Re-envisioning Clinical Content Delivery in the Open Source World


Content delivery in preparation for filing a clinical study report requires robust tooling for quickly and reproducibly compiling analysis of study data. Traditionally, this reproducibility has stemmed from one-time, rigorous validation of a development environment and analytic workflow. More recently, this paradigm has shifted to match modern software development principles, transitioning toward continuous monitoring of software validation and quality. I’ll share our developing perspectives on validation and reproducibility, driven by a need to leverage open source tools. This vision leans on open source software such as R and its package ecosystems, publicly maintained containerized environments like the rocker project and cross-industry risk assessment via the R Validation Hub. By treating analysis as a software process in the content pipeline transforming raw data into analytic results, we can take advantage of the continuous deployment workflows prevalent in the software development world to shorten our filing timelines, while simultaneously delivery a more reproducible product to our health authority partners.

Presented at 2019 Conference