PS18: Harnessing the Power of Open Source and R to Drive Statistical Innovation and Beyond

Since the past decade, most statistical innovations (some widely used notable ones such as rbest, gsdesign, mcpmod, rpact, and many more) are R-based and are open sourced for broad public adoption and use. However, for majority of clinical trial reporting and submission, SAS is still used as the primary programming language. There is a growing consensus across the industry, that use of R based tools, such that RShiny, can provide enormous value and boost efficiency in how biometrics/biostatistics departments add value to the clinical drug development. The success of open-source solutions like Teal, Cardinal, Admiral, etc. speaks to the need of the hour and why we will benefit in exploring and understanding the path to opensource and R based clinical development and trial work. Additionally, with the blurring lines between traditional statistics and statistical programming leading to modern-day data science, we are in a new era; where many so-called industry statisticians and statistical programmers are keen to harness these new tools and approaches, to provide enhanced value to overall clinical drug development. Whether it's blinded monitoring of data for quality during conduct, or early detection of safety signals, or to presenting clinical trial results using an interactive app to enable fast exploration and drive efficiency and turnaround time for important stakeholders. Lastly, we have also seen a few examples of R-based submissions to FDA where it has been favorably received. But enabling such a transformation in a broad scale, requires many considerations: right infrastructure, right tools, upskilling of colleagues, community building, right governance, are some of the key factors. In this session, we will bring experts who are leading such global transformations across different organizations and hear from FDA expert who will share their thoughts on acceptability and experience of R/Open Source based submissions. The session will provide an overview of the current state of the art, present the challenges, point to the learnings and the adopted solutions. We will discuss the opportunities for the future and what should we expect to see. This will stimulate discussion and collaboration among industry and regulators who are interested in advancing R and open-source solutions to broader adoption across the industry and regulatory.