21 CFR Part 11 Compliance and R
Richard Haney wrote:
I have used S-PLUS, R, MATLAB and SAS for many years, and I am actually quite happy to use any of these four languages. The reason may in part involve my using the various languages for the purposes to which they seem most suited. Hence there are many things for which I would not use SAS or MATLAB, but for which I would greatly prefer to use R instead. On the other hand ( to take one of a couple of examples), in the past I have not even been permitted to use "R" whatsoever in clinical trials applications, which also typically involve a need for CFR Part 11 compliance. In this context, though, may I ask if there are people who have recently been able to use R for clinical trials work that is done within an FDA-approved 21 CFR Part 11-compliant framework?
Rich, Whoever told you that is not well-informed. CFR Part 11 has to do with critical software that runs medical devices and about certain primary data management software. It does not apply to statistical analysis software. We use R all the time in industry-sponsored and NIH sponsored clinical trials. You do not need to seek FDA's approval. FDA accepts all comers and does not dictate software policy for analysis. They even accept Excel and Minitab for NDAs. There are many messages related to this in the r-help archive; please look at them. Frank
Thanks very much. Rich Haney Richard.Haney at duke.edu Duke Comprehensive Cancer Center
Frank E Harrell Jr Professor and Chair School of Medicine
Department of Biostatistics Vanderbilt University