Stella & Rose's Books

Contents

• 1 Introduction
• 1.1 Regulatory Requirement
• 1.2 Basic Considerations
• 1.3 Procedures for Sample Size Calculation
• 1.4 Aims and Structure of the Book
• 2 Considerations Prior to Sample Size Calculation
• 2.1 Confounding and Interaction
• 2.2 One-Sided Test Versus Two-Sided Test
• 2.3 Crossover Design Versus Parallel Design
• 2.4 Subgroup/Interim Analyses
• 2.5 Data Transformation
• 2.6 Practical Issues
• 3 Comparing Means
• 3.1 One Sample Design
• 3.2 Two Sample Parallel Design
• 3.3 Two Sample Crossover Design
• 3.4 Multiple Sample One Way ANOVA
• 3.5 Multiple Sample Williams Design
• 3.6 Practical Issues
• 4 Large Sample Tests for Proportions
• 4.1 One Sample Design
• 4.2 Two Sample Parallel Design
• 4.3 Two Sample Crossover Design
• 4.4 One Way Analysis of Variance
• 4.5 Williams Design
• 4.6 Relative Risk - Parallel Design
• 4.7 Relative Risk - Crossover Design
• 4.8 Practical Issues
• 5 Exact Tests for Proportions
• 5.1 Binomial Test
• 5.2 Fisher's Exact Test
• 5.3 Optimal Multiple-Stage Designs for Single Arm Trials
• 5.4 Flexible Designs for Multiple-Arm Trails
• 5.5 Remarks
• 6 Tests for Goodness-of-Fit and Contingency Tables
• 6.1 Tests for Goodness-of-Fit
• 6.2 Test for Independence - Single Stratum
• 6.3 Test for Independence - Multiple Strata
• 6.4 Test for Categorical Shift
• 6.5 Carry-Over Effect Test
• 6.6 Practical Issues
• 7 Comparing Time-To-Event Data
• 7.1 Basic Concepts
• 7.2 Exponential Model
• 7.3 Cox's Proportional Hazards Model
• 7.4 Weighted Log-Rank Test
• 7.5 Practical Issues
• 8 Group Sequential Methods
• 8.1 Pocock's Test
• 8.2 O'Brien and Fleming's Test
• 8.3 Wang and Tsiatis' Test
• 8.4 Inner Wedge Test
• 8.5 Binary Variables
• 8.6 Time-to-Event Data
• 8.7 Alpha Spending Function
• 8.8 Sample Size Re-estimation
• 8.9 Conditional Power
• 8.10 Practical Issues
• 9 Comparing Variabilities
• 9.1 Comparing Intra-Subject Variabilities
• 9.2 Comparing Intra-Subject CVs
• 9.3 Comparing Intra-Subject Variabilities
• 9.4 Comparing Total Variabilities
• 9.5 Practical Issues
• 10 Bioequivalence Testing
• 10.1 Bioequivalence Criteria
• 10.2 Average Bioequivalence
• 10.3 Population Bioequivalence
• 10.4 Individual Bioequivalence
• 10.5 In Vitro Bioequivalence
• 11 Dose Response Studies
• 11.1 Continuous Response
• 11.2 Binary Response
• 11.3 Time-To-Event Endpoint
• 11.4 Williams' Test for Minimum Effective Dose (MED)
• 11.5 Cochran-Armitage's Test for Trend
• 11.6 Dose Escalation Trials
• 11.7 Concluding Remarks
• 12 Microarray Studies
• 12.1 Literature Review
• 12.2 False Discovery Rate (FDR) Control
• 12.3 Family-Wise Error Rate (FWER) Control
• 12.4 Concluding Remarks
• 13 Bayesian Sample Size Calculation
• 13.1 Posterior Credible Interval Approach
• 13.2 Posterior Error Approach
• 13.3 The Bootstrap-Median Approach
• 13.4 Concluding Remarks
• 14 Nonparametrics
• 14.1 Violation of Assumptions
• 14.2 One-Sample Location Problem
• 14.3 Two-Sample Location Problem
• 14.4 Test for Independence
• 14.5 Practical Issues
• 15 Sample Size Calculation in Other Areas
• 15.1 QT/QTs Studies with Time Dependent Replicates
• 15.2 Propensity Analysis in Non-Randomised Studies
• 15.3 ANOVA with Repeated Measures
• 15.4 Quality of Life
• 15.5 Bridging Studies
• 15.6 Vaccine Clinical Trials
• Appendix
• Bibliography
• Index