Statistical Issues in Drug Development The revised third edition of
Statistical Issues in Drug Development delivers an insightful
treatment of the intersection between statistics and the life
sciences. The book offers readers new discussions of crucial
topics, including cluster randomization, historical controls,
responder analysis, studies in children, post-hoc tests, estimands,
publication bias, the replication crisis, and many more. This work
presents the major statistical issues in drug development in a way
that is accessible and comprehensible to life scientists working in
the field, and takes pains not to gloss over significant
disagreements in the field of statistics, while encouraging
communication between the statistical and life sciences
disciplines. In addition to new material on topics like invalid
inversion, severity, random effects in network meta-analysis, and
explained variation, readers will benefit from the inclusion of: A
thorough introduction to basic topics in drug development and
statistics, including the role played by statistics in drug
development An exploration of the four views of statistics in drug
development, including the historical, methodological, technical,
and professional An examination of debatable and controversial
topics in drug development, including the allocation of treatments
to patients in clinical trials, baselines and covariate
information, and the measurement of treatment effects Perfect for
life scientists and other professionals working in the field of
drug development, Statistical Issues in Drug Development is the
ideal resource for anyone seeking a one-stop reference to enhance
their understanding of the use of statistics during drug
development.
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