Global consumers benefit from having access to safe and advanced pharmaceutical systems. Such flexibility in the submission process would promote the wider adoption of R within the industry, particularly for regulatory submissions, fostering innovation and streamlining regulatory procedures. If accepted by the FDA, this achievement could have far-reaching implications, demonstrating the feasibility of submitting plain R code and Shiny apps without the need to wrap them into R packages. The successful rewriting of the Pilot 2 app using the Rhino framework holds significant potential for Shiny users in the life science industry. Broader Implications of Rhino, R Programming, and Clinical Trials ![]() This approach simulated the same submission approach used for the Pilot 2 app. ![]() ![]() The ` pkglite::pack()` function was utilized to pack the Shiny app into a text file suitable for submission through the eCTD gateway. This involved creating a simple DESCRIPTION file with just a package name. Learnings from the Rewrite Processĭuring the rewriting process, a technical solution was developed to submit the non-R package Shiny app using the Rhino framework. Our FDA pilot app can be found on our Appsilon R Shiny Demo Gallery, providing a practical demonstration of the capabilities and advantages of a Rhino app. The motivation for selecting the Rhino framework to rewrite the Pilot 2 app was to offer an example of a Shiny app submission that is not an R package. The motivation behind rewriting the app with Rhino While there are other projects aimed at improving the structure of Shiny applications, exploring the Rhino documentation will provide insights into how Rhino differentiates itself from these alternatives. Its capabilities align with the needs of these industries, ensuring compliance and streamlining the development of Shiny applications. The Rhino framework is exceptionally well-suited for highly regulated environments, particularly those involved in regulatory submissions and drug development processes. Pilot 2 expanded upon Pilot 1 by including a Shiny app developed using the, configuration management with config, Sass and JavaScript bundling with ES6 support via Node.js. Pilot 1 focused on showcasing an R-based submission containing common analyses within the current FDA e-submission system and process. The RConsortium working group has initiated several pilots aimed at demonstrating the capabilities of R and Shiny apps in various FDA submission scenarios. RConsortium Submissions Working Group Pilots Background of the Pilots This, in turn, fosters a more collaborative and transparent environment within the industry. The efforts of the RConsortium working group in showcasing R-based submissions not only emphasize the potential of R but also highlight the possibility of revolutionizing the management and submission of clinical trial data. However, R’s open-source nature provides significant advantages in terms of reproducibility and accessibility. Historically, the pharmaceutical industry has heavily relied on SAS. R has been gaining traction in the life science industry, emerging as a powerful alternative to traditional tools like SAS for data analysis, visualization, and statistical modeling. static/35215a117d1bc17fac2179f059c3709f/rhino_fda_pilot_r_shiny_app_e-ctd.webm Importance of R in the Life Science Industry and FDA Submissions
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