Ricardo, Tony Rossini (Novartis) provided a very good post on point (3) below (which you may have already read): http://tolstoy.newcastle.edu.au/R/e2/help/07/08/23820.html.
Regards, -Cody -----Original Message----- From: [EMAIL PROTECTED] [mailto:[EMAIL PROTECTED] On Behalf Of Ricardo Pietrobon Sent: Sunday, October 07, 2007 5:41 PM To: [EMAIL PROTECTED] Subject: [R] R and FDA trials 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. would be interested in opinions on how to respond to these comments Ricardo ______________________________________________ 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.
