Preface, viii. 1 Basic design considerations, 1
2 Distributions and confidence intervals, 14
Table 2.1 The Normal distribution functionaprobability that a
Normally distributed variable is less than z, 27
Table 2.2 Percentage points of the Normal distribution for a and 1
- ß, 28
Table 2.3 Values of ?(a, ß) = (z1-a/2 + z1-ß)2, 28
Table 2.4 The t-distribution, 29
3 Comparing two independent groups for binary data, 30
Table 3.1 Sample size for the comparison of two proportions, 38
Table 3.2 Sample size for the comparison of two proportions using
the odds ratio (OR), 40
4 Comparing two independent groups for ordered categorical data,
42
5 Comparing two independent groups for continuous data, 47
Table 5.1 Sample sizes for the two sample t-test with two-sided a =
0.05, 54
Table 5.2 Sample sizes for the two sample t-test with unequal
variances, 55
Table 5.3 Sample sizes for the one sample t-test with two-sided a =
0.05, 57
6 Cluster designs, repeated measures data and more than two groups,
58
Table 6.1 Multiplying factor for repeated measures designs, 66
7 Comparing paired groups for binary, ordered categorical and
continuous outcomes, 67
Table 7.1 Sample sizes for paired binary data, 80
Table 7.2 Sample sizes for paired continuous data with two-sided a
= 0.05, 81
8 Comparing survival curves, 82
Table 8.1 Number of critical events for comparison of survival
rates (Logrank test), 95
Table 8.2 Number of subjects for comparison of survival rates
(Logrank test), 97
Table 8.3 Number of critical events for comparison of two
exponential survival distributions with two-sided a = 0.05, 99
9 Equivalence, 100
Table 9.1 Sample sizes for bioequivalence studiesadifference
between two means or ratio of two means, 115
Table 9.2 Sample sizes for testing the equivalence of two means,
116
Table 9.3 Sample sizes for testing the equivalence of two
proportions, 118
10 Confidence intervals, 120
Table 10.1 Sample sizes required to observe a given confidence
interval width for a given proportion in a sample from a large
population, 134
Table 10.2 Sample sizes required to observe a given confidence
interval width for the difference between two
proportionsaindependent groups, 135
Table 10.3 Sample sizes required to observe a proportionate
confidence interval width for the difference between two groups
expressed via the odds ratio (OR), 136
Table 10.4 Sample sizes required to observe a given confidence
interval width for the difference between two proportions from
paired or matched groups, 137
Table 10.5 Sample sizes required to observe a given confidence
interval width to estimate a single mean or the difference between
two means for independent or matched groups, 139
11 Post-marketing surveillance, 140
Table 11.1 Sample sizes required to observe a total of a adverse
reactions with a given probability 1 - ß and anticipated incidence
?, 147
Table 11.2 Sample sizes required for detection of a specific
adverse reaction with background incidence, ?0, known, 148
Table 11.3 Sample sizes required for detection of a specific
adverse reaction with background incidence unknown, 149
Table 11.4 Number of cases to be observed in a case-control study,
150
12 The correlation coefficient, 151
Table 12.1 Sample sizes for detecting a statistically significant
correlation coefficient, 155
13 Reference intervals and receiver operating curves, 156
Table 13.1 Sample sizes in order to obtain a required reference
intervalaNormal distribution, 167
Table 13.2 Sample sizes in order to obtain a required reference
intervalanon-Normal distribution, 168
Table 13.3 Sample sizes required to observe a given sensitivity and
specificity in diagnostic accuracy studiesasingle sample, 169
Table 13.4 Sample sizes required to observe a given sensitivity and
specificity in diagnostic accuracy studiesatwo sample unpaired
design, 171
Table 13.5 Sample sizes required to observe a given sensitivity and
specificity in diagnostic accuracy studiesatwo sample matched
paired design, 173
Table 13.6 Sample sizes required to observe a given confidence
interval width for receiver operating curves (ROC), 175
14 Observer agreement studies, 177
Table 14.1 Sample sizes required to observe a given confidence
interval to estimate the proportion of disagreements between two
observers, 187
Table 14.2 Sample sizes required to observe a given confidence
interval to estimate the within observer variation, 188
Table 14.3 Sample sizes required to observe a given confidence
interval to minimise the number of subjects required to achieve the
desired precision in the probability of their disagreement, TDis,
189
Table 14.4 Sample sizes required to observe a given confidence
interval width for inter-observer agreement using Cohen's Kappa?,
190
Table 14.5 Sample sizes required to observe a given intra-class
correlation using confidence interval approach, 191
Table 14.6 Sample sizes required to observe a given intra-class
correlation using hypothesis testing approach with two-sided a =
0.05, 192
15 Dose finding studies, 193
16 Phase II trials, 205
Table 16.1 Fleming?A?Hern single-stage Phase II design, 223
Table 16.2 Gehan two-stage Phase II designaStage 1, 224
Table 16.3 Gehan two-stage Phase II designaStage 2, 225
Table 16.4 Simon Optimal and Minimax designs, 226
Table 16.5 Bayesian single threshold design (STD), 227
Table 16.6 Bayesian dual threshold design (DTD), 228
Table 16.7 Case and Morgan design (EDA) with a = 0.05, 229
Table 16.8 Case and Morgan design (ETSL) with a = 0.05, 230
Table 16.9 Simon, Wittes and Ellenberg design, 231
Table 16.10 Bryant and Day design, 233
17 Sample size software , 235
Cumulative references, 237
Index, 247
David Machin, Children's Cancer and Leukaemia Group, University of Leicester, UK; Division of Clinical Trials and Epidemiological Sciences, National Cancer Centre, Singapore; Medical Statistics Unit, School of Health and Related Sciences, University of Sheffield, UK Michael J. Campbell, Medical Statistics Unit, School of Health and Related Sciences, University of Sheffield, UK Say Beng Tan, Singapore Clinical Research Institute, Singapore; Duke-NUS Graduate Medical School, Singapore Sze Huey Tan, Division of Clinical Trials and Epidemiological Sciences, National Cancer Centre, Singapore
?Sample Size Tables for Clinical Studies, 3rd Edition provides comprehensive, practical and up-to-date information on sample sizes for clinical studies.? (Journal of Clinical Research Best Practices, June 2009)
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