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Activity Number:
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472
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Type:
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Contributed
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Date/Time:
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Wednesday, August 9, 2006 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #307196 |
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Title:
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The Use of an Internal Unblinded Statistician with a Data-Monitoring Committee
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Author(s):
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David Radley*+ and Gregory Golm
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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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P.O. Box 4, West Point, PA, 19486,
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Keywords:
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data monitoring committee ; unblinded statistician ; internal ; external
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Abstract:
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Phase III clinical trial programs often employ a Data Monitoring Committee (DMC) comprised of experts external to the trial sponsor, to ensure patient safety, oversee trial conduct and perform interim analyses. These committees are served by an unblinded statistician who generates the data summaries for review by the DMC. Many sponsors use external contract personnel to perform this role, and FDA guidance states this arrangement is best for the integrity of the trial. However, there are advantages to using a statistician internal to the sponsor, while the supposed advantages of an external statistician may be less than anticipated. The experiences of internal unblinded statisticians for two major vaccine programs will be described, along with organizational measures taken to ensure independence. We conclude that such a role is viable and is beneficial for the conduct of the trial.
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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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