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

Authors

Michael Kane, Yale University
Xun Jiang, Amgen Inc.
Simon Urbanek, The University of Aukland

Date of this Version

6-2021

Document Type

Article

Citation

The R Journal (June 2021) 13(1); Editor: Dianne Cook

Comments

Copyright 2021, The R Foundation. Open access material. License: CC BY 4.0 International

Abstract

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.