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| Main Authors: | , , , , , |
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| Format: | Preprint |
| Published: |
2024
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| Subjects: | |
| Online Access: | https://arxiv.org/abs/2407.11342 |
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| _version_ | 1866914315032854528 |
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| author | Soltanifar, Mohsen Lee, Chel Hee Shirazi, Amin Behnke, Martha Raymond-Loher, Ilfra Dagne, Getachew A. |
| author_facet | Soltanifar, Mohsen Lee, Chel Hee Shirazi, Amin Behnke, Martha Raymond-Loher, Ilfra Dagne, Getachew A. |
| contents | 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. |
| format | Preprint |
| id |
arxiv_https___arxiv_org_abs_2407_11342 |
| institution | arXiv |
| publishDate | 2024 |
| record_format | arxiv |
| spellingShingle | GenTwoArmsTrialSize: An R Statistical Software Package to estimate Generalized Two Arms Randomized Clinical Trial Sample Size Soltanifar, Mohsen Lee, Chel Hee Shirazi, Amin Behnke, Martha Raymond-Loher, Ilfra Dagne, Getachew A. Methodology 62-04, 62-08, 62K05 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. |
| title | GenTwoArmsTrialSize: An R Statistical Software Package to estimate Generalized Two Arms Randomized Clinical Trial Sample Size |
| topic | Methodology 62-04, 62-08, 62K05 |
| url | https://arxiv.org/abs/2407.11342 |