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Activity Number:
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95
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Type:
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Topic Contributed
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Date/Time:
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Monday, August 7, 2006 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #305999 |
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Title:
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Hypothesis Testing in Clinical Study with Mixed Patient Population
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Author(s):
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Yonghong Gao*+ and Chul H. Ahn
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Companies:
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U.S. Food and Drug Administration and U.S. Food and Drug Administration
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Address:
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1350 Piccard Drive, Rockville, MD, 20850,
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Keywords:
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testing ; mixed patient ; subgroup ; OPC
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Abstract:
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In a one-arm registry study for a medical device, an objective performance criterion (OPC) is sometimes used to approve the studied device. In some medical device registry studies, the target patient population consists of two subgroups of patients with unknown proportions, and the overall OPC for the target population (usually unknown) is expressed as the weighted average of two individual OPCs defined for each subgroup. This presentation will propose the idea of random sampling to estimate the overall OPC and test statistics to implement the hypothesis testing. Simulation results will be given to compare the performance of the proposed test statistics.
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