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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 - #300826 |
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Title:
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Role of Statisticians and Programmers in Assessment of Safety
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Author(s):
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Vipin Arora*+
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Companies:
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Global Biostatistics and Data Management
Abbott Laboratories
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Address:
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Director, Statistics, Abbott Park, IL, 60064, USA
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Keywords:
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Safety ;
Pooled analysis ;
Statisticians ;
Programmers
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Abstract:
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In Pharmaceutical industry, there is an increased awareness to monitor safety in view of changing regulatory landscape. It is critical that statisticians (and programmers) collaborate early on with Clinical and Safety teams to propose and finalize collection of safety data from an individual study and plan to pool the safety data across various indications (ie not limited to one submission or expansion of an existing label). Wherever possible, statistical assessments in terms of power and related measures should also be provided to stake holders to increase awareness of including a specific analysis at a study level versus the corresponding analysis at the pooled level. Examples of such collaboration(s) will be shared at the round table luncheon alongwith optimal ways of integrating and presenting safety data.
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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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