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Activity Number:
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468
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Type:
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Contributed
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Date/Time:
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Wednesday, August 5, 2009 : 10:30 AM to 12:20 PM
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Sponsor:
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SSC
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| Abstract - #303834 |
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Title:
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Weighted Composite Endpoints in the Analysis of Cardiovascular Clinical Trial Data: Addressing an Unmet Need
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Author(s):
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Jeffrey A. Bakal*+ and Cynthia M. Westerhout and Robert C. Welsh and Paul W. Armstrong
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Companies:
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University of Alberta and University of Alberta and University of Alberta and University of Alberta
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Address:
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Rm 331 Environmental Engineering Bldg, Edmonton, AB, T6G 2M8, Canada
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Keywords:
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Survival Analysis ; Clinical Trials ; Outcomes ; Biostatistics ; Weighted Analysis ; cardiology
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Abstract:
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Therapeutic advances have reduced mortality and increased the accrual of nonfatal events in cardiovascular clinical trials. Accordingly, emphasis on composite endpoints has emerged where both fatal and non-fatal events (e.g., heart failure, cardiogenic shock) are typically given equal weight in the analysis of outcomes. Hence an unmet need exists to analyze these data in a clinically meaningful manner. We present a novel analysis which assigns weights relative to perceived impact of the events. These weights are based on a survey tool in which respondents allocated 20 points among 6 events. An advantage of this weighted analysis is that it allows patients experiencing non-fatal outcomes to remain in the cohort for additional follow-up. Examples from an acute myocardial infarction trial will be presented and the implications for trial design and evaluation are discussed.
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