Sample Size Tables for Clinical Studies 3rd Edition by David Machin, Michael Campbell, Say Beng Tan, Sze Huey Tan 1405146508 9781405146500

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ISBN 10: 1405146508 

ISBN 13: 9781405146500

Author: David Machin, Michael J. Campbell, Say Beng Tan, Sze Huey Tan

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:

1 Basic design considerations
2 Distributions and confidence intervals
Table 2.1 The Normal distribution function—probability that a Normally distributed variable is less than z
Table 2.2 Percentage points of the Normal distribution for α and 1 – ß
Table 2.3 Values of ?(α, ß) = (z₁-α/2 + z₁-ß)²
Table 2.4 The t-distribution

3 Comparing two independent groups for binary data
Table 3.1 Sample size for the comparison of two proportions
Table 3.2 Sample size for the comparison of two proportions using the odds ratio (OR)

4 Comparing two independent groups for ordered categorical data

5 Comparing two independent groups for continuous data
Table 5.1 Sample sizes for the two sample t-test with two-sided α = 0.05
Table 5.2 Sample sizes for the two sample t-test with unequal variances
Table 5.3 Sample sizes for the one sample t-test with two-sided α = 0.05

6 Cluster designs, repeated measures data and more than two groups
Table 6.1 Multiplying factor for repeated measures designs

7 Comparing paired groups for binary, ordered categorical and continuous outcomes
Table 7.1 Sample sizes for paired binary data
Table 7.2 Sample sizes for paired continuous data with two-sided α = 0.05

8 Comparing survival curves
Table 8.1 Number of critical events for comparison of survival rates (Logrank test)
Table 8.2 Number of subjects for comparison of survival rates (Logrank test)
Table 8.3 Number of critical events for comparison of two exponential survival distributions with two-sided α = 0.05

9 Equivalence
Table 9.1 Sample sizes for bioequivalence studies—difference between two means or ratio of two means
Table 9.2 Sample sizes for testing the equivalence of two means
Table 9.3 Sample sizes for testing the equivalence of two proportions

10 Confidence intervals
Table 10.1 Sample sizes required to observe a given confidence interval width for a given proportion in a sample from a large population
Table 10.2 Sample sizes required to observe a given confidence interval width for the difference between two proportions—independent groups
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)
Table 10.4 Sample sizes required to observe a given confidence interval width for the difference between two proportions from paired or matched groups
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

11 Post-marketing surveillance
Table 11.1 Sample sizes required to observe a total of a adverse reactions with a given probability 1 – ß and anticipated incidence ?
Table 11.2 Sample sizes required for detection of a specific adverse reaction with background incidence, ?₀, known
Table 11.3 Sample sizes required for detection of a specific adverse reaction with background incidence unknown
Table 11.4 Number of cases to be observed in a case-control study

12 The correlation coefficient
Table 12.1 Sample sizes for detecting a statistically significant correlation coefficient

13 Reference intervals and receiver operating curves
Table 13.1 Sample sizes in order to obtain a required reference interval—Normal distribution
Table 13.2 Sample sizes in order to obtain a required reference interval—non-Normal distribution
Table 13.3 Sample sizes required to observe a given sensitivity and specificity in diagnostic accuracy studies—single sample
Table 13.4 Sample sizes required to observe a given sensitivity and specificity in diagnostic accuracy studies—two sample unpaired design
Table 13.5 Sample sizes required to observe a given sensitivity and specificity in diagnostic accuracy studies—two sample matched paired design
Table 13.6 Sample sizes required to observe a given confidence interval width for receiver operating curves (ROC)

14 Observer agreement studies
Table 14.1 Sample sizes required to observe a given confidence interval to estimate the proportion of disagreements between two observers
Table 14.2 Sample sizes required to observe a given confidence interval to estimate the within observer variation
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
Table 14.4 Sample sizes required to observe a given confidence interval width for inter-observer agreement using Cohen’s Kappa
Table 14.5 Sample sizes required to observe a given intra-class correlation using confidence interval approach
Table 14.6 Sample sizes required to observe a given intra-class correlation using hypothesis testing approach with two-sided α = 0.05

15 Dose finding studies

16 Phase II trials
Table 16.1 Fleming–A’Hern single-stage Phase II design
Table 16.2 Gehan two-stage Phase II design—Stage 1
Table 16.3 Gehan two-stage Phase II design—Stage 2
Table 16.4 Simon Optimal and Minimax designs
Table 16.5 Bayesian single threshold design (STD)
Table 16.6 Bayesian dual threshold design (DTD)
Table 16.7 Case and Morgan design (EDA) with α = 0.05
Table 16.8 Case and Morgan design (ETSL) with α = 0.05
Table 16.9 Simon, Wittes and Ellenberg design
Table 16.10 Bryant and Day design

17 Sample size software
Cumulative references

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Tags: David Machin, Michael Campbell, Say Beng Tan, Sze Huey Tan, Sample