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Clinical Trial Biostatistics and Biopharmaceutical Applications (Hardcover)
Loot Price: R3,727
Discovery Miles 37 270
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Clinical Trial Biostatistics and Biopharmaceutical Applications (Hardcover)
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Since 1945, "The Annual Deming Conference on Applied Statistics"
has been an important event in the statistics profession. In
Clinical Trial Biostatistics and Biopharmaceutical Applications,
prominent speakers from past Deming conferences present novel
biostatistical methodologies in clinical trials as well as
up-to-date biostatistical applications from the pharmaceutical
industry. Divided into five sections, the book begins with emerging
issues in clinical trial design and analysis, including the roles
of modeling and simulation, the pros and cons of randomization
procedures, the design of Phase II dose-ranging trials, thorough
QT/QTc clinical trials, and assay sensitivity and the constancy
assumption in noninferiority trials. The second section examines
adaptive designs in drug development, discusses the consequences of
group-sequential and adaptive designs, and illustrates group
sequential design in R. The third section focuses on oncology
clinical trials, covering competing risks, escalation with overdose
control (EWOC) dose finding, and interval-censored time-to-event
data. In the fourth section, the book describes multiple test
problems with applications to adaptive designs, graphical
approaches to multiple testing, the estimation of simultaneous
confidence intervals for multiple comparisons, and weighted
parametric multiple testing methods. The final section discusses
the statistical analysis of biomarkers from omics technologies,
biomarker strategies applicable to clinical development, and the
statistical evaluation of surrogate endpoints. This book clarifies
important issues when designing and analyzing clinical trials,
including several misunderstood and unresolved challenges. It will
help readers choose the right method for their biostatistical
application. Each chapter is self-contained with references.
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