The views expressed here are those of the individual authors and not necessarily those of the JSM sponsors, their officers, or their staff.
Abstract Details
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Activity Number:
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517
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Type:
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Contributed
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Date/Time:
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Wednesday, August 3, 2011 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #303105 |
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Title:
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Blind Review of Planned Analyses for Clinical Trials
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Author(s):
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Lan Liu*+ and John Schollenberger
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Companies:
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Quintiles Inc. and Quintiles Inc.
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Address:
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6700 W 138th Ter Apt 2012, Overland Park, KS, 66223,
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Keywords:
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blind review ;
ICH E9 ;
prespecification
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Abstract:
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The ICH E9 guidance suggests that a review of the data be done after trial completion and prior to treatment unblinding, for the purpose of finalizing the planned analysis-in particular, the choice of the statistical model for the primary analysis. However, for Phase III clinical trials especially, the model chosen typically has been used in previous analyses, and assumption checking has already been performed. Thus, at this stage, it may not be necessary, for example, to check the need for a transformation. Further, sensitivity analyses to show the robustness of the planned analysis to the method of handling missing values are typically already included in the analysis plan. In this situation, what types of tests or checks should be included in the blind review? Suggestions for the blind data review reflecting these views are discussed.
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