Sicotte, Hugues Ph.D. wrote: > People, don't get angry at the pharma statistician, he is just trying to > abide by an FDA requirement that is designed to insure that test perform > reliably the same. There is no point in getting into which product is > better. As far as the FDA rules are concerned a validated system beats a > "better" system any day of the week.
There is no such requirement. > > Here is your polite answer. > You can develop and try your software in R. > Should they need to use those results in a report that will matter to > the FDA, then you can work together with him to set up a validated > environment for S-plus. You then have to commit to port your code to > S-plus. That doesn't follow. What matters is good statistical analysis practice no matter which environment you use. Note that more errors are made in the data preparation / derived variables stage than are made by statistical software. Frank > > As I assume that you do not work in a regulated environment, you > probably wouldn't have access to a validated SAS environment anyways. It > is not usually enough to install a piece of software, you have to > validate every step of the installation. Since AFAIK the FDA uses > S-plus, it would be to your pharma person's advantage to speed-up > submissions if they also had a validated S-plus environment. > > http://www.msmiami.com/custom/downloads/S-PLUSValidationdatasheet_Final. > pdf > > > -----Original Message----- > From: [EMAIL PROTECTED] > [mailto:[EMAIL PROTECTED] On Behalf Of Wensui Liu > Sent: Friday, June 08, 2007 9:24 AM > To: Giovanni Parrinello > Cc: r-help@stat.math.ethz.ch > Subject: Re: [R] "R is not a validated software package.." > > I like to know the answer as well. > To be honest, I really have hard time to understand the mentality of > clinical trial guys and rather believe it is something related to job > security. > > On 6/8/07, Giovanni Parrinello <[EMAIL PROTECTED]> 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 >> >> -- >> dr. Giovanni Parrinello >> External Lecturer >> Medical Statistics Unit >> Department of Biomedical Sciences >> Viale Europa, 11 - 25123 Brescia Italy >> Tel: +390303717528 >> Fax: +390303717488 >> email: [EMAIL PROTECTED] >> >> >> [[alternative HTML version deleted]] >> >> ______________________________________________ >> 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. >> > > -- 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.