This book gives the reader important accounts of basic statistical procedures used in clinical trials. It covers several areas of study, including biostatics, biomathematics, biometry and epidemiology. There is emphasis for trialists to learn good methodology while giving quality clinical treatment. Discusses and explores controversial issues such as ethics and offers pragmatic information regarding allegations of fraud or misconduct.
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Book Description
Editorial Reviews
Review
"…clearly written, practical presentations of the standard topics, and also fascinating discussion you won't find elsewhere…" (Journal of Clinical Research Best Practices, August 2007)
"…a very good addition to the clinical trials area." (Statistical Methods in Medical Research, October 2006)
"…an excellent reference for both clinicians and statisticians." (Journal of Biopharmaceutical Statistics, May/June 2006) --This text refers to an alternate Hardcover edition.
From the Publisher
This book gives the reader important accounts of basic statistical procedures used in clinical trials. It covers several areas of study, including biostatics, biomathematics, biometry and epidemiology. There is emphasis for trialists to learn good methodology while giving quality clinical treatment. Discusses and explores controversial issues such as ethics and offers pragmatic information regarding allegations of fraud or misconduct.
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Most Helpful Customer Reviews
31 of 31 people found the following review helpful:
5.0 out of 5 stars
unusually well-written text on the statistical aspects,
By
This review is from: Clinical Trials: A Methodologic Perspective Second Edition(Wiley Series in Probability and Statistics) (Hardcover)
This book is very unique. Basic statistical concepts are clearly presented but only those concepts that are important in clinical trials. The author presents all the issues with clinical trials including ethical issues with some historical perspective. Principles of randomization and statistical design are clearly presented. It offers discussion of Bayesian techniques and meta-analyses, cross-over designs and group sequential methods (interim analyses). For statisticians doing clinical research like myself, this is a valuable reference source.
20 of 20 people found the following review helpful:
5.0 out of 5 stars
The best start in clinical trial,
This review is from: Clinical Trials: A Methodologic Perspective (Hardcover)
The amount of knowledge and the scope of this book are the exact need for the first contact with clinical trials. Yet, it is not a simple or superficial text. Instead, it not only will guide the reader through the basics of trials (and there is so much that is not basic in it) but the author points the reader to hundreds of papers and books that are landmarks. I regard this book itself as one of these landmarks!
16 of 16 people found the following review helpful:
5.0 out of 5 stars
Most up-to-date and thorough cover of Clinical Trials,
By A Customer
This review is from: Clinical Trials: A Methodologic Perspective (Hardcover)
Covers many aspects of trials (particularly facets of design and analysis)not yet covered by other books, eg randomisation with minimisation, and meta-analysis of trial results. Readable, applicable, practical, good references, well structured.
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Inside This Book
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First Sentence:
The best time to contemplate the quality of evidence from a clinical trial is before it begins. Read the first page Key Phrases - Statistically Improbable Phrases (SIPs): (learn more)
trial methodologists, prognostic factor analyses, nitro weeks, endpoint ascertainment, active ascertainment, developmental trials, lung cancer clinical trial, true hazard ratio, continual reassessment method, relative treatment effects, uncounted events, stopping guidelines, ineligible patients, constrained randomization, reporting trial results, adaptive randomization, definitive endpoint, binomial confidence limits, disease prevention studies, incomplete factorial designs, clinical trials literature, data imperfections, clinical landmark, sample size equations, true treatment effect Key Phrases - Capitalized Phrases (CAPs): (learn more)
New York, John Wiley, New Engl, Oxford University Press, Controlled Clin, Office of Research Integrity, Public Health Service, United States, National Academy of Sciences, Second Edition, National Cancer Institute, National Science Foundation, Cambridge University Press, Coronary Drug Project, Biopharmaceutical Statistics, Marcel Dekker, Great Britain, National Institutes of Health, Office of the General Counsel, Press Office, Standards of Reporting Trials Group, World Medical Association, Advisory Board of the Medical Faculty, Event Age Race Elig Wt Sex, Institutional Review Board New!
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Front Cover | Table of Contents | First Pages | Index | Back Cover | Surprise Me!
The best time to contemplate the quality of evidence from a clinical trial is before it begins. Read the first page Key Phrases - Statistically Improbable Phrases (SIPs): (learn more)
trial methodologists, prognostic factor analyses, nitro weeks, endpoint ascertainment, active ascertainment, developmental trials, lung cancer clinical trial, true hazard ratio, continual reassessment method, relative treatment effects, uncounted events, stopping guidelines, ineligible patients, constrained randomization, reporting trial results, adaptive randomization, definitive endpoint, binomial confidence limits, disease prevention studies, incomplete factorial designs, clinical trials literature, data imperfections, clinical landmark, sample size equations, true treatment effect Key Phrases - Capitalized Phrases (CAPs): (learn more)
New York, John Wiley, New Engl, Oxford University Press, Controlled Clin, Office of Research Integrity, Public Health Service, United States, National Academy of Sciences, Second Edition, National Cancer Institute, National Science Foundation, Cambridge University Press, Coronary Drug Project, Biopharmaceutical Statistics, Marcel Dekker, Great Britain, National Institutes of Health, Office of the General Counsel, Press Office, Standards of Reporting Trials Group, World Medical Association, Advisory Board of the Medical Faculty, Event Age Race Elig Wt Sex, Institutional Review Board New!
Books on Related Topics | Concordance | Text Stats Browse Sample Pages:
Front Cover | Table of Contents | First Pages | Index | Back Cover | Surprise Me!
Citations (learn more)
This book cites 22
books:
See all 22 books this book cites
100
books
cite this book:
See all 100 books citing this book
- Introducing New Treatments for Cancer: Practical, Ethical and Legal Problems by C. J. Williams on 6 pages
- Advanced Theory of Statistics, Vol. 3 by M. G. Kendall on 4 pages
- Statistical Methods in Medical Research (Armitage, Statistical Methods in Medical Research) by Peter Armitage on 4 pages
- Statistics in Medical Research: Methods and Issues With Applications in Cancer Research (Wiley Series in Probability and Statistics) by Valerie Mike on page 267, page 361, and Back Matter
- The Statistical Analysis of Failure Time Data (Wiley Series in Probability and Statistics) by John D. Kalbfleisch on page 331, and Back Matter
See all 22 books this book cites
- Statistical Monitoring of Clinical Trials: Fundamentals for Investigators by Lemuel A. Moyé on page 29, page 50, and page 110
- Statistical Models and Methods for Lifetime Data (Wiley Series in Probability and Statistics) by Jerald F. Lawless in Back Matter (1), and Back Matter (2)
- Multiple Analyses in Clinical Trials: Fundamentals for Investigators (Statistics for Biology and Health) by Lemuel A. Moyé on page 45, and page 238
- Recent Advances in Quantitative Methods in Cancer and Human Health Risk Assessment (Wiley Series in Probability and Statistics) by Lutz Edler in Back Matter (1), and Back Matter (2)
- Statistical Size Distributions in Economics and Actuarial Sciences (Wiley Series in Probability and Statistics) by Christian Kleiber in Back Matter
See all 100 books citing this book
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