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Abstract Details
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Activity Number:
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365
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Type:
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Roundtables
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Date/Time:
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Tuesday, August 2, 2011 : 12:30 PM to 1:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #301305 |
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Title:
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Small Event Rates, Big Outcome Studies
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Author(s):
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Jennifer E. Hamer-Maansson*+
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Companies:
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AstraZeneca
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Address:
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1800 Concord Pike, Wilmington, DE, 19810, USA
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Keywords:
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small event rates ;
outcome studies ;
relative risk ;
absolute risk ;
diabetes ;
asthma
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Abstract:
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The FDA now requires a sponsor to exclude a certain level of risk of certain safety concerns for select classes of compounds. For example, all diabetes treatments must exclude a certain level of risk of the compound versus all comparators for cardiovascular events and long acting beta agonists (LABAs) must exclude a certain level of risk for asthma exacerbations. The small event rates for certain safety events can make these outcome studies rather large. We will discuss the issues associated with these studies (sample size, non-inferiority margins, relative risk versus absolute risk, recruitment issues, cost, populations to be studied, choice of active or placebo control, etc.).
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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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