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Activity Number:
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607
- Recent Advances in Missing Data Methods: From Estimands to Assumptions for Primary and Sensitivity Analyses
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Type:
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Topic Contributed
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Date/Time:
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Thursday, August 3, 2017 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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Abstract #322674
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View Presentation
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Title:
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Overview of Estimands, Estimators, and Sensitivity for 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 & Co.
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Keywords:
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missing data ;
estimands ;
clinical trials
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Abstract:
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Recent research has fostered new guidance on preventing and treating missing data. Consensus exists that clear objectives should be defined along with the causal estimands; trial design and conduct should maximize adherence to the protocol specified interventions; and, a sensible primary analysis should be used along with plausible sensitivity analyses. Two general categories of estimands are: effects of the drug as actually taken (de-facto, effectiveness) and effects of the drug if taken as directed (de-jure, efficacy). Fundamental, design, and analysis considerations for common estimands will be discussed. Examples are used to illustrate the benefit from assessing multiple estimands in the same study. General approaches to sensitivity analyses will be introduced and subsequent speakers in this session will elaborate on specific approaches.
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Authors who are presenting talks have a * after their name.
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