useR! 2024

In the ever-evolving world of clinical trial design, the R package "rpact" (available on CRAN and GitHub) has emerged as a pivotal tool for confirmatory adaptive clinical trials, crafted specifically to meet the stringent demands of regulatory requirements. This presentation will dive into the core concepts and challenges encountered over the past six years since the project's inception, which began with successful crowdfunding. Our solution was a robust validation framework inspired by GAMP 5 principles, incorporating comprehensive validation documentation, tools, and utility packages from the outset. This approach enabled high automation levels in the validation process, making development feasible with a minimal team. A key concept in our methodology is the use of template-based unit tests. These templates not only generate "testthat" test cases but also enable automation of the creation of test plans and references to function specifications, with the test protocol linking back to individual test cases. This seamless integration of testing and documentation has made "rpact" a trusted and highly accepted package in the pharmaceutical industry.