Estimands, Estimators and Sensitivity Analysis in Clinical Trials

1st Edition

Craig Mallinckrodt, Geert Molenberghs, Ilya Lipkovich, Bohdana Ratitch

Chapman and Hall/CRC
December 23, 2019 Forthcoming
Reference - 312 Pages - 20 B/W Illustrations
ISBN 9781138592506 - CAT# K386970
Series: Chapman & Hall/CRC Biostatistics Series

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Summary

The concepts of estimands, analyses (estimators) and sensitivity are interrelated. Therefore, great need exists for an integrated approach to these topics. This book acts as a practical guide to developing and implementing statistical analysis plans by explaining fundamental concepts using accessible language; providing technical details; providing real world examples and providing SAS and R code to implement analyses. The updated ICH guideline raises new analytic and cross-functional challenges for statisticians. Gaps between different communities have come to surface, such as between causal inference and clinical trialists, as well as between clinicians, statisticians, and regulators when it comes to communicating decision-making objectives, assumptions, and interpretations of evidence.

This book lays out a path towards bridging some of these gaps. It offers:

  • a common language and unifying framework along with the technical details and practical guidance to help statisticians meet the challenges;

  • a thorough treatment of intercurrent events (ICEs), i.e., post-randomization events that confound interpretation of outcomes, and five strategies for ICEs in ICH E9 (R1);

  • details on how estimands, integrated into a principled study development process, lay a foundation for coherent specification of trial design, conduct, and analysis needed to overcome the issues caused by ICEs;

  • a perspective on the role of the intention-to-treat principle;

  • examples and case studies from various areas;

  • example code in SAS and R;

  • a connection with causal inference;

  • implications and methods for analysis of longitudinal trials with missing data.

Jointly, the authors have offered the readers their ample expertise in clinical trial design and analysis, from an industrial as well as academic perspective.

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