R, clinical trials and the FDA
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