Mohsen Soltanifar

GenTwoArmsTrialSize: An R Statistical Software Package to estimate Generalized Two Arms Clinical Trial Sample Size

Lighting Talk, 1:50-1:55

The precise calculation of sample sizes is a crucial aspect in the design of two-arms clinical trials, particularly for pharmaceutical statisticians. While various R statistical software packages have been developed by researchers to estimate required sample sizes under different assumptions, there has been a notable absence of a standalone R statistical software package that allows researchers to comprehensively estimate sample sizes under generalized scenarios. This talk introduces the R statistical software package “GenTwoArmsTrialSize,” available on the CRAN, designed for estimating the required sample size in two-arm clinical trials. The package incorporates four endpoint types, two trial treatment designs, four types of hypothesis tests, as well as considerations for noncompliance and loss of follow-up, providing researchers with the capability to estimate sample sizes across 24 scenarios. To facilitate understanding of the estimation process and illuminate the impact of noncompliance and loss of follow-up on the size and variability of estimations, the paper includes a practical example covering four scenarios. The discussion encompasses the package‚Äôs limitations and outlines directions for future extensions and improvements.

Mohsen Soltanifar
Pronouns: he/him
Vancouver, BC, Canada
Mohsen Soltanifar is an accredited statistician by Statistical Society of Canada with 3.0+ years post-PhD level experience in CRO/Pharma; 5.0+ years experience in Healthcare and 4.0+ part time teaching experience in North American academia. His main area of interest in statistics are Clinical Trials with focus of R software applications in their design, analysis, and result presentations.