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Books > Medicine > General issues > Public health & preventive medicine > Epidemiology & medical statistics
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Estimands, Estimators and Sensitivity Analysis in Clinical Trials (Hardcover)
Loot Price: R3,595
Discovery Miles 35 950
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Estimands, Estimators and Sensitivity Analysis in Clinical Trials (Hardcover)
Series: Chapman & Hall/CRC Biostatistics Series
Expected to ship within 12 - 19 working days
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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, real-world examples, and 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 among
clinicians, statisticians, and regulators when it comes to
communicating decision-making objectives, assumptions, and
interpretations of evidence. This book lays out a path toward
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., postrandomization
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 Together, the authors have offered the
readers their ample expertise in clinical trial design and
analysis, from an industrial and academic perspective.
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