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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 - #305820 |
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Title:
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Providing Evidence of Disease Modification
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Author(s):
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Suzanne Hendrix*+
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Companies:
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Pentara Corporation
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Address:
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2180 E. Claybourne Ave., Salt Lake City, UT, 84109,
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Keywords:
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Disease Modification ; Alzheimer's disease ; Biomarkers ; Slope ; degenerative disease ; Adjusted Slopes
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Abstract:
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Disease modification is affecting the course of a disease process in a way that is permanent. Demonstration of disease modification has been approached with crossover designs, biomarkers or imaging and clinically relevant milestones. An Adjusted Slopes analysis approach uses cross sectional data to separate permanent and temporary effects by estimating longitudinal parameters from a parallel group study. Biomarkers, imaging and clinical milestones intend to directly measure an effect on the disease process but must be validated. Crossover designs often have bias due to high dropout rates. A specific Adjusted Slopes analysis using a mixed model is proposed. It is demonstrated to be a reasonable alternative to crossover designs, biomarkers, imaging or milestones for providing evidence of disease modification. Different analytic approaches could also be used to estimate an Adjusted Slope.
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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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