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Activity Number:
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296
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Type:
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Roundtables
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Date/Time:
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Tuesday, July 31, 2007 : 12:30 PM to 1:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #308229 |
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Title:
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Statistical Analysis Plans: How, When, Why, and for Whom Do We Do Them?
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Author(s):
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Bruce Binkowitz*+
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Companies:
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Merck & Co., Inc.
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Address:
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18 Bates Way, Westfield, NJ, 07090,
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Keywords:
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ICH E9 ; analysis ; plan
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Abstract:
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Statistical analysis plans (SAPs) are suggested by guidance (e.g., ICH E9) as appropriate documents for prespecifying statistical methodology and data handling rules. These analysis plans should be completed prior to the unblinding of a database. This roundtable is intended to discuss why we write these documents, who the target audiences and reviewers are, when in the lifecycle of a trial do we write these, are they really necessary, and how easy/difficult they are to put together.
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- The address information is for the authors that have a + after their name.
- Authors who are presenting talks have a * after their name.
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