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_schwa...@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 > ______________________________________________ R-help@r-project.org mailing list https://stat.ethz.ch/mailman/listinfo/r-help PLEASE do read the posting guide http://www.R-project.org/posting-guide.html and provide commented, minimal, self-contained, reproducible code.
