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Sample Size Calculations in Clinical Research (Biostatistics, 11)
Binding: Hardcover
Dewey Decimal Number: 310
EAN: 9780824709709
Edition: 1
ISBN: 0824709705
Label: CRC
Manufacturer: CRC
Number Of Items: 1
Number Of Pages: 358
Publication Date: March 04, 2003
Publisher: CRC
Studio: CRC
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Editorial Review: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.
Customer Reviews
Average Rating: 
Rating:  - sample size an important aspect of trial design
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. ... Read More
Rating:  - A reasonable reference book, but my expectations were higher
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 ... Read More
Rating: - This *could* have been great...
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 ... Read More
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