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Group Sequential and Confirmatory Adaptive Designs in Clinical Trials (Paperback, Softcover reprint of the original 1st ed. 2016)
Loot Price: R4,969
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Group Sequential and Confirmatory Adaptive Designs in Clinical Trials (Paperback, Softcover reprint of the original 1st ed. 2016)
Series: Springer Series in Pharmaceutical Statistics
Expected to ship within 10 - 15 working days
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This book provides an up-to-date review of the general principles
of and techniques for confirmatory adaptive designs. Confirmatory
adaptive designs are a generalization of group sequential designs.
With these designs, interim analyses are performed in order to stop
the trial prematurely under control of the Type I error rate. In
adaptive designs, it is also permissible to perform a data-driven
change of relevant aspects of the study design at interim stages.
This includes, for example, a sample-size reassessment, a
treatment-arm selection or a selection of a pre-specified
sub-population. Essentially, this adaptive methodology was
introduced in the 1990s. Since then, it has become popular and the
object of intense discussion and still represents a rapidly growing
field of statistical research. This book describes adaptive design
methodology at an elementary level, while also considering
designing and planning issues as well as methods for analyzing an
adaptively planned trial. This includes estimation methods and
methods for the determination of an overall p-value. Part I of the
book provides the group sequential methods that are necessary for
understanding and applying the adaptive design methodology supplied
in Parts II and III of the book. The book contains many examples
that illustrate use of the methods for practical application. The
book is primarily written for applied statisticians from academia
and industry who are interested in confirmatory adaptive designs.
It is assumed that readers are familiar with the basic principles
of descriptive statistics, parameter estimation and statistical
testing. This book will also be suitable for an advanced
statistical course for applied statisticians or clinicians with a
sound statistical background.
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