[R] R, clinical trials and the FDA

[David M Smith]

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)