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Activity Number:
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539
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Type:
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Contributed
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Date/Time:
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Thursday, August 2, 2007 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #308515 |
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Title:
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Gate-Keeping Testing Without Tears
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Author(s):
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Jianjun Li*+ and Devan V. Mehrotra
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Companies:
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Merck & Co., Inc. and Merck & Co., Inc.
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Address:
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351 N Sumenytown Pike, North Wales, 19454,
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Keywords:
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Gate-keeping procedures ; trial-wise type-I error ; multiple testing ; primary endpoints ; secondary endpoints
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Abstract:
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In a clinical trial, there are one or two primary endpoints, and a few secondary endpoints. When at least one primary endpoint achieves statistical significance, there is considerable interest in using results for the secondary endpoints to enhance characterization of the treatment effect. Because multiple endpoints are involved, regulators may require that the trial-wise type-I error rate be controlled at a pre-set low level. This requirement can be achieved by using "gate-keeping" methods. However, existing methods suffer from logical oddities such as allowing results for secondary endpoint(s) to impact the likelihood of success for the primary endpoint(s). We propose a novel and easy-to-implement gate-keeping procedure that is devoid of such deficiencies. Simulation results and real data examples are used to illustrate efficiency gains of our method relative to existing methods
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