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Activity Number:
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43
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Type:
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Invited
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Date/Time:
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Sunday, August 2, 2009 : 4:00 PM to 5:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #303221 |
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Title:
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The Use of Responder Analyses in Regulatory Guidance and Professional Society Guidelines
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Author(s):
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Leonard Oppenheimer*+ and Zhongxin (John) Zhang
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Companies:
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Johnson & Johnson PRD and Johnson & Johnson PRD
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Address:
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920 Route 202, PO Box 300, Raritan, NJ, 08869-0602,
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Keywords:
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Abstract:
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A responder analysis, based on the proportion of subjects exceeding or declining beyond a specified threshold of either the original variable or change/ratio from baseline, is commonly recommended in regulatory guidance. Both FDA and EMEA specifically endorse the responder analysis to assess the treatment effect of an experimental drug in clinical trials (ICH E9; EMEA (CPMP/EWP/2158/99); ICH E10). One critical issue in regulatory guidance documents is to distinguish the difference between statistical significance and a clinically relevant effect. For this reason the term "responder" (and "non-responder") is used to express the clinical benefit of treatment to individual patients, and also becomes a standard in Practice Guidelines For Primary Care physicians. In this talk, we will provide examples of responder analyses as the primary/co-primary or secondary analyses.
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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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