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Activity Number:
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521
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Type:
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Invited
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Date/Time:
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Thursday, August 2, 2007 : 10:30 AM to 12:20 PM
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Sponsor:
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Statisticians in the Pharmaceutical Industry
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| Abstract - #307685 |
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Title:
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Choice of the Primary Analysis in Longitudinal Clinical Trials
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Author(s):
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Craig Mallinckrodt*+
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Companies:
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Eli Lilly and Company
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Address:
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Lilly Corporate Center, Indianapolis, IA, 46285,
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Keywords:
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missing data ; longitudinal data ; clinical trials
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Abstract:
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The last observation carried forward (LOCF) approach is often used to handle missing data. Advances in methodology and its implementation have made likelihood- and Bayesian-based approaches easy to implement and they are commonly used. Research has unequivocally demonstrated that these approaches are more robust to the biases from missing data and provide better control of Type I and Type II errors than LOCF. The supposed conservative behavior of LOCF is never guaranteed and is often unlikely. Furthermore, using LOCF as a composite measure of safety, tolerability and efficacy can lead to erroneous conclusions regarding the effectiveness of a drug. Although practice is shifting away from LOCF, regulatory acceptance of alternative approaches is slow. Greater acceptance of MAR-based approaches is needed to improve the efficiency and effectiveness of drug development.
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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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