Chapman & Hall/CRC Biostatistics

By: Alex Dmitrienko (Editor), Erik Pulkstenis (Editor)

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22 March 2019 | Edition Number 1

At a Glance

No. of Pages
340

Dimensions(cm)
23.39 x 15.6 x 1.8

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Clinical Trial Optimization Using R explores a unified and broadly applicable framework for optimizing decision making and strategy selection in clinical development, through a series of examples and case studies. It provides the clinical researcher with a powerful evaluation paradigm, as well as supportive R tools, to evaluate and select among simultaneous competing designs or analysis options. It is applicable broadly to statisticians and other quantitative clinical trialists, who have an interest in optimizing clinical trials, clinical trial programs, or associated analytics and decision making.

This book presents in depth the Clinical Scenario Evaluation (CSE) framework, and discusses optimization strategies, including the quantitative assessment of tradeoffs. A variety of common development challenges are evaluated as case studies, and used to show how this framework both simplifies and optimizes strategy selection. Specific settings include optimizing adaptive designs, multiplicity and subgroup analysis strategies, and overall development decision-making criteria around Go/No-Go. After this book, the reader will be equipped to extend the CSE framework to their particular development challenges as well.

Industry Reviews

"The book Clinical Trial Optimization Using R by A. Dmitrienko and E. Pulkstenis gives a comprehensible introduction to the subject of Clinical Scenario Evaluation (CSE) and subsequent optimization . . . The authors present an approach that is easy to understand and to implement in R. The book is well structured, and the underlying principles are described in detail and illustrated by several case studies."
~ Kiana Kreitz, Institute of Biostatistics and Clinical Research, Germany

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