ssc: Sample Size Calculation for Mean and Proportion Comparisons...

Description Usage Arguments Value References Examples

View source: R/SampleSize4ClinicalTrials.R

Description

This package aims to calculate sample size for mean and proportion comparisons in phase 3 clinical trials.

Usage

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ssc(cat=c("m","p"),design=c(1,2,3,4),ratio,alpha,power,sigma,p1,p2,theta,delta)

Arguments

cat

Type of the outcome for comparison.
"m"
stands for means comparison.
"p"
stands for proportions comparison.

design

The design of the clinical trials.
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Testing for equality
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Superiority trial
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Noninferiority trial
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Equivalence trial.

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 (1-type 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

Value

samplesize

References

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

Examples

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##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)

SampleSize4ClinicalTrials documentation built on Sept. 17, 2017, 5:02 p.m.