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Activity Number:
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505
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Type:
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Topic Contributed
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Date/Time:
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Wednesday, August 5, 2009 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #304587 |
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Title:
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Statistical Inference and Sample Size Issues for Co-Primary Endpoints in Alzheimer's Disease Trials
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Author(s):
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Mohammad F. Huque*+
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Companies:
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FDA
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Address:
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CDER, Division of Biometrics IV, Room 3510/Bldg 21, Silver Spring, MD, MD 20993,
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Keywords:
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co-primary endpoints ; sample size
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Abstract:
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For a meaningful characterization of treatment benefits, some trials require that treatment efficacy be shown on all specified multiple primary endpoints usually referred to as co-primary endpoints. For example, for Alzheimer's disease trials, clinicians generally characterize meaningful benefit of a new treatment when both the ADAS-Cog and the CIBIC (Clinician's Interview Based Impression of Change) endpoints show statistically significant treatment benefits. However, such clinical efficacy win criteria (i.e., win for efficacy if each of the specified co-primary endpoints shows statistically significant treatment benefit) impacts the Type II error rate and consequently the size of the trial. This presentation will address the statistical inference and sample size determination issues for trials with co-primary endpoints with examples from Alzheimer's disease trials.
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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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