Sample Size Calculations in Clinical Research, Second Edition (Chapman & Hall/CRC Biostatistics Series)

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Focusing on an integral part of pharmaceutical development, Sample Size Calculations in Clinical Research, Second Edition presents statistical procedures for performing sample size calculations during various phases of clinical research and development. It provides sample size formulas and procedures for testing equality, noninferiority/superiority, and equivalence. A comprehensive and unified presentation of statistical concepts and practical applications, this book highlights the interactions between clinicians and biostatisticians, includes a well-balanced summary of current and emerging clinical issues, and explores recently developed statistical methodologies for sample size calculation. Whenever possible, each chapter provides a brief history or background, regulatory requirements, statistical designs and methods for data analysis, real-world examples, future research developments, and related references. One of the few books to systematically summarize clinical research procedures, this edition contains new chapters that focus on three key areas of this field. Incorporating the material of this book in your work will help ensure the validity and, ultimately, the success of your clinical studies.

Sample Size Calculations in Clinical Research, Second Edition (Chapman & Hall/CRC Biostatistics Series) Review

This is the second edition of a very popular book on sample size estimation that is a valuable reference for any statistician in the industry. we all need to go through such expercises at the beginning of a trial as part of the protocol development.

One disappointment I have with the book is that it does not delineate new topics and other changes/additions from the first edition. Often this is covered by having two Prefaces, the original one from the first edition and a new one from the second edition. The authors unfortunately did not choose to do that. So an owner of the first edition would have to scan through both books to identify the changes.

Another disappointment is the lack of reference to any existing software to do sample size estimation and these days there are a lot of products available. The programs nQuery Advisor and Power and Precision handle equivalence, superiority and noninferiority problems for continuous data. They also provide approximate and exact methods for binomial data. Other packages such as StatXact handle sample size estimation for exact binomial tests as well as for Fisher's Exact test. PASS, S+SeqTrial and East are packages that provide the designs and sample size stopping rules for group sequential procedures and in some cases adaptive designs. Also with the development of version 9 of SAS comes the new procedures power and glmpower that do everything that nQuery can handle.

The value of the book is that it develops the methodology and therefore helps with the understanding of how and when to use the various procedures. Traditional tables that use to be important for sample size calculations are now obsolete given the availability of good software tools. Although the book goes to great lengths to cover almost any application. Most of these applications can be handled these days through the available software packages.

I can definitely recommend this book as a fine reference on sample size estimation for the wide range of trial applications. I would only try to encourage the authors to drop the use of tables and get up to date by recommending the appropriate software for the various applications.

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