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

Shein-Chung Chow (Author), Hansheng Wang (Author), Jun Shao (Author)
3.5 out of 5 stars  See all reviews (2 customer reviews)

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Book Description

1584889829 978-1584889823 August 22, 2007 2
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.


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Editorial Reviews

Review

"… an excellent resource, and the added material (which amounts to roughly 100 pages) more than justifies the publication of the second edition."
—Joseph Cavanaugh, University of Iowa, Journal of the America Statistical Association, March 2009

"The second edition book presents on a total of 465 pages a comprehensive derivation of sample size formulae for a wide variety of testing scenarios from many different clinical research topics … well written and easy to read due to the uniform organizational structure of all chapters. Each chapter contains a detailed description of the statistical test problems, the adequate statistical formulae for sample size calculations, numerical examples as well as practical issues … this book is recommended to biostatisticians and clinical scientists in medical or pharmaceutical research and provides a comprehensive reference of sample size calculations covering a wide range of different clinical research topics."
—Iris Burkholder, Zentralblatt MATH, 2009

"…The second edition has been carefully updated from the first edition. … One of the strengths of the book is the organizational structure. Each chapter contains comprehensive references, examples, and practical considerations. The book is clearly laid out and easy to read. The table of contents and the index are comprehensive, which makes the book quite useful as a reference. … In summary, this is a useful, comprehensive compendium of almost every possible sample size formula. The strong organization and carefully defined formulae will aid any researcher designing a study."
Biometrics, December 2008

“This impressive book contains formulae for computing sample size in a wide range of settings. One-sample studies and two-sample comparisons for quantitative, binary, and time-to-event outcomes are covered comprehensively, with separate sample size formulae for testing equality, non-inferiority, and equivalence. Many less familiar topics are also covered, including sample size for comparing k samples, bioequivalence, dose–response studies, and (new in this second edition) microarray studies and Bayesian sample size determination. … Overall, this is a useful reference for the mathematical statistician …”
—Ian White (Medical Research Council Biostatistics Unit), Journal of the Royal Statistical Society

"… The book is well written and easy to read. … a useful comprehensive reference of sample size calculation procedures for clinical research. It should be a valuable reference book for biostatisticians and clinical scientists in medical or pharmaceutical research."
Statistics in Medicine, 2008

"This book gives excellent coverage to the many types of study design and aims that are likely to be encountered. The main strength of the book is the vast collection of sample size calculations from many different areas of clinical research … an excellent reference for people involved in the designing of clinical research projects."
The Journal of Perioperative Practice, September 2008

"…This text provides procedures and formulae for the determination of sample size and the appropriate calculation of power for the hypotheses that reflect study objectives under a valid study design. … this second edition will appeal to both practitioners and students alike."
International Statistical Review, 2008

Praise for the First Edition
“This well-composed book … contains sample size formulas and examples. … a good reference book for researchers in clinical trials.”
Journal of Statistical Computation and Simulation, Vol. 74, No. 5, May 2004

“The reference list contains details of an excellent collection of articles. The examples are clearly illustrated. This is a fascinating book, and applied statisticians and health and medical researchers will like it a lot. Statistical consultants will be fond of the book as a reference guide.”
Journal of Statistical Computation and Simulation, Vol. 75, No. 9, September 2005


Product Details

  • Hardcover: 480 pages
  • Publisher: Chapman and Hall/CRC; 2 edition (August 22, 2007)
  • Language: English
  • ISBN-10: 1584889829
  • ISBN-13: 978-1584889823
  • Product Dimensions: 9.3 x 6.4 x 1.2 inches
  • Shipping Weight: 1.8 pounds (View shipping rates and policies)
  • Average Customer Review: 3.5 out of 5 stars  See all reviews (2 customer reviews)
  • Amazon Best Sellers Rank: #266,803 in Books (See Top 100 in Books)

 

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29 of 31 people found the following review helpful:
4.0 out of 5 stars nice coverage of typical sample size problems in clinical trials, September 4, 2007
This review is from: Sample Size Calculations in Clinical Research, Second Edition (Chapman & Hall/CRC Biostatistics Series) (Hardcover)
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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9 of 9 people found the following review helpful:
3.0 out of 5 stars Requires editing, February 19, 2008
This review is from: Sample Size Calculations in Clinical Research, Second Edition (Chapman & Hall/CRC Biostatistics Series) (Hardcover)
I found the errors in the book absolutely infuriating! Many typos in the text from the first edition are maintained in the second edition. The typos in both text and formulas in the expanded information in the second edition together with gaps in the development of the information made it necessary to consult other sources to figure out what's going on.
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Inside This Book (learn more)
Key Phrases - Statistically Improbable Phrases (SIPs): (learn more)
comparing variabilities, microarray studies, false discovery rate, comparing total variabilities, propensity analysis, conditional power, bioequivalence testing, test for minimum effective dose, unequal treatment allocation, recording replicates, nonprofile analysis, posterior error rate, sample size per treatment group, size calculation formula, constant effect sizes, worst outcome criterion, procedures for sample size calculation, prognostic genes, ith treatment group, ignoring strata, replicated crossover design, reproducibility probability, active control agent, formulas for sample size calculation, superiority margin
Key Phrases - Capitalized Phrases (CAPs): (learn more)
Practical Issues, Considerations Prior, Other Areas, Posterior Credible Interval Approach, Two-Sided Tests, Family-wise Error Rate, Critical Values, Comparing Time-to-Event Data, Two-Sample Crossover Design, Central Limit Theorem, Comparing Means, One-Sample Design, Dose Response Studies, Comparing Inter-Subject Variabilities, Optimal Three-Stage Designs, Time-Dependent Replicates, Superiority Similar, Number of Dose Levels, Concluding Remarks, Multiple-Sample One-Way, Basic Considerations, Non-Randomized Studies, Large Sample Tests
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