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Activity Number:
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476
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Type:
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Contributed
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Date/Time:
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Wednesday, August 5, 2009 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #305211 |
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Title:
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Detecting Fraudulent Data in Clinical Trials
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Author(s):
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Bret Musser*+
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Companies:
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Merck Research Laboratories
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Address:
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126 E Lincoln Ave, Rahway, NJ, 07065,
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Keywords:
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clinical trail ; fraud ; clustering
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Abstract:
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The proper conduct of clinical trials is essential for establishing the safety and efficacy of investigational pharmaceutical products. The presence of fraudulent data in a clinical trial undermines the integrity of the entire study and can erode public confidence in the process of scientific research. While most discussions of study misconduct and fraud focus on the role of site-based audits, there may also be a role for careful statistical examinations of the accumulating data to detect specific types of data problems. Motivated by a real example of study misconduct, this talk will discuss statistical techniques that can be used to monitor accumulating data and to assess subjects that appear to be too similar to each other. The talk will also discuss some implications of the use of such tools.
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