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Merge pull request #367 from arfon/patch-1
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Minor fixes to JOSS paper
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nociale authored Jun 15, 2022
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index: 1
- name: Data and Statistical Sciences, Pharma Development, Roche, Basel, Switzerland
index: 2
citation_author: Gower-Page, Noci, and Wolbers
date: \today
bibliography: references.bib
output: rticles::joss_article
journal: JOSS
---



# Summary

Many randomized controlled clinical trials compare a continuous outcome variable that is assessed longitudinally at scheduled follow-up visits between subjects assigned to a intervention treatment group and those assigned to a control group.
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# Statement of need

`rbmi` is a flexible `R` package designed to support the analysis of randomized clinical trials with continuous longitudinal endpoints.
Both conventional MI methods based on Bayesian posterior draws and novel methods based on maximum likelihood estimation and re-sampling (as described in @vanHippelBartlett2021 and @Wolbers2021) are implemented. `rbmi` was designed for statisticians from both academic clinical research units and pharmaceutical industry. To our knowledge, a comprehensive and fully unit-tested `R` implementation of such approaches is still lacking. An established software implementation of reference-based imputation in SAS are the so-called "five macros" [@FiveMacros]. An alternative `R` implementation which is currently under development is the R package `RefBasedMI`[@RefbasedMIpackage].
Both conventional MI methods based on Bayesian posterior draws and novel methods based on maximum likelihood estimation and re-sampling (as described in @vanHippelBartlett2021 and @Wolbers2021) are implemented. `rbmi` was designed for statisticians from both academic clinical research units and pharmaceutical industry. To our knowledge, a comprehensive and fully unit-tested `R` implementation of such approaches is still lacking. An established software implementation of reference-based imputation in SAS are the so-called "five macros" [@FiveMacros]. An alternative `R` implementation which is currently under development is the R package `RefBasedMI` [@RefbasedMIpackage].

# `rbmi` workflow

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Additionally comparisons are made to similar software (namely the so-called "five macros" [@FiveMacros] SAS implementation) to ensure consistency of results as well as to simulated datasets with known values.
To date, `rbmi` has been used in two simulation studies reported in @Wolbers2021 and @Noci2021.


# Author contributions and acknowledgements

Craig Gower-Page and Alessandro Noci are the primary developers of the `rbmi` package. Marcel Wolbers initiated the project (jointly with Paul Delmar), specified the statistical methods and contributed to the documentation and vignettes.
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