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Abstract Details
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Activity Number:
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56
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Type:
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Invited
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Date/Time:
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Sunday, July 31, 2011 : 4:00 PM to 5:50 PM
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Sponsor:
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Leadership Support Council
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| Abstract - #300423 |
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Title:
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Challenges in the FDA Statistical Reviews of Submissions Containing Patient-Reported Outcomes (PROs)
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Author(s):
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Lisa A. Kammerman*+
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Companies:
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U.S. Food and Drug Administration
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Address:
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Office of Biostatistics - Center for Drug Evaluation and Research, Silver Spring, MD, 20993, USA
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Keywords:
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patient-reported outcomes ;
FDA ;
PROs ;
case studies ;
regulatory review
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Abstract:
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Although FDA's guidance on patient-reported outcomes (PROs) provides advice on the quantitative and statistical aspects of PROs and the data they generate, their review by FDA statisticians presents many challenges. I will present recent case studies that illustrate some of the challenges related to the validation of instruments and the interpretation of results from studies that use PROs. These case studies also identify areas that require further thought and development.
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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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