Automating Reproducible, Collaborative Clinical Trial Document Generation with the listdown Package

The conveyance of clinical trial explorations and analysis results from a statistician to a clinical investigator is a critical component of the drug development and clinical research cycle. Automating the process of generating documents for data descriptions, summaries, exploration, and analysis allows the statistician to provide a more comprehensive view of the information captured by a clinical trial, and efficient generation of these documents allows the statistican to focus more on the conceptual development of a trial or trial analysis and less on the implementation of the summaries and results on which decisions are made. This paper explores the use of the listdown package for automating reproducible documents in clinical trials that facilitate the collaboration between statisticians and clinicians as well as defining an analysis pipeline for document generation.

Michael Kane (Yale University) , Xun Jiang (Amgen Inc.) , Simon Urbanek (The University of Aukland)
2021-06-08

Supplementary materials

Supplementary materials are available in addition to this article. It can be downloaded at RJ-2021-051.zip

References

Reuse

Text and figures are licensed under Creative Commons Attribution CC BY 4.0. The figures that have been reused from other sources don't fall under this license and can be recognized by a note in their caption: "Figure from ...".

Citation

For attribution, please cite this work as

Kane, et al., "Automating Reproducible, Collaborative Clinical Trial Document Generation with the listdown Package", The R Journal, 2021

BibTeX citation

@article{RJ-2021-051,
  author = {Kane, Michael and Jiang, Xun and Urbanek, Simon},
  title = {Automating Reproducible, Collaborative Clinical Trial Document Generation with the listdown Package},
  journal = {The R Journal},
  year = {2021},
  note = {https://doi.org/10.32614/RJ-2021-051},
  doi = {10.32614/RJ-2021-051},
  volume = {13},
  issue = {1},
  issn = {2073-4859},
  pages = {556-562}
}