On Thu, 27 Nov 2003 07:48:02 +0100 "Antonia Drugica" <[EMAIL PROTECTED]> wrote:
> I'm quite new to this medical stuff. But my associates told me that we > are not free in choice of Statistical Software because the FDA has high > standards concerning this topic. But if they would prefer a specific > package (like SAS) that could mean, that this package vendourer could > lay back and hold it's hand open for licence money. Your associates are completely wrong. It is only sponsors that choose not to be free in their choice, due in my humble opinion mainly to the fact that SAS has been in use since 1966 and that "no one has ever been criticized by the FDA for using SAS." FDA even receives submissions based on Excel and we all know about the accuracy of Excel's statistical calculations. High standards need to be held by statisticians doing the analyses. Related to such standards open source systems such as R have many advantages, and the reproducible reporting capabilities of R using its Sweave package have major impacts on accuracy of reporting. I along with colleagues at another institution are working on an open source R package for clinical trial analysis and reporting that should be mature in about a year. I am currently using the package in two pharmaceutical industry-sponsored randomized clinical trials to report to data monitoring committees. I'm also working on a document addressing validation of statistical calculations. Let me know if you'd like a copy of the current version of that document. > > Is there any part of the ICH document referring to software packages? I > really would use R for some tasks but therefor I need arguments... Don't know of anything in ICH. In view of the fact that large pharma companies have to pay more than $10M per year in SAS licenses and have to hire armies of non-intellectually challenged SAS programmers to do the work of significantly fewer programmers that use modern statistical computing tools like R and S-Plus, it is surprising that SAS is still the most commonly used tool in the clinical side of drug development. I quit using SAS in 1991 because my productivity jumped at least 20% within one month of using S-Plus. --- Frank E Harrell Jr Professor and Chair School of Medicine Department of Biostatistics Vanderbilt University ______________________________________________ [EMAIL PROTECTED] mailing list https://www.stat.math.ethz.ch/mailman/listinfo/r-help