A Milestone and a new Frontier in R-based Regulatory Submissions
The R Consortium is delighted to share knowledge of the successful submission of an R-based test submission Pilot 3 package through the FDA eCTD gateway by the R Submissions Working Group. This groundbreaking achievement marks one of the early publicly available R-based FDA submission packages, including R scripts for generating analysis data model (ADaM) datasets and tables, listings, and figures (TLFs). The package adheres to eCTD specifications and serves as a valuable reference for future R-based regulatory submissions.
The Pilot 3 test submission package, along with installation instructions and required components, can be accessed on the R Consortium's webpage[^1^]. By leveraging open-source R packages and the proprietary {pilot3utils} R package, the submission package demonstrates the potential of R in streamlining the submission process. In this talk & demo, we want to share more background about the test Pilot packages leading up to this Pilot 3 submission as well demonstrate the set-up and workflow towards submission to the FDA.
The R Consortium R Submissions Working Group is dedicated to improving practices for R-based clinical trial regulatory submissions. With a focus on the pharmaceutical industry and research institutions, the group aims to address the hesitancy surrounding R-based submissions by providing working examples and identifying potential gaps. All materials, including submission examples and communications, are publicly available on the R Consortium's GitHub webpage[^1^].
Links: rconsortium.gi...
Joel Laxamana, Roche / Genentech
Joel Laxamana is a Data Science Project Lead in the Product Development Data Sciences group at Genentech, A member of Roche. Joel joined in December of 2013 as a Analytical Data Scientist with a focus on Statistical Programming. He started in Oncology, working on both early and late phase development studies. He is currently working in late phase Opthamology. He has a special interest in exploring next generation tools and new ways of working in the pharma regulatory setting, supporting the use of open source software and open collaboration in pharma.
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