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Author Spotlight: Advances in Evaluating Human Lung Epithelial Cells' Response to Metal-Organic Frameworks

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Electronic common technical document submission with analysis using R.

Yujie Zhao¹, Nan Xiao, Keaven Anderson

¹Department of Biostatistics and Research Decision Sciences, Merck & Co., Inc, Rahway, NJ, USA.

Clinical Trials (London, England)

|September 28, 2022

Summary

This summary is machine-generated.

A new R package, pkglite, simplifies regulatory submissions by packaging R analysis scripts and dependencies into a self-contained file. This tool facilitates reproducible clinical trial reporting following electronic common technical document specifications.

Keywords:

R packages clinical trial regulatory submission reproducible research

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Area of Science:

Regulatory Science
Computational Statistics
Pharmaceutical Development

Background:

Regulatory submissions for medicinal products require standardized formats like the electronic common technical document (eCTD).
There's a growing use of R for clinical trial analysis and reporting, necessitating inclusion of R code and dependencies.
A gap exists in tools and guidance for preparing R programs compliant with eCTD specifications for regulatory submissions.

Purpose of the Study:

To introduce pkglite, an R package designed to streamline the preparation of R-based regulatory submissions.
To provide a tool that addresses the unmet need for managing R code and dependencies within the eCTD framework.

Main Methods:

Developed pkglite, an R package available on CRAN and GitHub, to convert R analysis scripts and proprietary dependencies into a compact, text-based file.
Demonstrated the workflow using pkglite for preparing submission programs compliant with eCTD specifications through a mock-up example.

Main Results:

pkglite enables the creation of self-contained, reproducible R submission packages that are easy to restore, transfer, and review.
The package functions as a tool for packing/unpacking R packages and their dependencies, and as a standard with an open file format.
A mock-up example illustrated the practical application of pkglite in an eCTD-compliant workflow.

Conclusions:

The pkglite package and its workflow facilitate the submission of well-organized R scripts adhering to eCTD specifications.
This approach has been successfully utilized in the first publicly available R-based submission to the US Food and Drug Administration.