One point that is missing in this discussion is ease of review by the statistician at the FDA. As a statistician in clinical trials, you want to make it as easy as possible for your colleague at the FDA to do their job, so you put the programs in a format that they are more likely to find useful. As more reviewing statisticians are familiar with SAS than with other statistical packages/languages, I feel more comfortable sending a submission in SAS.
Reviewers do use the programs in a filing that were written for creation of data sets and analysis to check for correct variable definitions and appropriate analyses. If the programs are written in a package/language that the reviewer understands they can get their job done easier. Given this, I have used S-Plus in regulatory work where it was clearly stronger--at some point I hope to use R where it adds a clear benefit. Of course 95% of the statistical analyses that are performed for regulatory submission can probably be done just as well with any of the major statistical package/languages available. $0.02 --Matt Matt Austin Statistician Amgen One Amgen Center Drive M/S 24-2-C Thousand Oaks CA 93021 (805) 447 - 7431 > -----Original Message----- > From: [EMAIL PROTECTED] > [mailto:[EMAIL PROTECTED] Behalf Of Marc Schwartz > Sent: Friday, December 17, 2004 16:19 PM > To: Alexander C Cambon > Cc: R-Help; Douglas Bates > Subject: Re: [R] SAS or R software > > > On Fri, 2004-12-17 at 17:11 -0500, Alexander C Cambon wrote: > > I apologize for adding this so late to the "SAS or R software " > > thread. > > This is a question, not a reply, but it seems to me to fit in well > > with > > the subject of this thread. > > > > I would like to know anyone's experiences in the following two areas > > below. I should add I have no experience myself in these areas: > > > > 1) Migrating from SAS to R in the choice of statistical > software used > > for FDA reporting. > > You will find that to be a non-issue from the FDA's perspective. This > has been discussed here with some frequency. If you search > the archives > you will find comments from Frank Harrell and others. > > The FDA does not and cannot endorse a particular software product. Nor > does it validate any statistical software for a specific purpose. They > do need to be able to reproduce the results, which means they need to > know what software product was used, which version and on > what platform, > etc. > > The SAS XPORT Transport Format (which is openly defined and > documented), > has been used for the transfer of data sets and has been available in > many statistical products. > > There have been a variety of activities (CDISC, HL-7, etc) > regarding the > electronic submission of data to the FDA. Some additional > information is > here: > > http://www.fda.gov/cder/regulatory/ersr/default.htm > > and here: > > http://www.cdisc.org/news/index.html > > Any other issues impacting the selection of a particular statistical > application are more likely to be political within your working > environment and FUD. > > As you are likely aware, other statistically relevant issues are > contained in various ICH guidance documents regarding GCP > considerations > and principles for clinical trials: > > http://www.ich.org/[EMAIL PROTECTED]&@_TEMPLATE=272 > > > Keep in mind also that one big advantage R has (in my mind) is the use > of Sweave for the reproducible generation of reports, which > to an extent > are self-documenting. > > > > (For example, was there more effort involved in areas of > > documentation, revision tracking, or validation of software codes? > > Since the FDA's role with computer software and validation has been > raised before, the following documents cover many of these areas. The > list is not meant to be exhaustive, but should give a flavor in this > domain. > > There are specific guidance documents by the FDA pertaining > to software > that is contained in a medical device (ie. the firmware in a pacemaker > or medical monitoring equipment) or is used to develop a > medical device. > The current guidance in this case is here: > > http://www.fda.gov/cdrh/comp/guidance/938.html > > Other guidance pertains to 21 CFR 11, which addresses data management > systems used for clinical trials and covers issues such as electronic > signatures, audit trails and the like. A guidance document for that is > here: > > http://www.fda.gov/cder/guidance/5667fnl.htm > > Keep in mind, from a perspective standpoint, that even MS Excel and > Access can be made to be 21 CFR 11 compliant and there are companies > whose business is focused on just that task. > > There is also a general guidance document for computer systems used in > clinical trials here: > > http://www.fda.gov/ora/compliance_ref/bimo/ffinalcct.htm > > Though it is to be superseded by a draft document here: > > http://www.fda.gov/cder/guidance/6032dft.htm > > > > 2) Migrating from SAS to R in the choice of statistical > software used > > for NIH reporting (or other US or non-US) government agencies) . > > Same here to my knowledge. > > As I was typing this, I see Frank just responded. > > I also just noted Doug's post, so perhaps some of the above > information > will be helpful in clarifying some of his questions as well. > > I believe that the above is factually correct, but if someone knows > anything to not be so, please correct me. > > HTH, > > Marc Schwartz > > ______________________________________________ > [EMAIL PROTECTED] mailing list > https://stat.ethz.ch/mailman/listinfo/r-help > PLEASE do read the posting guide! > http://www.R-project.org/posting-guide.html > ______________________________________________ [EMAIL PROTECTED] mailing list https://stat.ethz.ch/mailman/listinfo/r-help PLEASE do read the posting guide! http://www.R-project.org/posting-guide.html
