Clinical Trials

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❘❙❚■ ContentsContentsIntroductionxiiPart I: Fundamentals of Trial DesignChapter 1 Randomized Clinical Trials 1Chapter 2 Uncontrolled Trials 15Chapter 3 Protocol Development 23Chapter 4 Endpoints 37Chapter 5 Patient Selection 47Chapter 6 Source and Control of Bias 55Chapter 7 Randomization 65Chapter 8 Blinding 75Chapter 9 Sample Size and Power 81Part II: Alternative Trial DesignsChapter 10 Crossover Trials 91Chapter 11 Factorial Design 101Chapter 12 Equivalence Trials 113Chapter 13 Bioequivalence Trials 119Chapter 14 Noninferiority Trials 131Chapter 15 Cluster Randomized Trials 141Chapter 16 Multicenter Trials 153Part III: Basics of Statistical AnalysisChapter 17 Types of Data and Normal Distribution 167Chapter 18 Significance Tests and Confidence Intervals 185Chapter 19 Comparison of Means 197Chapter 20 Comparison of Proportions 217Chapter 21 Analysis of Survival Data 235
Clinical Trials: A Practical Guide ■❚❙❘Part IV: Special Trial Issues in Data AnalysisChapter 22 Intention-to-Treat Analysis 255Chapter 23 Subgroup Analysis 265Chapter 24 Regression Analysis 273Chapter 25 Adjustment for Covariates 287Chapter 26 Confounding 295Chapter 27 Interaction 305Chapter 28 Repeated Measurements 317Chapter 29 Multiplicity 329Chapter 30 Missing Data 339Chapter 31 Interim Monitoring and Stopping Rules 353Part V: Reporting of TrialsChapter 32 Overview of Reporting 365Chapter 33 Trial Profile 377Chapter 34 Presenting Baseline Data 385Chapter 35 Use of Tables 391Chapter 36 Use of Figures 407Chapter 37 Critical Appraisal of a Report 427Chapter 38 Meta-Analysis 439Glossary 453Abbreviations 461Index 467xi
Page 8: ❘❙❚■ ContributorsStephen L
Page 11: Clinical Trials: A Practical Guide
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Clinical Trials: A Practical Guide
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■■❚❙❘Part IIIBasics ofSta
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■■❚❙❘Chapter 19Comparison
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■■❚❙❘Chapter 20Comparison
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■■❚❙❘Part IVSpecial Trial
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■■❚❙❘Chapter 24Regression
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■■❚❙❘Chapter 25Adjustment
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■■❚❙❘Chapter 32Overview o
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■■❚❙❘GlossaryGlossary453
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■■❚❙❘IndexIndex467
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Clinical Trials

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