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

Shein-Chung Chow (Author), Hansheng Wang (Author), Jun Shao (Author)

Book Description

Publication Date: March 4, 2003 | ISBN-10: 0824709705 | ISBN-13: 978-0824709709 | Edition: 2 Rev Exp

Sample size calculation plays an important role in clinical research. It is not uncommon, however, to observe discrepancies among study objectives (or hypotheses), study design, statistical analysis (or test statistic), and sample size calculation. Focusing on sample size calculation for studies conducted during the various phases of clinical research and development, Sample Size Calculation in Clinical Research explores the causes of discrepancies and how to avoid them.

This volume provides formulas and procedures for determination of sample size required not only for testing equality, but also for testing non-inferiority/superiority, and equivalence (similarity) based on both untransformed (raw) data and log-transformed data under a parallel-group design or a crossover design with equal or unequal ratio of treatment allocations. It contains a comprehensive and unified presentation of statistical procedures for sample size calculation that are commonly employed at various phases of clinical development. Each chapter includes, whenever possible, real examples of clinical studies from therapeutic areas such as cardiovascular, central nervous system, anti-infective, oncology, and women's health to demonstrate the clinical and statistical concepts, interpretations, and their relationships and interactions.

The book highlights statistical procedures for sample size calculation and justification that are commonly employed in clinical research and development. It provides clear, illustrated explanations of how the derived formulas and/or statistical procedures can be used.

Product Details

• Hardcover: 358 pages
• Publisher: CRC Press; 2 Rev Exp edition (March 4, 2003)
• Language: English
• ISBN-10: 0824709705
• ISBN-13: 978-0824709709
• Product Dimensions: 9.4 x 6.4 x 0.8 inches
• Shipping Weight: 1.2 pounds
• Average Customer Review: 3.3 out of 5 stars  See all reviews (3 customer reviews)
• Amazon Best Sellers Rank: #2,603,098 in Books (See Top 100 in Books)

Customer Reviews

Most Helpful Customer Reviews

30 of 30 people found the following review helpful:

4.0 out of 5 stars sample size an important aspect of trial design, February 6, 2008

By 

Michael R. Chernick "statman31147" (Holland PA) - See all my reviews
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This review is from: Sample Size Calculations in Clinical Research (Chapman & Hall/CRC Biostatistics Series) (Hardcover)

The authors of this book have a great deal of clinical trial experience in the pharmaceutical industry as well as strong academic backgrounds. For the clinical trial statistician there is now a rich supply of software products to aid in the determination of sample size for a variety of modeling situations. So knowing formulas is no longer important. What is important is to understand the basis for the formulas. This book provides the industrial perspective and the main fixed sample size designs. In this industry trials are constructed to show superiority, noninferiority and equivalence. These three distinct appoaches lead to different results because the null and alternative hypotheses change as you change your goal from superiority to equivalence.

This book makes that important distinction and is very scholarly, providing many of the relevant references. Although most clinical trials are still parallel design randomized controlled trials with fixed sample size, there are more and more trials that allow for sequential decisionmaking and hence the actual total sample size can be subject to randomness. The group sequential trials have been the most successful in this regard. But now there are also more flexible "adaptive designs" that are being used. For group sequential designs see the text by Jennison and Turnbull and for the adaptive designs Chow and Chang and a more recent applied text by Chang are very good sources of information. Software packages that are available to do group sequential and adaptive designs are East by Cytel, Seq+Trials by Insightful Corp., PASS by Number Crunchersand ADDPLAN by a German Company. Also statisticians like Mark Chang and Keaven Anderson have created their own routines for adaptive designs using the R programming language.

16 of 16 people found the following review helpful:

3.0 out of 5 stars This *could* have been great..., April 24, 2006

By 

Mitchell Maltenfort "biomedical engineer" (Philadelphia, PA USA) - See all my reviews
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This review is from: Sample Size Calculations in Clinical Research (Chapman & Hall/CRC Biostatistics Series) (Hardcover)

At first browse, this book looks a bit like one of Julius Bendat's excellent texts on time series analysis: dense in formulas, but rewarding the wade.

And then I tried to actually _work through_ their examples. A formula-rich book is NO place for typos.

I don't mind when the text uses "lossed" for "lost;" I can quickly figure out what was meant. I resent having to do forensics to rebuild what formulas and/or results I should have seen in the examples.

That three-star rating reflects two things: the potential this book could have had, and my expectation that sooner or later there will be an ERRATA listing that helps sort this beast out.

11 of 11 people found the following review helpful:

3.0 out of 5 stars A reasonable reference book, but my expectations were higher, August 8, 2007

By 

Oleksandr Sverdlov "statistician" (Princeton NJ) - See all my reviews
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This review is from: Sample Size Calculations in Clinical Research (Chapman & Hall/CRC Biostatistics Series) (Hardcover)

I am a PhD statistician working in a pharma company. My overall impression about this book is that it is not a handbook for use on a daily basis for clinical trialists. I expected the book to be more insightful about sample size calculations. Examples are very artificial, not taken from real-life.

The book has an academic flavor, however the intended audience is clinical trials practicioners. It would be much better to start each chapter with a couple of strong examples, then description of the methodology, and finally sample size calculations.

I think this book needs a lot of improvement before it can be used as a good reference