Bert, I just want to make sure what I said is not overstated to offend statistician who use SAS. actually, i am using SAS daily and able to use it pretty well. ^_^ What I meant are: 1) I don't understand the mentality 2) using SAS instead of R might be related to job-security. which is very different from "their mentality is related to job security".
On 6/8/07, Bert Gunter <[EMAIL PROTECTED]> wrote: > Frank et. al: > > I believe this is a bit too facile. 21 CFR Part 11 does necessitate a > software validation **process** -- but this process does not require any > particular software. Rather, it requires that those using whatever software > demonstrate to the FDA's satisfaction that the software does what it's > supposed to do appropriately. This includes a lot more than assuring, say, > the numerical accuracy of computations; I think it also requires > demonstration that the data are "secure," that it is properly transferred > from one source to another, etc. I assume that the statistical validation of > R would be relatively simple, as R already has an extensive test suite, and > it would simply be a matter of providing that test suite info. A bit more > might be required, but I don't think it's such a big deal. > > I think Wensui Liu's characterization of clinical statisticians as having a > mentality "related to job security" is a canard. Although I work in > nonclinical, my observation is that clinical statistics is complex and > difficult, not only because of many challenging statistical issues, but also > because of the labyrinthian complexities of the regulated and extremely > costly environment in which they work. It is certainly a job that I could > not do. > > That said, probably the greatest obstacle to change from SAS is neither > obstinacy nor ignorance, but rather inertia: pharmaceutical companies have > over the decades made a huge investment in SAS infrastructure to support the > collection, organization, analysis, and submission of data for clinical > trials. To convert this to anything else would be a herculean task involving > huge expense, risk, and resources. R, S-Plus (and much else -- e.g. numerous > "unvalidated" data mining software packages) are routinely used by clinical > statisticians to better understand their data and for "exploratory" analyses > that are used to supplement official analyses (e.g. for trying to justify > collection of tissue samples or a pivotal study in a patient subpopulation). > But it is difficult for me to see how one could make a business case to > change clinical trial analysis software infrastructure from SAS to S-Plus, > SPSS, or anything else. > > **DISCLAINMER** > My opinions only. They do not in any way represent the view of my company or > its employees. > > > Bert Gunter > Genentech Nonclinical Statistics > South San Francisco, CA 94404 > 650-467-7374 > > > -----Original Message----- > From: [EMAIL PROTECTED] > [mailto:[EMAIL PROTECTED] On Behalf Of Frank E Harrell Jr > Sent: Friday, June 08, 2007 7:45 AM > To: Giovanni Parrinello > Cc: [email protected] > Subject: Re: [R] "R is not a validated software package.." > > Giovanni Parrinello wrote: > > Dear All, > > discussing with a statistician of a pharmaceutical company I received > > this answer about the statistical package that I have planned to use: > > > > As R is not a validated software package, we would like to ask if it > > would rather be possible for you to use SAS, SPSS or another approved > > statistical software system. > > > > Could someone suggest me a 'polite' answer? > > TIA > > Giovanni > > > > Search the archives and you'll find a LOT of responses. > > Briefly, in my view there are no requirements, just some pharma > companies that think there are. FDA is required to accepted all > submissions, and they get some where only Excel was used, or Minitab, > and lots more. There is a session on this at the upcoming R > International Users Meeting in Iowa in August. The session will include > dicussions of federal regulation compliance for R, for those users who > feel that such compliance is actually needed. > > Frank > > -- > Frank E Harrell Jr Professor and Chair School of Medicine > Department of Biostatistics Vanderbilt University > > ______________________________________________ > [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 > and provide commented, minimal, self-contained, reproducible code. > > ______________________________________________ > [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 > and provide commented, minimal, self-contained, reproducible code. > -- WenSui Liu A lousy statistician who happens to know a little programming (http://spaces.msn.com/statcompute/blog) ______________________________________________ [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 and provide commented, minimal, self-contained, reproducible code.
