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Activity Number:
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329
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Type:
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Roundtables
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Date/Time:
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Tuesday, August 4, 2009 : 12:30 PM to 1:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #304108 |
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Title:
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Subgroup Analysis: Cost and Ethical Considerations
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Author(s):
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Terri K. Johnson*+
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Companies:
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FDA
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Address:
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1350 Piccard Drive, HFZ-550, Rockville, MD, 20850,
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Keywords:
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subgroup anaysis
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Abstract:
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When there are apparent differences between groups, conducting a randomized clinical trial (RCT) for each group independently maybe desirable in order to ensure safety and effectiveness of the patient population. However, it may discourage private companies to develop drugs/devices for illness that imposes such requirement perhaps due to high cost. What may be, if any, an alternate study design, i.e. requires less sample size than RCT by group, that would not compromise the safety and efficacy of the public.
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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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