SampleSize4ClinicalTrials (version 0.2.3)

ssc_meancomp: Sample Size Calculation for the Comparison of Means in Phase III Clinical Trials

Description

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

Usage

ssc_meancomp(design, ratio, alpha, power, sd, theta, 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)

sd

The standard deviation of observed outcomes in both arms

theta

The true mean difference between two arms

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

# NOT RUN {
##The comparison of means, a non-inferiority trial and the non-inferiority margin is -0.05
ssc_meancomp(design = 3L, ratio = 1, alpha = 0.05, power = 0.8, sd = 0.1, theta = 0, delta = -0.05)

# }