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9781444300727

Sample Size Tables for Clinical Studies, 3rd Edition

by ; ; ;
  • ISBN13:

    9781444300727

  • ISBN10:

    1444300725

  • Format: eBook
  • Copyright: 2009-01-01
  • Publisher: BMJ Books
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Summary

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.

Table of Contents

Prefacep. viii
Basic design considerationsp. 1
Distributions and confidence intervalsp. 14
The Normal distribution functionaprobability that a Normally distributed variable is less than zp. 27
Percentage points of the Normal distribution for ? and 1 − ?p. 28
Values of ?(?, ?) = (z1−?/2 + z1−?)2p. 28
The t-distributionp. 29
Comparing two independent groups for binary datap. 30
Sample size for the comparison of two proportionsp. 38
Sample size for the comparison of two proportions using the odds ratio (OR)p. 40
Comparing two independent groups for ordered categorical datap. 42
Comparing two independent groups for continuous datap. 47
Sample sizes for the two sample t-test with two-sided ? = 0.05p. 54
Sample sizes for the two sample t-test with unequal variancesp. 55
Sample sizes for the one sample t-test with two-sided ? = 0.05p. 57
Cluster designs, repeated measures data and more than two groupsp. 58
Multiplying factor for repeated measures designsp. 66
Comparing paired groups for binary, ordered categorical and continuous outcomesp. 67
Sample sizes for paired binary datap. 80
Sample sizes for paired continuous data with two-sided ? = 0.05p. 81
Comparing survival curvesp. 82
Number of critical events for comparison of survival rates (Logrank test)p. 95
Number of subjects for comparison of survival rates (Logrank test)p. 97
Number of critical events for comparison of two exponential survival distributions with two-sided ? = 0.05p. 99
Equivalencep. 100
Sample sizes for bioequivalence studiesadifference between two means or ratio of two meansp. 115
Sample sizes for testing the equivalence of two meansp. 116
Sample sizes for testing the equivalence of two proportionsp. 118
Confidence intervalsp. 120
Sample sizes required to observe a given confidence interval width for a given proportion in a sample from a large populationp. 134
Sample sizes required to observe a given confidence interval width for the difference between two proportionsaindependent groupsp. 135
Sample sizes required to observe a proportionate confidence interval width for the difference between two groups expressed via the odds ratio (OR)p. 136
Sample sizes required to observe a given confidence interval width for the difference between two proportions from paired or matched groupsp. 137
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 groupsp. 139
Post-marketing surveillancep. 140
Sample sizes required to observe a total of a adverse reactions with a given probability 1 − ? and anticipated incidence ?p. 147
Sample sizes required for detection of a specific adverse reaction with background incidence, ?0, knownp. 148
Sample sizes required for detection of a specific adverse reaction with tbackground incidence unknownp. 149
Number of cases to be observed in a case-control studyp. 150
The correlation coefficientp. 151
Sample sizes for detecting a statistically significant correlation coefficientp. 155
Reference intervals and receiver operating curvesp. 156
Sample sizes in order to obtain a required reference intervalaNormal distributionp. 167
Sample sizes in order to obtain a required reference intervalanon-Normal distributionp. 168
Sample sizes required to observe a given sensitivity and specificity in diagnostic accuracy studiesasingle samplep. 169
Sample sizes required to observe a given sensitivity and specificity in diagnostic accuracy studiesatwo sample unpaired designp. 171
Sample sizes required to observe a given sensitivity and specificity in diagnostic accuracy studiesatwo sample matched paired designp. 173
Sample sizes required to observe a given confidence interval width for receiver operating curves (ROC)p. 175
Observer agreement studiesp. 177
Sample sizes required to observe a given confidence interval to estimate the proportion of disagreements between two observersp. 187
Sample sizes required to observe a given confidence interval to estimate the within observer variationp. 188
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, ¿Disp. 189
Sample sizes required to observe a given confidence interval width for inter-observer agreement using Cohen's Kappa, ¿p. 190
Sample sizes required to observe a given intra-class correlation using confidence interval approachp. 191
Sample sizes required to observe a given intra-class correlation using hypothesis testing approach with two-sided ? = 0.05p. 192
Dose finding studiesp. 193
Phase II trialsp. 205
Table 16.1p. 223
Table 16.2p. 224
Table 16.3p. 225
Table 16.4p. 226
Table 16.5p. 227
Table 16.6p. 228
Table 16.7p. 229
Table 16.8p. 230
Table 16.9p. 231
Table 16.10p. 233
Sample size softwarep. 235
Cumulative referencesp. 237
Indexp. 247
Table of Contents provided by Publisher. All Rights Reserved.

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