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12 - The Analytic Road Map

Published online by Cambridge University Press:  05 February 2013

Craig H. Mallinckrodt
Affiliation:
Eli Lilly and Company, Indianapolis, IN
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Summary

Introduction

The previous chapter illustrated estimands and common analytic approaches to estimate them. No matter how careful the choice of estimand and analysis, assumptions about the missing data are hard to avoid and it is important to understand the robustness of inferences to the assumptions. Such assessments can be made using sensitivity analyses.

Principles and methods for sensitivity analyses that quantify the robustness of inferences to departures from underlying assumptions is an emerging area of statistical science.

Because it is an active area of research, consensus does not exist on exactly how sensitivity analyses should be conducted and interpreted. However, the recent NRC guidance on prevention and treatment of missing data set forth principles and described methods consistent with those principles (NRC, 2010). The ideas presented in the NRC guidance are largely consistent with proposals and general ideas from Molenberghs and Kenward (2007) and Mallinckrodt et al. (2008). The methods and principles outlined in this chapter are a consolidated view of these recent recommendations.

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Publisher: Cambridge University Press
Print publication year: 2013

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  • The Analytic Road Map
  • Craig H. Mallinckrodt
  • Book: Preventing and Treating Missing Data in Longitudinal Clinical Trials
  • Online publication: 05 February 2013
  • Chapter DOI: https://doi.org/10.1017/CBO9781139381666.017
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  • The Analytic Road Map
  • Craig H. Mallinckrodt
  • Book: Preventing and Treating Missing Data in Longitudinal Clinical Trials
  • Online publication: 05 February 2013
  • Chapter DOI: https://doi.org/10.1017/CBO9781139381666.017
Available formats
×

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To save content items to your account, please confirm that you agree to abide by our usage policies. If this is the first time you use this feature, you will be asked to authorise Cambridge Core to connect with your account. Find out more about saving content to Google Drive.

  • The Analytic Road Map
  • Craig H. Mallinckrodt
  • Book: Preventing and Treating Missing Data in Longitudinal Clinical Trials
  • Online publication: 05 February 2013
  • Chapter DOI: https://doi.org/10.1017/CBO9781139381666.017
Available formats
×