Sample Sizes for Clinical, Laboratory and Epidemiology Studies
You are now holding a toolbox for medical statisticians and clinical investigators who want the statistical tools - equations, formulae and numerical tables - needed to design and plan clinical studies.
1132999021
Sample Sizes for Clinical, Laboratory and Epidemiology Studies
You are now holding a toolbox for medical statisticians and clinical investigators who want the statistical tools - equations, formulae and numerical tables - needed to design and plan clinical studies.
87.0 In Stock
Sample Sizes for Clinical, Laboratory and Epidemiology Studies

Sample Sizes for Clinical, Laboratory and Epidemiology Studies

Sample Sizes for Clinical, Laboratory and Epidemiology Studies

Sample Sizes for Clinical, Laboratory and Epidemiology Studies

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Overview

You are now holding a toolbox for medical statisticians and clinical investigators who want the statistical tools - equations, formulae and numerical tables - needed to design and plan clinical studies.

Product Details

ISBN-13: 9781118874936
Publisher: Wiley
Publication date: 05/29/2018
Sold by: JOHN WILEY & SONS
Format: eBook
Pages: 400
File size: 15 MB
Note: This product may take a few minutes to download.

About the Author

David Machin, Leicester Cancer Research Centre, University of Leicester, Leicester and Medical Statistics Group, School of Health and Related Research, University of Sheffield, Sheffield, UK.

Michael J. Campbell, Medical Statistics Group, School of Health and Related Research, University of Sheffield, Sheffield, UK.

Say Beng Tan, SingHealth Duke-NUS Academic Medical Centre, Singapore.

Sze Huey Tan, Division of Clinical Trials and Epidemiological Sciences, National Cancer Centre, Singapore.

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Table of Contents

Preface viii

1 Basic design considerations 1

2 Distributions and confidence intervals 14

Table 2.1 The Normal distribution function-probability that a Normally distributed variable is less than z 27

Table 2.2 Percentage points of the Normal distribution for [alpha] and 1 - [beta] 28

Table 2.3 Values of [theta]([alpha],[beta]) = (z[subscript 1-alpha/2] + z[subscript 1-beta])[superscript 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 [alpha] = 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 [alpha] = 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 82

Table 7.2 Sample sizes for paired continuous data with two-sided [alpha] = 0.05 83

8 Comparing survival curves 84

Table 8.1 Number of critical events for comparison of survival rates (Logrank test) 97

Table 8.2 Number of subjects for comparison of survival rates (Logrank test) 99

Table 8.3 Number of critical events for comparison of two exponential survival distributions with two-sided [alpha] = 0.05101

9 Equivalence 102

Table 9.1 Sample sizes for bioequivalence studies-difference between two means or ratio of two means 117

Table 9.2 Sample sizes for testing the equivalence of two means 118

Table 9.3 Sample sizes for testing the equivalence of two proportions 120

10 Confidence intervals 122

Table 10.1 Sample sizes required to observe a given confidence interval width for a given proportion in a sample from a large population 136

Table 10.2 Sample sizes required to observe a given confidence interval width for the difference between two proportions-independent groups 137

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) 138

Table 10.4 Sample sizes required to observe a given confidence interval width for the difference between two proportions from paired or matched groups 139

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 141

11 Post-marketing surveillance 142

Table 11.1 Sample sizes required to observe a total of a adverse reactions with a given probability 1 - [belta] and anticipated incidence [lambda] 149

Table 11.2 Sample sizes required for detection of a specific adverse reaction with background incidence, [lambda subscript 0], known 150

Table 11.3 Sample sizes required for detection of a specific adverse reaction with background incidence unknown 151

Table 11.4 Number of cases to be observed in a case-control study 152

12 The correlation coefficient 153

Table 12.1 Sample sizes for detecting a statistically significant correlation coefficient 157

13 Reference intervals and receiver operating curves 158

Table 13.1 Sample sizes in order to obtain a required reference interval-Normal distribution 169

Table 13.2 Sample sizes in order to obtain a required reference interval-non-Normal distribution 170

Table 13.3 Sample sizes required to observe a given sensitivity or specificity in diagnostic accuracy studies-single sample 171

Table 13.4 Sample sizes required to observe a given sensitivity or specificity in diagnostic accuracy studies-two sample unpaired design 173

Table 13.5 Sample sizes required to observe a given sensitivity or specificity in diagnostic accuracy studies-two sample matched paired design 175

Table 13.6 Sample sizes required to observe a given confidence interval width for receiver operating curves (ROC) 177

14 Observer agreement studies 179

Table 14.1 Sample sizes required to observe a given confidence interal to estimate the proportion of disagreements between two observers 189

Table 14.2 Sample sizes required to observe a given confidence interval to estimate the within observer variation 190

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, [curly or open theta subscript Dis] 191

Table 14.4 Sample sizes required to observe a given confidence interval width for inter-observer agreement using Cohen's Kappa, [kappa] 192

Table 14.5 Sample sizes required to observe a given intra-class correlation, [rho], using the confidence interval approach 193

Table 14.6 Sample sizes required to observe a given intra-class correlation using the hypothesis testing approach with two-sided [alpha] = 0.05 194

15 Dose finding studies 195

16 Phase II trials 207

Table 16.1 Fleming-A'Hern single-stage Phase II design 225

Table 16.2 Gehan two-stage Phase II design-Stage 1 226

Table 16.3 Gehan two-stage Phase II design-Stage 2 227

Table 16.4 Simon Optimal and Minimax designs 228

Table 16.5 Bayesian single threshold design (STD) 229

Table 16.6 Bayesian dual threshold design (DTD) 230

Table 16.7 Case and Morgan EDA design with [alpha] = 0.05 231

Table 16.8 Case and Morgan ETSL design with [alpha] = 0.05 232

Table 16.9 Simon, Wittes and Ellenberg design 233

Table 16.10 Bryant and Day design 235

17 Sample size software [characters not reproducible] 237

Cumulative references 239

Author index 249

Subject index 253

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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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