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I have worked on clinical trials in FDA submissions for many years. I use SAS almost exclusively. Recently I discussed a consulting job I had to bootstrap a Deming regression. Bootstrapping is much more easily done in R I think and several experts have suggested ways that I can do this in R. Since this is going into a resubmission to the FDA for my client I am concerned as to whether software validation might become an issue. I hear that R is gaining acceptance with the FDA and experts tell me that traceability which is an attractive feature with SAS can be dealt with easily in R as well.

My client did the original Deming regression with a package that I am not familiar with and validation was not an issue with the original submission. I want to help without adding any new headaches for them.

Can the R experts here give me some guidance? If it will help I can mention some of the programming options that were suggested?

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    $\begingroup$ Not a direct answer, but re bootstrapping in SAS, do you know of David Cassell's paper "Don't be Loopy"? $\endgroup$
    – Peter Flom
    Oct 3, 2012 at 12:28
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    $\begingroup$ This is a bit open ended, and I'm not sure what you expect to hear that hasn't already been said in other questions, R vs SAS, why is SAS prefered by private companies? and Is the R language reliable for the field of economics?. In particular, the comments on your answer to the SAS v R question seem sufficient to answer this (especially the Revo R blog post cited). $\endgroup$
    – Andy W
    Oct 3, 2012 at 13:11
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    $\begingroup$ r-project.org/doc/R-FDA.pdf might be useful. $\endgroup$
    – Laurent
    Oct 3, 2012 at 13:31
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    $\begingroup$ Thanks for all the comments thus far. I will check out all the links! @PeterFlom I don't know that paper. Does it have something to do with whether or not to imbed one procedure in another? Anyway I would be curious to see it. Can you provide a link? Personally I think the bootstrap has a useful role to play in comparing models as in variable selection in logistic regression that Gail Gong studied in the 1980s. I think it can be another way of doing sensitivity analysis $\endgroup$
    – Michael R. Chernick
    Oct 3, 2012 at 16:23
  • $\begingroup$ Hi @MichaelChernick don't be loopy $\endgroup$
    – Peter Flom
    Oct 3, 2012 at 16:26

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We have done tons of submission to the FDA with R. The Agency do not prefer a software versus the other.

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