Sample Size Calculations in Clinical ResearchSample size calculation plays an important role in clinical research. It is not uncommon, however, to observe discrepancies among study objectives (or hypotheses), study design, statistical analysis (or test statistic), and sample size calculation. Focusing on sample size calculation for studies conducted during the various phases of clinical resea |
Contents
Introduction | 1 |
11 Regulatory Requirement | 2 |
12 Basic Considerations | 7 |
13 Procedures for Sample Size Calculation | 14 |
14 Aims and Structure of the Book | 21 |
Considerations Prior to Sample Size Calculation | 25 |
21 Confounding and Interaction | 26 |
22 OneSided Test Versus TwoSided Test | 28 |
71 Basic Concepts | 161 |
72 Exponential Model | 163 |
73 Coxs Proportional Hazards Model | 171 |
74 Weighted LogRank Test | 176 |
75 Practical Issues | 182 |
Group Sequential Methods | 184 |
81 Pococks Test | 185 |
82 OBrien and Flemings Test | 189 |
23 Crossover Design Versus Parallel Design | 30 |
24 SubgroupInterim Analyses | 32 |
25 Data Transformation | 36 |
26 Practical Issues | 38 |
Comparing Means | 47 |
31 OneSample Design | 48 |
32 TwoSample Parallel Design | 55 |
33 TwoSample Crossover Design | 63 |
34 MultipleSample OneWay ANOVA | 68 |
35 MultipleSample Williams Design | 72 |
36 Practical Issues | 76 |
Large Sample Tests for Proportions | 81 |
41 OneSample Design | 82 |
42 TwoSample Parallel Design | 87 |
43 TwoSample Crossover Design | 93 |
44 OneWay Analysis of Variance | 97 |
45 Williams Design | 99 |
46 Relative RiskParallel Design | 102 |
47 Relative RiskCrossover Design | 107 |
48 Practical Issues | 109 |
Exact Tests for Proportions | 115 |
52 Fishers Exact Test | 118 |
53 Optimal MultipleStage Designs for Single Arm Trials | 121 |
54 Flexible Designs for MultipleArm Trials | 138 |
55 Remarks | 140 |
Tests for GoodnessofFit and Contingency Tables | 142 |
61 Tests for GoodnessofFit | 143 |
62 Test for IndependenceSingle Stratum | 145 |
63 Test for IndependenceMultiple Strata | 148 |
64 Test for Categorical Shift | 150 |
65 CarryOver Effect Test | 155 |
66 Practical Issues | 158 |
Comparing TimetoEvent Data | 160 |
83 Wang and Tsiatis Test | 190 |
84 Inner Wedge Test | 194 |
85 Binary Variables | 198 |
86 TimetoEvent Data | 199 |
87 Alpha Spending Function | 201 |
88 Sample Size ReEstimation | 203 |
89 Conditional Power | 206 |
810 Practical Issues | 208 |
91 Comparing IntraSubject Variabilities | 213 |
92 Comparing IntraSubject CVs | 221 |
93 Comparing InterSubject Variabilities | 230 |
94 Comparing Total Variabilities | 238 |
95 Practical Issues | 251 |
101 Bioequivalence Criteria | 255 |
102 Average Bioequivalence | 256 |
103 Population Bioequivalence | 260 |
104 Individual Bioequivalence | 262 |
105 In Vitro Bioequivalence | 268 |
111 Violation of Assumptions | 277 |
112 OneSample Location Problem | 278 |
113 TwoSample Location Problem | 282 |
114 Test for Independence | 286 |
115 Practical Issues | 289 |
Sample Size Calculation in Other Areas | 292 |
121 Dose Response Studies | 293 |
122 ANOVA with Repeated Measures | 301 |
123 Quality of Life | 307 |
124 Bridging Studies | 310 |
125 Vaccine Clinical Trials | 320 |
References | 338 |
| 354 | |
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Sample Size Calculations in Clinical Research Shein-Chung Chow,Hansheng Wang,Jun Shao Limited preview - 2003 |
Common terms and phrases
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