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Sample Size Tables for Clinical Studies

De
264 pages
This book provides statisticians and researchers with the statistical tools - equations, formulae and numerical tables - to design and plan clinical studies and carry out accurate, reliable and reproducible analysis of the data so obtained. There is no way around this as incorrect procedure in clinical studies means that the researcher's paper will not be accepted by a peer-reviewed journal. Planning and analysing clinical studies is a very complicated business and this book provides indispensible factual information.

Please go to http://booksupport.wiley.com and enter 9781405146500 to easily download the supporting materials.
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Contents
Preface, viii
1 Basic design considerations, 1
2 Distributions and confidence intervals, 14 Table 2.1The Normal distribution functionaprobability that a Normally distributed variable is less thanz, 27 Table 2.2Percentage points of the Normal distribution forαand 1β, 28 2 Table 2.3Values ofθ(α,β)=(z+z) , 28 1α/2 1β Table 2.4Thet-distribution, 29
3 Comparing two independent groups for binary data, 30 Table 3.1Sample size for the comparison of two proportions, 38 Table 3.2Sample 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 5.1Sample sizes for the two samplet-test with two-sidedα=0.05, 54 Table 5.2Sample sizes for the two samplet-test with unequal variances, 55 Table 5.3Sample sizes for the one samplet-test with two-sidedα=0.05, 57
6 Cluster designs, repeated measures data and more than two groups, 58 Table 6.1Multiplying factor for repeated measures designs, 66
7 Comparing paired groups for binary, ordered categorical and continuous outcomes, 67 Table 7.1Sample sizes for paired binary data, 82 Table 7.2Sample sizes for paired continuous data with two-sidedα=0.05, 83
8 Comparing survival curves, 84 Table 8.1Number of critical events for comparison of survival rates (Logrank test), 97 Table 8.2Number of subjects for comparison of survival rates (Logrank test), 99 Table 8.3Number of critical events for comparison of two exponential survival distributions with two-sidedα=0.05, 101
v
vi
Contents
9 Equivalence, 102 Table 9.1Sample sizes for bioequivalence studiesadifference between two means or ratio of two means, 117 Table 9.2Sample sizes for testing the equivalence of two means, 118 Table 9.3Sample sizes for testing the equivalence of two proportions, 120
10 Confidence intervals, 122 Table 10.1Sample sizes required to observe a given confidence interval width for a given proportion in a sample from a large population, 136 Table 10.2Sample sizes required to observe a given confidence interval width for the difference between two proportionsaindependent groups, 137 Table 10.3Sample sizes required to observe a proportionate confidence interval width for the difference between two groups expressed via the odds ratio (OR), 138 Table 10.4Sample sizes required to observe a given confidence interval width for the difference between two proportions from paired or matched groups, 139 Table 10.5Sample 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, 141
11 Post-marketing surveillance, 142 Table 11.1Sample sizes required to observe a total ofaadverse reactions with a given probability 1βand anticipated incidenceλ, 149 Table 11.2Sample sizes required for detection of a specific adverse reaction with background incidence,λ, known, 150 0 Table 11.3Sample sizes required for detection of a specific adverse reaction with background incidence unknown, 151 Table 11.4Number of cases to be observed in a case-control study, 152
12 The correlation coefficient, 153 Table 12.1Sample sizes for detecting a statistically significant correlation coefficient, 157
13 Reference intervals and receiver operating curves, 158 Table 13.1Sample sizes in order to obtain a required reference intervalaNormal distribution, 169 Table 13.2Sample sizes in order to obtain a required reference intervalanon-Normal distribution, 170 Table 13.3Sample sizes required to observe a given sensitivity or specificity in diagnostic accuracy studiesasingle sample, 171 Table 13.4Sample sizes required to observe a given sensitivity or specificity in diagnostic accuracy studiesatwo sample unpaired design, 173 Table 13.5Sample sizes required to observe a given sensitivity or specificity in diagnostic accuracy studiesatwo sample matched paired design, 175 Table 13.6Sample sizes required to observe a given confidence interval width for receiver operating curves (ROC), 177
Contents
vii
14 Observer agreement studies, 179 Table 14.1Sample sizes required to observe a given confidence interval to estimate the proportion of disagreements between two observers, 189 Table 14.2Sample sizes required to observe a given confidence interval to estimate the within observer variation, 190 Table 14.3Sample 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,Θ, 191 Dis Table 14.4Sample sizes required to observe a given confidence interval width for inter-observer agreement using Cohen’s Kappa,κ, 192 Table 14.5Sample sizes required to observe a given intra-class correlation,ρ , using the confidence interval approach, 193 Table 14.6Sample sizes required to observe a given intra-class correlation using the hypothesis testing approach with two-sidedα=0.05, 194
15 Dose finding studies, 195
16 Phase II trials, 207 Table 16.1Fleming–A’Hern single-stage Phase II design, 225 Table 16.2Gehan two-stage Phase II designaStage 1, 226 Table 16.3Gehan two-stage Phase II designaStage 2, 227 Table 16.4Simon Optimal and Minimax designs, 228 Table 16.5Bayesian single threshold design (STD), 229 Table 16.6Bayesian dual threshold design (DTD), 230 Table 16.7Case and Morgan EDA design withα=0.05, 231 Table 16.8Case and Morgan ETSL design withα=0.05, 232 Table 16.9Simon, Wittes and Ellenberg design, 233 Table 16.10Bryant and Day design, 235
S 17 Sample size software , 237 SS
Cumulative references, 239 Author index, 249 Subject index, 253
S SS A companion CD-ROM of the sample size software of this book
is included in the inside back cover