2024/07/16 by Mohsen Soltanifar, Chel Hee Lee, Soltanifar, Mohsen +8
Mathematics · #62-04 #62-08 #62K05 #FOS: Computer and information sciences #Methodology (stat.ME) #Statistical Methods in Clinical Trials
paper · pdf · doi:10.48550/arxiv.2407.11342
openalex publication_date 2024/07/16 · openalex created_date 2024/10/26 · openalex updated_date 2026/07/28
The precise calculation of sample sizes is a crucial aspect in the design of 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 paper introduces the R statistical software package "GenTwoArmsTrialSize" available on the Comprehensive R Archive Network (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 four hypothetical examples and one applied example. The discussion encompasses the package's limitations and outlines directions for future extensions and improvements.