Automated protocol templates with efficient schedule of activities table generation for healthy volunteer trials

Background

The writing of clinical trial protocols that conform to relevant guidelines is a labor- and time-intensive endeavor. An automated clinical trial protocol template generation system for healthy volunteer trials and a web-based schedule of activities (SoA) generator were developed in this study.

Materials and methods

R Markdown was applied as the primary template development tool to automate the creation of a clinical trial protocol template that adheres to the International Council for Harmonization (ICH) M11 guidelines by enabling the adjustment of dynamic variables and facilitating the standardized presentation of relevant data using associated R packages. To ensure broader compatibility, the template was also tested using Quarto, which produced identical outputs with slight modifications to the YAML header. Additionally, a web-based SoA generator (developed with React.js) was created, featuring user-friendly functions for flexible start day adjustments, trial parameter settings, and automatic annotations.

Results

The R Markdown script removed most manual effort in creating healthy volunteer protocol templates, thereby increasing both accuracy and productivity. The system also supports Quarto with minor modifications, providing an alternative for users preferring its framework. The web-based SoA generator also demonstrated significant advantages over conventional methods, as it reduced human errors and required less time compared to manually generating SoAs in Word documents.

Conclusions

This study introduces a novel automated protocol template generation process using R Markdown as the primary tool, with Quarto compatibility confirmed, and a web-based SoA generator designed specifically for healthy volunteer trials. By improving the efficiency and accuracy of clinical trial document preparation, these tools have the potential to advance the drug development process.