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

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.