I like R more than SAS. My job is doing research on clinical trial. But I was told that FDA only accepts the result from SAS. Is that true? TOO BAD. [[alternate HTML version deleted]]
"wensui liu" <liuwensui at hotmail.com> writes:> I like R more than SAS. My job is doing research on clinical > trial. But I was told that FDA only accepts the result from SAS. Is > that true? TOO BAD.No. But it's not that simple. See previous postings (within the last 2 months) on validation and FDA. best, -tony -- A.J. Rossini / rossini at u.washington.edu / rossini at scharp.org Biomedical/Health Informatics and Biostatistics, University of Washington. Biostatistics, HVTN/SCHARP, Fred Hutchinson Cancer Research Center. FHCRC: 206-667-7025 (fax=4812)|Voicemail is pretty sketchy/use Email CONFIDENTIALITY NOTICE: This e-mail message and any attachments ... {{dropped}}
>-----Original Message----- >From: r-help-bounces at stat.math.ethz.ch >[mailto:r-help-bounces at stat.math.ethz.ch] On Behalf Of wensui liu >Sent: Friday, June 06, 2003 1:16 PM >To: r-help at stat.math.ethz.ch >Subject: [R] sas vs. r > > >I like R more than SAS. My job is doing research on clinical >trial. But I was told that FDA only accepts the result from >SAS. Is that true? TOO BAD.See these recent posts by Frank Harrell: http://maths.newcastle.edu.au/~rking/R/help/03a/4210.html http://maths.newcastle.edu.au/~rking/R/help/03a/4231.html http://maths.newcastle.edu.au/~rking/R/help/03a/4246.html HTH, Marc Schwartz
Please check "http://www.r-project.org/" -> search -> "R site search". My search just now for "R vs. SAS for FDA" produced 14 matches. My bottom line from reading comments on this issue is that it is like the comment 20 years ago that, "Nobody in management ever got fired for buying IBM." The "r-help" archives include comments that FDA has no specific guidelines for what software must be used, although there are doubtless general guidelines relating to documentation and testing that it does what it claims. hth. spencer graves wensui liu wrote:> I like R more than SAS. My job is doing research on clinical trial. But I was told that FDA only accepts the result from SAS. Is that true? TOO BAD. > > > > [[alternate HTML version deleted]] > > ______________________________________________ > R-help at stat.math.ethz.ch mailing list > https://www.stat.math.ethz.ch/mailman/listinfo/r-help
On Fri, 6 Jun 2003, wensui liu wrote:> I like R more than SAS. My job is doing research on clinical trial. But > I was told that FDA only accepts the result from SAS. Is that true? TOO > BAD. >No, it isn't true. The FDA does not approve or certify statistical software. Its main regulation relevant to statistical analysis is in 21 CFR 11, and is largely about audit trails. In fact the FDA is very reluctant to issue blanket approval or disapproval for anything -- it likes to keep its options open. On the other hand, if a company has been successful in getting FDA approval with analyses done one way, there is a substantial incentive not to change. Why take the risk that it might slow down the approval of your application? -thomas