BayesCTDesign: An R Package for Bayesian Trial Design Using Historical Control Data

Abstract

This article introduces the R package BayesCTDesign for two-arm randomized Bayesian trial design using historical control data when available, and simple two-arm randomized Bayesian trial design when historical control data is not available. The package BayesCTDesign, which is available from the Comprehensive R Archive Network, has two simulation functions, historic_sim() and simple_sim() for studying trial characteristics under user-defined scenarios, and two methods print() and plot() for displaying summaries of the simulated trial characteristics. The package BayesCTDesign works with two-arm trials with equal sample sizes per arm. The package BayesCTDesign allows a user to study Gaussian, Poisson, Bernoulli, Weibull, lognormal, and piecewise exponential outcomes. Power for two-sided hypothesis tests at a user-defined α is estimated via simulation using a test within each simulation replication that involves comparing a 95% credible interval for the outcome specific treatment effect measure to the null case value. If the 95% credible interval excludes the null case value, then the null hypothesis is rejected, else the null hypothesis is accepted. In the article, the idea of including historical control data in a Bayesian analysis is reviewed, the estimation process of BayesCTDesign is explained, and the user interface is described. Finally, the BayesCTDesign is illustrated via several examples.

Keywords

• bayesian statistics
• clinical trials
• historical controls
• power prior
• r