Abstract Details
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Activity Number:
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554
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Type:
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Roundtables
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Date/Time:
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Wednesday, August 7, 2013 : 12:30 PM to 1:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #308675 |
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Title:
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Understanding Extrinsic Factors in Global Trials: What Culture Means to Biostatisticians
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Author(s):
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Yoko Adachi*+
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Companies:
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FDA
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Keywords:
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multi-regional ;
Geert Hosftede ;
cultural demensions ;
extrinsic factors ;
cross-cultural
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Abstract:
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A 2010 draft EMA reflection paper, titled "Reflection Paper on the Extrapolation of Results from Clinical Studies Conducted Outside the EU to the EU-Population," named country differences in disease definition, medical practice, and demographics of study population for remarkably complicating the interpretation of global trial results. Extrinsic factors such as lifestyle, dietary preferences, and clinical practice impact trial outcomes. When a pharmaceutical trial is conducted in multiple regions, the influence of such extrinsic factors cannot be ignored in drawing inferences about product performance. Understanding of the cultural backgrounds of the study populations would be desirable for facilitating trials in multiple regions and extremely beneficial in explaining trial results. This roundtable will discuss cross-cultural issues and how they can be resolved through communication.
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Authors who are presenting talks have a * after their name.
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