ssc_propcomp {SampleSize4ClinicalTrials}

Sample Size Calculation for the Comparison of Proportions in Phase III Clinical Trials

Description

This function aims to calculate sample size for the comparison of proportions in Phase III clinical trials.

Usage

ssc_propcomp(design, ratio, alpha, power, p1, p2, delta)

Arguments

design

The design of the clinical trials.
1L
Testing for equality
2L
Superiority trial
3L
Non-inferiority trial
4L
Equivalence trial.

ratio

The ratio between the number of subjects in the treatment arm and that in the control arm.

alpha

Type I error rate

power

Statistical power of the test (1-type II error rate)

p1

The true mean response rate of the treatment arm

p2

The true mean response rate of the control arm

delta

The prespecified superiority, non-inferiority or equivalence margin

Value

samplesize

References

Chow S, Shao J, Wang H. 2008. Sample Size Calculations in Clinical Research. 2nd Ed. Chapman & Hall/CRC Biostatistics Series.

Yin, G. 2012. Clinical Trial Design: Bayesian and Frequentist Adaptive Methods. John Wiley & Sons.

Examples

##The comparison of proportions, an equivalence trial and the equivalence margin is 0.2
ssc_propcomp(design = 4L, ratio = 1, alpha = 0.05, power = 0.8, p1 = 0.75, p2 = 0.80, delta = 0.2)