Statistics Applied to Clinical Studies [electronic resource] /
Cleophas, Ton J.author.
Zwinderman, Aeilko H.author.
Thanks to the omnipresent computer, current statistics can include data files of many thousands of values, and can perform any exploratory analysis in less than seconds. This development, however fascinating, generally does not lead to simple results. We should not forget that clinical studies are, mostly, for confirming prior hypotheses based on sound arguments, and the simplest tests provide the best power and are adequate for such studies. In the past few years the authors of this 5th edition, as teachers and research supervisors in academic and top-clinical facilities, have been able to closely observe the latest developments in the field of clinical data analysis, and they have been able to assess their performance. In this 5th edition the 47 chapters of the previous edition have been maintained and upgraded according to the current state of the art, and 20 novel chapters have been added after strict selection of the most valuable and promising novel methods. The novel methods are explained using practical examples and step-by-step analyses readily accessible for non-mathematicians. All of the novel chapters have been internationally published by the authors in peer-reviewed journal, including the American Journal of Therapeutics, the European Journal of Clinical Investigation, The International journal of Clinical Pharmacology and therapeutics, and other journals, and permission is granted by all of them to use this material in the current book. We should add that the authors are well-qualified in their fields of knowledge. Professor Zwinderman is president-elect of the International Society of Biostatistics, and Professor Cleophas is past-president of the American College of Angiology. From their expertise they should be able to make adequate selections of modern methods for clinical data analysis for the benefit of physicians, students, and investigators. The authors, although from a different discipline, one clinician and one statistician, have been working and publishing together for over 10 years, and their research of statistical methodology can be characterized as a continued effort to demonstrate that statistics is not mathematics but rather a discipline at the interface of biology and mathematics. They firmly believe that any reader can benefit from this clinical approach to statistical data analysis.
Description based upon print version of record.
""Statistics Applied to Clinical Studies""; ""Foreword""; ""Preface to First Edition""; ""Preface to Second Edition""; ""Preface to the Third Edition""; ""Preface to Fourth Edition""; ""Preface to Fifth Edition""; ""Contents""; ""Chapter 1: Hypotheses, Data, Stratification""; ""1 General Considerations""; ""2 Two Main Hypotheses in Drug Trials: Efficacy and Safety""; ""3 Different Types of Data: Continuous Data""; ""4 Different Types of Data: Proportions, Percentages and Contingency Tables""; ""5 Different Types of Data: Correlation Coefficient""; ""6 Stratification Issues""
""7 Randomized Versus Historical Controls""""8 Factorial Designs""; ""9 Conclusions""; ""References""; ""Chapter 2: The Analysis of Efficacy Data""; ""1 Overview""; ""2 The Principle of Testing Statistical Significance""; ""3 The t-Value = Standardized Mean Result of Study""; ""4 Unpaired t-Test""; ""5 Null-Hypothesis Testing of Three or More Unpaired Samples""; ""6 Three Methods to Test Statistically a Paired Sample""; ""6.1 First Method""; ""6.2 Second Method""; ""6.3 Third Method""; ""7 Null-Hypothesis Testing of Three or More Paired Samples""
""8 Null-Hypothesis Testing with Complex Data""""9 Paired Data with a Negative Correlation""; ""9.1 Studies Testing Significance of Differences""; ""9.2 Studies Testing Equivalence""; ""10 Rank Testing""; ""10.1 Paired Test: Wilcoxon Signed Rank Test""; ""10.2 Unpaired Test: Mann-Whitney Test""; ""11 Rank Testing for Three or More Samples""; ""11.1 The Friedman Test for Paired Observations""; ""11.2 The Kruskall-Wallis Test for Unpaired Observations""; ""12 Conclusions""; ""References""; ""Chapter 3: The Analysis of Safety Data""; ""1 Introduction , Summary Display""
""2 Four Methods to Analyze Two Unpaired Proportions""""2.1 Method 1""; ""2.2 Method 2""; ""2.3 Method 3""; ""2.4 Method 4""; ""3 Chi-square to Analyze More Than Two Unpaired Proportions""; ""4 McNemarâ€?s Test for Paired Proportions""; ""5 Multiple Paired Binary Data (Cochranâ€?s Q Test)""; ""6 Survival Analysis""; ""6.1 Survival Analysis""; ""6.2 Testing Significance of Difference Between Two Kaplan-Meier Curves""; ""7 Odds Ratio Method for Analyzing Two Unpaired Proportions""; ""8 Odds Ratios for One Group, Two Treatments""; ""9 Conclusions""
""Chapter 4: Log Likelihood Ratio Tests for Safety Data Analysis""""1 Introduction""; ""2 Numerical Problems with Calculating Exact Likelihoods""; ""3 The Normal Approximation and the Analysis of Clinical Events""; ""4 Log Likelihood Ratio Tests and the Quadratic Approximation""; ""5 More Examples""; ""6 Discussion""; ""7 Conclusions""; ""References""; ""Chapter 5: Equivalence Testing""; ""1 Introduction""; ""2 Overview of Possibilities with Equivalence Testing""; ""3 Calculations""; ""4 Equivalence Testing, a New Gold Standard?""; ""5 Validity of Equivalence Trials""
""6 Special Point: Level of Correlation in Paired Equivalence Studies""
Includes bibliographical references and index.
Thanks to the omnipresent computer, current statistics can include data files of many thousands of values, and can perform any exploratory analysis in less than seconds. This development, however fascinating, generally does not lead to simple results. We should not forget that clinical studies are, mostly, for confirming prior hypotheses based on sound arguments, and the simplest tests provide the best power and are adequate for such studies. In the past few years the authors of this 5th edition, as teachers and research supervisors in academic and top-clinical facilities, have been able to closely observe the latest developments in the field of clinical data analysis, and they have been able to assess their performance. In this 5th edition the 47 chapters of the previous edition have been maintained and upgraded according to the current state of the art, and 20 novel chapters have been added after strict selection of the most valuable and promising novel methods. The novel methods are explained using practical examples and step-by-step analyses readily accessible for non-mathematicians. All of the novel chapters have been internationally published by the authors in peer-reviewed journal, including the American Journal of Therapeutics, the European Journal of Clinical Investigation, The International journal of Clinical Pharmacology and therapeutics, and other journals, and permission is granted by all of them to use this material in the current book. We should add that the authors are well-qualified in their fields of knowledge. Professor Zwinderman is president-elect of the International Society of Biostatistics, and Professor Cleophas is past-president of the American College of Angiology. From their expertise they should be able to make adequate selections of modern methods for clinical data analysis for the benefit of physicians, students, and investigators. The authors, although from a different discipline, one clinician and one statistician, have been working and publishing together for over 10 years, and their research of statistical methodology can be characterized as a continued effort to demonstrate that statistics is not mathematics but rather a discipline at the interface of biology and mathematics. They firmly believe that any reader can benefit from this clinical approach to statistical data analysis.
Medicine.
Laboratory medicine.
Statistics.
Internal medicine.
Biomedicine, general.
Laboratory Medicine.
Statistics, general.
Statistics for Life Sciences, Medicine, Health Sciences.
Internal Medicine.