Preface to the Second Edition

Preface to the First Edition

1 Basic Design Considerations

2 The Normal Distribution

Table 2.1 The Normal distribution function

Table 2.2 Percentage points of the Normal distribution

Table 2.3 Values of THETA(1 - ALPHA, 1 - BETA)

3 Comparing Independent Groups for Binary, Ordered Categorical and Continuous Data

Table 3.1 Sample sizes for comparison of proportions

Table 3.2 Multiplying factor for comparison of proportions when using an exact or continuity-corrected X(2) test

Table 3.3 Values of 6/THETA(1 - ALPHA, 1 - BETA)/(log OR)(2) with two-sided ALPHA = 5%

Table 3.4 Correction factor for ordered categorical data

Table 3.5 Sample sizes for the two sample t-test

Table 3.6 Sample sizes for the one sample t-test

Table 3.7 Multiplying factor for repeated measures designs

4 Comparing Paired Groups for Binary, Ordered Categorical and Continuous Outcomes

Table 4.1 Sample sizes for paired binary observation for McNemar's test

Table 4.2 Sample sizes for paired continuous data

5 Demonstrating Equivalence

Table 5.1 Sample sizes for testing the equivalence of proportions

Table 5.2 Sample sizes for difference between means in bioequivalence studies

Table 5.3 Sample sizes for ratio of two means in bioequivalence studies

6 Confidence Intervals

Table 6.1 Sample sizes for a given confidence interval

Table 6.2 Multiplying factor for sampling from a finite population

7 Post-Marketing Surveillance

Table 7.1 Sample sizes required to observe a single adverse reaction with a given probability and anticipated incidence

Table 7.2 Sample sizes for detection of a specified adverse reaction, background incidence known

Table 7.3 Sample sizes for detection of a specified adverse reaction, background incidence unknown

Table 7.4 Number of cases to be observed in a case-control study

8 The Correlation Coefficient

Table 8.1 Sample sizes for detecting a statistically significant correlation coefficient

9 Comparing Two Survival Curves

Table 9.1 Survival rate PI(2) corresponding to a given HR and survival rate PI(1)

Table 9.2 Number of critical events for comparison of two exponential survival distributions

Table 9.3 Duration of study required to compare two exponential survival distributions

Table 9.4 Number of critical events for comparison of survival rates (logrank test)

Table 9.5 Number of subjects for comparison of survival rates (logrank test)

10 Phase II Trials

Table 10.1 Sample sizes required for Fleming's single-stage Phase II procedure

Table 10.2 Probability of a given number of successive treatment failures

Table 10.3 Number of patients required for the first stage of a Gehan Phase II trial design

Table 10.4 Additional number of patients required for the second stage of a Gehan Phase II trial

Table 10.5 Number of patients required for Simon's two-stage optimal and minimax designs

11 Observer Agreement Studies

Table 11.1 Sample sizes for observer agreement studies designed to estimate the proportion of disagreements for a given confidence interval width

Table 11.2 Sample sizes for observer agreement studies with duplicate assessments

Table 11.3 Total number of subjects, each assessed twice by each observer, required to assess the true disagreement for a given confidence interval width

12 Randomization

Table 12.1 10 000 random numbers

Cumulative References

Author Index

Subject Index