Gentlemen: Thankyou for your comments. I know I promised not to respond, but I just wanted to clarify something that Dieter mentioned below, not defend my remarks.
I understand "validate code" per 21 CFR part 11 complance to mean that for **ANY** code that is written, be it in SAS, R, VB, or whatever, that one must undertake a rigorous process to demonstrate that the code has been appropriately tested and documented, and that QC, history, traceability, and change control processes are in place, and so forth (as per the reg). My further understanding is that statistical "correctness" of the code is actually not (much of, anyway) an issue. What is important is that the documentation enables the code to be reproduced and used by other parties (e.g. reviewers) so that they can test "correctness" with whatever means they deem appropriate. So, again, as I understand it, there is no such thing as SAS, R, STATA, EXCEL or whatever code being a priori "validated" or not. The process must be undertaken for any corpus of code written in any language that is part of any FDA submission. So my point in my original remarks was only that to replace a body of already validated code in **any** language with a different body of code -- even in the SAME languaage-- is a time-consuming and costly effort. I hope this clarifies my remarks. Again, I appreciate the comments and would again appreciate even more others more knowledgeable in these issues correcting my misunderstandings or errors and adding further insight. Cheers to all, Bert Gunter Genentech Nonclinical Statistics -----Original Message----- From: r-help-boun...@r-project.org [mailto:r-help-boun...@r-project.org] On Behalf Of John Sorkin Sent: Friday, February 19, 2010 4:56 AM To: Dieter Menne; r-help@r-project.org Subject: Re: [R] Use of R in clinical trials Bert, There is a lesson here. Just as intolerance of any statistical analysis program (or system) other than SAS should lead to our being drive crazy, so to should intolerance of any statistical analysis program (or system) other than R. John >>> Dieter Menne <dieter.me...@menne-biomed.de> 2/19/2010 3:46 AM >>> Bert, I like your comments. There is one issue, however, that drives me crazy whenever I meet a customer asking "You are not using SAS? Too bad, we need validated results." Bert Gunter wrote: > > ... > Also to reiterate, it's not only > statistical/reporting functionality but even more the integration into the > existing clinical database systems that would have to be rewritten **and > validated**. > > Implicitly: Even if you let your cat enter SAS code, the results are correct, because they SAS is validated. Dieter -- View this message in context: http://n4.nabble.com/Use-of-R-in-clinical-trials-tp1559402p1561317.html Sent from the R help mailing list archive at Nabble.com. ______________________________________________ R-help@r-project.org 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. Confidentiality Statement: This email message, including any attachments, is for th...{{dropped:8}} ______________________________________________ R-help@r-project.org 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.
