| Title: | Sample Size Calculation for the Comparison of Means or Proportions in Phase III Clinical Trials |
|---|---|
| Description: | There are four categories of Phase III clinical trials according to different research goals, including (1) Testing for equality, (2) Superiority trial, (3) Non-inferiority trial, and (4) Equivalence trial. This package aims to help researchers to calculate sample size when comparing means or proportions in Phase III clinical trials with different research goals. |
| Authors: | Hongchao Qi, Fang Zhu |
| Maintainer: | Hongchao Qi <[email protected]> |
| License: | GPL-3 |
| Version: | 0.2.3 |
| Built: | 2024-11-16 04:03:32 UTC |
| Source: | https://github.com/cran/SampleSize4ClinicalTrials |
There are four categories for Phase III clinical trials according to different research goals, including (1) Testing for equality, (2) Superiority trial, (3) Non-inferiority trial, and (4) Equivalence trial. This package aims to help researchers to calculate sample size when comparing means or proportions in Phase III clinical trials with different research goals.
Hongchao Qi, Fang Zhu
This function aims to calculate sample size for the comparison of means in Phase III clinical trials.
ssc_meancomp(design, ratio, alpha, power, sd, theta, delta)ssc_meancomp(design, ratio, alpha, power, sd, theta, delta)
design |
The design of the clinical trials.
|
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 |
samplesize
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.
##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)##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)
This function aims to calculate sample size for the comparison of proportions in Phase III clinical trials.
ssc_propcomp(design, ratio, alpha, power, p1, p2, delta)ssc_propcomp(design, ratio, alpha, power, p1, p2, delta)
design |
The design of the clinical trials.
|
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 |
samplesize
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.
##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)##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)