Hi All, I'm excited to see that R-Core has released the document "R: Regulatory Compliance and Validation Issues A Guidance Document for the Use of R in Regulated Clinical Trial Environments" (http://www.r-project.org/doc/R-FDA.pdf). I know it represents a great deal of effort on the part of R core, and it has taken many months to achieve.
Random Technologies, LLC (http://random-technologies-llc.com) has been extended this work to cover additional R packages, as well as offering additional documentation, products, and tools that facilitate use of R for mission-critical and regulated contexts. (Lots of this work falls into the "Make your *boss* happy" context, <grin>). These efforts are supported by the sale of support contracts and related services. We are very interested in working with R users and developers to identify additional 1) packages, 2) features, and 3) documents which will (with appropriate documentation and testing, of course) make R easier to use (both functionally and politically) for FDA sumbissions. Please send us your suggestions and comments at <[EMAIL PROTECTED] technologies-llc.com> -G Gregory R. Warnes, Ph.D. Chief Scientist Random Technologies, LLC. http://random-technologies-llc.com On Oct 8, 2007, at 8:54AM , Marc Schwartz wrote: > On Sun, 2007-10-07 at 21:25 -0500, Frank E Harrell Jr wrote: >> Ricardo Pietrobon wrote: >>> Yesterday I just noticed the new document on R and regulatory >>> aspects >>> for biomedical research posted at >>> http://www.r-project.org/doc/R-FDA.pdf >>> >>> Coming from an institution that performs a large number of clinical >>> trials for FDA and being an advocate of R myself, I have found that >>> the following issues usually come up when discussing the use of R >>> for >>> FDA trials: >>> >>> 1. Most FDA submissions come down to a series of r x k tables, >>> and it >>> is hard to claim that one system is better than another for that. >>> >>> 2. Data is to be submitted to the FDA in SAS (considered by many as >>> the industry standard) or CDISC XML formats (http://www.cdisc.org/); >>> there are pretty good SAS tools for that; does R have comparable? >>> >>> 3. Some packages in R provide acknowledgedly better functionality >>> than >>> their SAS-equivalent, but an entire FDA validation would have to >>> occur >>> each time an enhancement is made to the R package because often an >>> enhancement breaks something else or the syntax would change from >>> one >>> release to another. >> >> Your item 3. is up to the company's policy. FDA does not require >> it and >> the word "validation" is not well defined in this context. No >> package >> does a complete validation any time any piece of the package is >> enhanced. >> >> Frank > > Just to augment Frank's response: > > With respect to point number 2, I believe the only R based package > that > offers the ability to write SAS XPORT format files at this point is > the > SASxport CRAN package by Greg Warnes et al. There are several, > including > Frank's Hmisc package and the standard foreign package that will read > XPORT files. > > Keep in mind that it is the SAS XPORT files, not the proprietary SAS > files, that the FDA wants, since the XPORT format is openly > documented. > > There are other third party packages, such as DBMS/Copy and > Stat/Transfer, that will also write XPORT format files. > > At some point, CDISC based exports will likely need to be looked at by > one or more folks motivated to do so. In the mean time, you would need > to consider third party tools for that. My recollection of Mat > Soukup's > comments from our panel at useR back in August, is that the FDA itself > is not yet at the point where CDISC based file exchanges are without > issue. > > Finally, bear in mind that the document to which you refer covers > specifically listed packages released via the R Foundation. See > Section > 2 of the document. Other CRAN/non-CRAN R packages are not covered. In > either case, you would need to engage in appropriate risk mitigation > processes when using those and as Frank notes, these would be internal > procedures and policies as deemed appropriate within the GxP > framework. > > HTH, > > 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. ______________________________________________ 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.
