R as a Game-Changer in Clinical Trial Reporting: Best Practices for TLF Compliance

R as a Game-Changer in Clinical Trial Reporting: Best Practices for TLF Compliance

Arvind Uttiramerur

Programmer Analyst at Thermofisher Scientific, USA

Abstract

In clinical trial reporting, the generation of Tables, Listings, and Figures (TLFs) is crucial for data presentation and regulatory submission. Historically, SAS has been the predominant tool for creating TLFs; however, with the increasing adoption of open-source software in the pharmaceutical industry, R has emerged as a viable alternative. This paper presents a comprehensive approach to creating TLFs using R, focusing on the required R packages, strategies for handling missing values, and methods for rounding numeric values. By leveraging R's capabilities, organizations can achieve greater flexibility and efficiency in their reporting processes, potentially reducing costs associated with software licensing and training. Additionally, the integration of R in clinical workflows can facilitate real-time data analysis and enhance decision-making, positioning R as a powerful tool for the pharmaceutical industry’s evolving landscape. This work demonstrates how R can be effectively used for clinical trial reporting, offering significant advantages compared to traditional tools.

Keywords: R packages, ggplot2, dplyr,R Shiny for clinical trials,  R in clinical trials,   Adverse event tables, Data visualization, Data preparation, Regulatory submission, Tables, Listings, and Figures (TLFs)