Group Sequential And Confirmatory Adaptive Designs In Clinical Trials (springer Series In Pharmaceutical Statistics)
by Gernot Wassmer /
2016 / English / PDF
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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.
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.
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.
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.