R, clinical trials and the FDA
On Sun, Jan 11, 2009 at 11:05 AM, Kingsford Jones
<kingsfordjones at gmail.com> wrote:
I hope that Marc doesn't mind, but I felt that part of his recent post was important enough to deserve it's own subject line rather then being lost in a 60-msg-long thread...
I also wanted to thank Marc for this wealth of information on using R in clinical trials. I particularly want to recommend the "R: Regulatory Compliance and Validation Issues" document at http://www.r-project.org/certification.html . Even if you're not looking to validate R for 21CFR11 compliance, this document is an excellent description of R's world-class software development process. With this, and the documented use of R by the FDA itself and within pharma companies for clinical trials, I hope we can settle the "Is R Validated?" question at long last. Thanks go to the authors (Marc Schwartz, Frank Harrell, Tony Rossini and Ian Francis) and the R Foundation generally for putting this together. By the way, if (or a skeptical colleague) needs a more detailed answer to the "Is R Validated?" question, I expand upon the information Marc provided here: http://blog.revolution-computing.com/2009/01/analyzing-clinical-trial-data-with-r.html # David Smith
David M Smith <david at revolution-computing.com> Director of Community, REvolution Computing www.revolution-computing.com Tel: +1 (206) 577-4778 x3203 (Seattle, USA)