Building a Standardised Statistical Reporting Toolbox in an Academic Oncology Clinical Trials Unit: The grstat R Package

TL;DR

This paper introduces grstat, an R package that standardizes statistical analysis workflows in an academic oncology clinical trials unit, enhancing reproducibility, collaboration, and efficiency through structured development and governance.

Contribution

The paper presents a novel organizational framework and an open-source R package that standardizes and validates statistical workflows in an academic clinical trials setting.

Findings

Improved workflow efficiency and reproducibility.

Enhanced collaboration through shared tools and governance.

Open-source development supports transparency and collective ownership.

Abstract

Academic Clinical Trial Units frequently face fragmented statistical workflows, leading to duplicated effort, limited collaboration, and inconsistent analytical practices. To address these challenges within an oncology Clinical Trial Unit, we developed grstat, an R package providing a standardised set of tools for routine statistical analyses. Beyond the software itself, the development of grstat is embedded in a structured organisational framework combining formal request tracking, peer-reviewed development, automated testing, and staged validation of new functionalities. The package is intentionally opinionated, reflecting shared practices agreed upon within the unit, and evolves through iterative use in real-world projects. Its development as an open-source project on GitHub supports transparent workflows, collective code ownership, and traceable decision-making. While primarily designed for internal use, this work illustrates a transferable approach to organising, validating, and maintaining a shared analytical toolbox in an academic setting. By coupling technical implementation with governance and validation principles, grstat supports efficiency, reproducibility, and long-term maintainability of biostatistical workflows, and may serve as a source of inspiration for other Clinical Trial Units facing similar organisational challenges.