Rense Nieuwenhuis » clinical trials http://www.rensenieuwenhuis.nl "The extra-ordinary lies within the curve of normality" Thu, 12 Mar 2026 14:58:15 +0000 en-US hourly 1 http://wordpress.org/?v=4.2.2 R-Project in Clinical Trials http://www.rensenieuwenhuis.nl/r-project-in-clinical-trials/ http://www.rensenieuwenhuis.nl/r-project-in-clinical-trials/#comments Tue, 02 Sep 2008 10:00:43 +0000 http://www.rensenieuwenhuis.nl/?p=624 "R: Regulatory Compliance and Validation Issues. A Guidance Document for the Use of R in Regulated Clinical Trial Environments" ]]>
Can we trust free software? Or better: would you trust your health to software that nobody paid for? Software that is open to use and adapt by whomever wants to? Well, the use of the free R-Project in clinical trials is considered more and more seriously. Recently, The R Foundation for Statistical Computing unanimously adopted a document titled: “R: Regulatory Compliance and Validation Issues. A Guidance Document for the Use of R in Regulated Clinical Trial Environments”

From the announcement:

The document provides extensive background and detailed guidance for the
use of R within the regulated framework of human clinical trials,
covering GxP and 21 CFR Part 11 issues. This document should serve R
users as a key reference for their internal regulatory activities
relating to the use of statistical software for clinical trials.

One or two years ago, there was some discussion on the use of R-Project in clinical trials on the R Help mailing lists. General concerns were that employers, journals, or (in the United States) the FDA would not accept studies performed using R-Project. Perhaps this document will help in gaining more acceptance of this excellent piece of analytic software.

If you’re working in a clinical or medical setting, please let me know: do you or your colleagues use R-Project? Or, if not, what type of statistical software do you use?

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