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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 (Paperback)
Loot Price: R1,509
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Estimands, Estimators and Sensitivity Analysis in Clinical Trials (Paperback)
Series: Chapman & Hall/CRC Biostatistics Series
Expected to ship within 12 - 17 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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