Description
Taylor & Francis Ltd Sample Sizes For Clinical Trials 2009 Edition by Steven A. Julious
Drawing on various real-world applications, Sample Sizes for Clinical Trials takes readers through the process of calculating sample sizes for many types of clinical trials. It provides descriptions of the calculations with a practical emphasis.Focusing on normal, binary, ordinal, and survival data, the book explores a range of trials, including superiority, equivalence, non-inferiority, bioequivalence, and precision for both parallel group and crossover designs. The author discusses how trial objectives impact the study design with respect to the derivation of formulae for sample size calculations. He uses real-life studies throughout to show how the concepts and calculations can be employed.This work underscores the importance of sample size calculation in the design of a clinical trial. With useful calculation tables throughout, it enables readers to quickly find an appropriate formula, formula application, and associated worked example.Watch the author speak about this book at JSM 2012 in San Diego. IntroductionBackground to Randomized Controlled TrialsTypes of Clinical TrialAssessing Evidence from TrialsSuperiority TrialsEquivalence TrialsNon-Inferiority TrialsAs-Good-as-or-Better TrialsAssessment of BioequivalenceEstimation to a Given PrecisionSeven Key Steps to Cook up a Sample SizeIntroductionStep 1: Deciding on the Trial ObjectiveStep 2: Deciding on the EndpointStep 3: Determining the Effect Size (or Margin)Step 4: Assessing the Population VariabilityStep 5: Type I ErrorStep 6: Type II ErrorStep 7: Other FactorsSample Sizes for Parallel Group Superiority Trials with Normal DataIntroductionSample Sizes Estimated Assuming the Population Variance to Be KnownDesign ConsiderationsRevisiting Worked Example Sensitivity AnalysisCalculations Taking Account of the Imprecision of the Variance Used in the Sample Size CalculationsInterim Analyses and Sample Size Re-EstimationCluster Randomized TrialsSample Size Calculations for Superiority Crossover Trials with Normal DataIntroductionSample Sizes Estimated Assuming the Population Variance to Be KnownSensitivity Analysis about the Variance Used in theSample Size CalculationsCalculations Taking Account of the Imprecision of the Variance Used in the Sample Size CalculationsSample Size Calculations for Equivalence Clinical Trials with Normal DataIntroductionParallel Group TrialsCrossover TrialsSample Size Calculations for Non-Inferiority Clinical Trials with Normal DataIntroductionParallel Group TrialsCrossover TrialsAs-Good-as-or-Better TrialsSample Size Calculations for Bioequivalence TrialsIntroductionCrossover TrialsParallel Group StudiesSample Size Calculations for Precision-Based Clinical Trials with Normal DataIntroductionParallel Group TrialsCrossover TrialsSample Size Calculations for Parallel Group Superiority Clinical Trials with Binary DataIntroductionInference and Analysis of Clinical Trials with Binary DataSample Sizes with the Population Effects Assumed KnownInclusion of Baselines or CovariatesSample Size Re-EstimationSensitivity Analysis about the Estimates of the Population Effects Used in the Sample Size CalculationsCalculations Taking Account of the Imprecision of the Estimates of the Population Effects Used in the Sample Size CalculationsCalculations Taking Account of the Imprecision of the Estimates Used in the Sample Size Calculations: Bayesian MethodsSample Size Calculations for Superiority Crossover Clinical Trials with Binary DataIntroductionAnalysis of a TrialAnalysis of a Trial RevisitedSensitivity Analysis about the Estimates of the Population Effects Used in the Sample Size CalculationsCalculations Taking Account of the Imprecision of the Estimates of the Population Effects Used in the Sample Size CalculationsCalculations Taking Account of the Imprecision of the Estimates Used in the Sample Size Calculations: Bayesian MethodsSample Size Calculations for Non-Inferiority Trials with Binary DataIntroductionChoice of Non-Inferiority LimitParallel Group Trials Sample Size with the Population Effects Assumed KnownAs-Good-as-or-Better TrialsSample Size Calculations for Equivalence Trials with Binary DataIntroductionParallel Group TrialsCrossover TrialsSample Size Calculations for Precision-Based Trials with Binary DataIntroductionParallel Group TrialsCrossover TrialsSample Size Calculations for Clinical Trials with Ordinal DataIntroductionThe Quality-of-Life DataSuperiority TrialsNon-Inferiority TrialsAs-Good-as-or-Better TrialsEquivalence TrialsEstimation to a Given PrecisionSample Size Calculations for Clinical Trials with Survival DataIntroductionSuperiority TrialsNon-Inferiority TrialsEquivalence TrialsPrecision-Based TrialsReferencesAppendix