The fact that FDA statisticians are using R also assuages one of the main
concerns that I have heard voiced about using R for FDA submissions - that
there would be no statisticians available at FDA to review R code which
would seriously delay the review of a submission.
Mark also brings up a good point by mentioning the FDA guidance on Bayesian
submissions. If SAS were the only approved product, Bayesian trials would
be in real trouble.
Cody Hamilton, PhD
Staff Biostatistician
Edwards Lifesciences
Disclaimer: As always, I am speaking for myself and not necessarily for
Edwards lifesciences.
One closing comment: There is increasing use of R within the FDA itself
and this will only further help to assuage the fears of prospective
users over time.
Best regards,
Marc Schwartz
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