[R] R, clinical trials and the FDA

[Marc Schwartz]

I don't mind at all.

Very kind of you Kingsford.

Thanks,

Marc

on 01/11/2009 01:05 PM Kingsford Jones 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...
> 
> 
> 
> On Sun, Jan 11, 2009 at 10:08 AM, Marc Schwartz
> <marc_schwartz at comcast.net> wrote:
> 
> ...
> 
> I strongly believe that the comments regarding R and the FDA are overly
> negative and pessimistic.
> 
> The hurdles to the use of R for clinical trials are shrinking. There has
> been substantive activity over the past several years, both internally
> at the FDA and within the R community to increase R's acceptance in this
> domain.
> 
> At the Joint Statistical Meetings in 2006, Sue Bell from the FDA spoke
> during a session with a presentation entitled Times 'R' A Changing: FDA
> Perspectives on Use of "Open Source". A copy of this presentation is
> available here:
> 
>  http://www.fda.gov/cder/Offices/Biostatistics/Bell.pdf
> 
> In 2007, during an FDA committee meeting reviewing the safety profile of
> Avandia (Rosiglitazone), the internal FDA meta-analysis performed by Joy
> Mele, the FDA statistician, was done using R. A copy of this
> presentation is available here:
>  http://www.fda.gov/ohrms/dockets/ac/07/slides/2007-4308s1-05-fda-mele.ppt
> 
> Given the high profile nature of drug safety issues today, that R was
> used for this analysis by the FDA itself speaks volumes.
> 
> Also in 2007, at the annual R user meeting at Iowa State University, I
> had the pleasure and privilege of Chairing a session on the use of R for
> clinical trials. The speakers included Frank Harrell (well known to R
> users here), Tony Rossini and David James (Novartis Pharmaceuticals) and
> Mat Soukup (FDA statistician). Copies of our presentations are available
> here, a little more than half way down the page:
> 
>  http://user2007.org/program/
> 
> At that meeting, we also introduced a document that has been updated
> since then and approved formally by the R Foundation for Statistical
> Computing. The document provides guidance for the use of R in the
> regulated clinical trials domain, addresses R's compliance with the
> relevant regulations (eg. 21 CFR 11) as well as describing the
> development, testing and quality processes in place for R, also known as
> the Software Development Life Cycle.
> 
> That document is available here:
> 
>  http://www.r-project.org/doc/R-FDA.pdf
> 
> I have heard directly from colleagues in industry that this document has
> provided significant value in their internal discussions regarding
> implementing the use of R within their respective environments and
> assuaging many fears regarding R's use.
> 
> Additionally, presentations regarding the use of open source software
> and R specifically for clinical trials have been made at DIA and other
> industry meetings. This fall, there is a session on the use of R
> scheduled for the FDA's Industry Statistics Workshop in Washington, D.C.
> 
> For those unfamiliar, I would also point out the membership and
> financial donors to the R Foundation for Statistical Computing and take
> note of the plethora of large pharma companies and clinical research
> institutions:
> 
>  http://www.r-project.org/foundation/memberlist.html
> 
> The use of R within this domain is increasing and will only continue to
> progress as R's value becomes increasingly clear to even risk averse
> industry decision makers.
> 
> 
> Regards,
> 
> Marc Schwartz
>