Bert Gunter 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
For database software and for medical devices - > 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. What I would love to have is some efficiency estimates for SAS macro programming as done in pharma vs. using a high-level language. My bias is that SAS macro programming, which costs companies more than SAS licenses, is incredibly inefficient. Frank > > **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: r-help@stat.math.ethz.ch > 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 ______________________________________________ R-help@stat.math.ethz.ch 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.