Description Usage Arguments Value References Examples
View source: R/SampleSize4ClinicalTrials.R
This package aims to calculate sample size for mean and proportion comparisons in phase 3 clinical trials.
1 
cat 
Type of the outcome for comparison.

design 
The design of the clinical trials.

ratio 
The ratio between number of subjects in experimental drug and that in standard drug. 
alpha 
Type 1 error rate 
power 
Statistical power of the test (1type 2 error rate) 
sigma 
The variance of observed outcomes in both arms (specified in means comparison for continuous outcomes) 
p1 
The response rate of the experimental drug (specified proportion comparison for binary outcomes) 
p2 
The response rate of the standard drug 
theta 
The difference between means or proportions in two arms 
delta 
The prespecified noninferiority or equivalence margin in noninferiority or equivalence trials 
samplesize
Yin, G. (2012). Clinical Trial Design: Bayesian and Frequentist Adaptive Methods. John Wiley & Sons.
1 2 3 4 5  ##Means comparison for continuous outcomes, a noninferiority trial with a noninferiority margin 0.5
##the true treatment difference is assumed to be zero in noninferiority and equivalence trials
ssc(cat="m",design=3,ratio=1,alpha=0.05,power=0.9,sigma=1,theta=0,delta=0.5)
##Proportions comparison for binary outcomes, a superiority trial
ssc(cat="p",design=2,ratio=3,alpha=0.025,power=0.8,p1=0.4,p2=0.2,theta=0.2)

$Category
[1] "Sample size for means comparison"
$Experimental
[1] "Experimental drug:" "69"
$Standard
[1] "Standard drug:" "69"
$Category
[1] "Sample size for proportions comparison"
$Experimental
[1] "Experimental drug:" "159"
$Standard
[1] "Standard drug:" "53"
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