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Abstract Details

Activity Number: 89
Type: Roundtables
Date/Time: Monday, July 30, 2012 : 7:00 AM to 8:15 AM
Sponsor: Biopharmaceutical Section
Abstract - #304207
Title: Multiple Testing and Modeling in Post-Market Medical Studies
Author(s): S. Stanley Young*+
Companies: National Institute of Statistical Sciences
Address: P.O. Box 14006, Research Triangle Park, NC, , USA
Keywords: multiple testing ; multiple modeling ; false positives
Abstract:

Post-marketing medical medical studies can have a profound impact on drug sales, yet they can be subject to unintentional (or intentional) manipulation. There is the obvious problem of multiple testing. Suppose 5 drugs are studied. It is a fact that one will appear most dire. Suppose 20 side effects are studied. With 5 drugs and 20 side effects it is a situation ripe for false positives. Something is very likely to be "statistically significant". Observational studies are typically "adjusted" to remove the effects of confounding variables. Each time a variable is moved into or out of the model, the estimated effect of the drug is changed. There is a need to understand how model selection can influence study claims. The purpose of this roundtable is to discuss the degree to which multiple testing and multiple modeling might be a problem and what might be done to address these issues.


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