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Abstract Details
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Activity Number:
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132
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Type:
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Contributed
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Date/Time:
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Monday, August 1, 2011 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #303054 |
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Title:
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Multiplicity Issues in Clinical Trials with Co-Primary Endpoints, Secondary Endpoints, and Multiple Dose Comparisons
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Author(s):
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Haiyan Xu*+ and Pilar Lim
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Companies:
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Johnson & Johnson Pharmaceutical R&D, LLC and Johnson & Johnson Pharmaceutical R&D, LLC
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Address:
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, , NJ, ,
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Keywords:
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Multiple endpoints ;
Multiplicity ;
Clinical trial ;
Gatekeeping
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Abstract:
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In clinical trials there are situations when the overall type I error rate needs to be controlled across co-primary endpoints and secondary endpoints. For example, a health authority may require improvement in both pain and functioning as compared to placebo for the treatment of pain due to osteoarthritis. The sponsor may also be interested in claiming efficacy in additional secondary endpoints in such a trial. The multiplicity issue can be further complicated by multiple dose comparisons. This paper proposes several methods that control the overall type I error for these situations. These methods are constructed using the closed testing principle and the partitioning principle. This paper also compares these methods with the IUT (intersection-union test) based method that is commonly used in testing co-primary endpoints.
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Authors who are presenting talks have a * after their name.
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