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This is the preliminary program for the 2009 Joint Statistical
Meetings in Washington, DC.
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The views expressed here are those of the individual authors and not necessarily those of the ASA or its board, officers, or staff. Back to main JSM 2009 Program page |
= Applied Session,
= Theme Session,
= Presenter| CE_14C | Mon, 8/3/09, 8:00 AM - 12:00 PM | RH-Meeting Rooms 12, 13, 14 |
| Methodology for Competing Outcomes: The Analysis of Multiple Mutually Exclusive Endpoints in a Clinical Trial - Continuing Education - Course | ||
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ASA, Biometrics Section |
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| Instructor(s): David C. Naftel, The University of Alabama at Birmingham | ||
| Many clinical trials have a primary endpoint that is actually a composite of several endpoints that can be constructed so they are mutually exclusive. Medical devices that provide mechanically assisted circulatory support often are evaluated on the basis of multiple endpoints, including death, removal of the device due to cardiac transplantation, and removal of the device due to recovery of the heart. A fourth "event" is when the patient is alive with the device in place at a specified time. Estimating the time-related probability of the composite endpoint is important, but rarely sufficient. Clinicians want to understand the simultaneous probabilities of these events. This course will define the problem within a clinical and FDA perspective. Trial design and sample size will be presented. Nonparametric methodological approaches will be presented. Parametric methods that stress the shape of the underlying hazard function will be emphasized. Finally the interactive roles of industry, clinicians, FDA, and the statistician will be defined, interpreted, and presented as a symbiotic structure. | ||
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JSM 2009
For information, contact jsm@amstat.org
or phone (888) 231-3473. If you have questions about the Continuing Education program,
please contact the Education Department. |