I apologize for adding this so late to the "SAS or R software " thread. This is a question, not a reply, but it seems to me to fit in well with the subject of this thread.
I would like to know anyone's experiences in the following two areas below. I should add I have no experience myself in these areas:
1) Migrating from SAS to R in the choice of statistical software used for FDA reporting.
(For example, was there more effort involved in areas of documentation, revision tracking, or validation of software codes?)
This brings up a question that I have often asked but have never had answered. If someone asks me if R is "validated" I usually respond "by whom and for what?". There seems to be an belief that the FDA validates software as acceptable for use in the analysis of data for a submission to the FDA. However I have never met anyone who can describe to me exactly what this entails. So I can't say if R is "validated" because I don't know what that means.
As I understand it the FDA does not certify or validate software as providing "correct" or acceptable answers. I have been told that what the FDA requires is that the software used to produce the results quoted in a submission should be auditable. That is, the FDA must be able to check exactly how the numerical results were produced, should they wish to do so. This can be tricky for proprietary software because typically the group making the submission does not have access to the source code so there has to be a delicate three-way negotiation on the extent to which the software vendor will reveal their source code. However, revealing source code not a difficult issue in the open source world. Representatives of the FDA (or anyone else, for that matter) can read the source code any time they want to. In fact they are encouraged to do so.
So if the standard is "auditable" I don't think you get much more auditable than R is.
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