinical trial
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Abstract:
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Recently, targeted designs based on predictive biomarkers have been proposed in clinical trials to increase the study efficiency. Sample size for achieving a desirable power is a major efficiency measure for clinical trials. Based on the calculated sample sizes, the efficiency of the targeted design can be evaluated as compared with the untargeted design. In this paper, we will develop a method that takes into account the biomarker predictive performance when estimating the sample size for the targeted designs and the untargeted designs. Predictive performance of the predictive biomarkers can usually be estimated from pre-clinical study such as cell line experiment or early phase study. Both binary endpoint and time to event endpoint will be considered in this paper.
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