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Statistics Applied to Clinical Trials

  • Book
  • © 2009

Overview

Editors:
  1. Ton J. Cleophas

    1. Albert Schweitzer Hospital, Dordrecht, The Netherlands

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  2. Aeilko H. Zwinderman

    1. Academic Medical Center, Amsterdam, The Netherlands

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    You can also search for this editor in PubMed   Google Scholar

  3. Toine F. Cleophas

    1. Damen Shipyards, Gorinchem, The Netherlands

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  4. Eugene P. Cleophas

    1. Technical University, Delft, The Netherlands

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  • The authors have both medical and mathematical backgrounds
  • Based on famous modules from the Socrates educational project Eudipharm of the EC
  • Innovative because of the explanatory rather than mathematical approach
  • Emphasizes non-classical but increasingly frequently used methods such as equivalence testing, interaction assessment and analysis of genetic data
  • Not equivalent to any current textbook on statistics

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Table of contents (47 chapters)

  1. Front Matter

    Pages i-xxi
    Download chapter PDF

  2. Hypotheses, Data, Stratification

    Pages 1-16

  3. The Analysis Of Efficacy Data

    Pages 17-43

  4. The Analysis of Safety Data

    Pages 45-62

  5. Log Likelihood Ratio Tests For Safety Data Analysis

    Pages 63-71

  6. Equivalence Testing

    Pages 73-79

  7. Statistical Power And Sample Size

    Pages 81-97

  8. Interim Analyses

    Pages 99-105

  9. Controlling The Risk of False Positive Clinical Trials

    Pages 107-111

  10. Multiple Statistical Inferences

    Pages 113-122

  11. The Interpretation of The P-Values

    Pages 123-135

  12. Research Data Closer To Expectation Than Compatible With Random Sampling

    Pages 137-143

  13. Statistical Tables For Testing Data Closer To Expectation Than Compatible With Random Sampling

    Pages 145-153

  14. Principles Of Linear Regression

    Pages 155-156

  15. Subgroup Analysis Using Multiple Linear Regression: Confounding, Interaction, Synergism

    Pages 175-184

  16. Curvilinear Regression

    Pages 185-197

  17. Logistic and Cox Regression, Markow Models, Laplace Transformations

    Pages 199-220

  18. Regression Modeling for Improved Precision

    Pages 221-227

  19. Post-Hoc Analyses in Clinical Trials, a Case for Logistic Regression Analysis

    Pages 229-234

  20. Confounding

    Pages 235-244
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Keywords

About this book

In clinical medicine appropriate statistics has become indispensable to evaluate treatment effects. Randomized controlled trials are currently the only trials that truly provide evidence-based medicine. Evidence based medicine has become crucial to optimal treatment of patients. We can define randomized controlled trials by using Christopher J. Bulpitt’s definition “a carefully and ethically designed experiment which includes the provision of adequate and appropriate controls by a process of randomization, so that precisely framed questions can be answered”. The answers given by randomized controlled trials constitute at present the way how patients should be clinically managed. In the setup of such randomized trial one of the most important issues is the statistical basis. The randomized trial will never work when the statistical grounds and analyses have not been clearly defined beforehand. All endpoints should be clearly defined in order to perform appropriate power calculations. Based on these power calculations the exact number of available patients can be calculated in order to have a sufficient quantity of individuals to have the predefined questions answered. Therefore, every clinical physician should be capable to understand the statistical basis of well performed clinical trials. It is therefore a great pleasure that Drs. T. J. Cleophas, A. H. Zwinderman, and T. F. Cleophas have published a book on statistical analysis of clinical trials. The book entitled “Statistics Applied to Clinical Trials” is clearly written and makes complex issues in statistical analysis transparant.

Reviews

From the reviews of the fourth edition:

"Readership: Students, physicians and investigators interested in statistical methods for clinical trials. This book was originally written for a course in medical statistics given in the EU sponsored program European Interuniversity Diploma of Pharmaceutical Medicine starting in the year 2000. … it has been expanded and updated in order to serve as a guide and reference-text to students, physicians and investigators." (Andreas Rosenblad, International Statistical Review, Vol. 77 (3), 2009)

“The book is written for students in health care and physicians and can be viewed as a guide and reference textbook. … an important contribution to the clinical trials and medical statistics community. … The book’s main strength is its presentation, which deepens the knowledge and understanding of applications of statistical methods and analyses of clinical trials. … The many good motivating examples make the book a useful resource for instructors teaching introductory statistics courses. I enjoyed reading this book, and you will too.” (Technometrics, Vol. 52 (2), May, 2010)

Editors and Affiliations

  • Albert Schweitzer Hospital, Dordrecht, The Netherlands

    Ton J. Cleophas

  • Academic Medical Center, Amsterdam, The Netherlands

    Aeilko H. Zwinderman

  • Damen Shipyards, Gorinchem, The Netherlands

    Toine F. Cleophas

  • Technical University, Delft, The Netherlands

    Eugene P. Cleophas

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