I would like to use R for submissions to FDA/CDRH (the medical device company I work for currently uses only SAS). Previous postings to the list regarding R and 21 CFR 11 compliance have been very helpful. However, reluctance to using open source software for statistical analyses and reporting remains high here at my company. Has anyone used R for an official submission to FDA/CDRH? It would be most helpful if I could tell our group that others have been able to use R for this purpose. Regards, Cody Hamilton Staff Biostatistician Edwards Lifesciences
Hi Cody, I would point you to the presentation by Sue Bell at least year's ASA meeting available here: http://www.fda.gov/Cder/Offices/Biostatistics/Bell.pdf. I can't speak for CDRH, but at CDER we are making some progress towards the level of comfort with the use of R as a "valid" software tool. Specifically, 1. R was granted approval by our IT folks for use on our government PC's (2 years in the making to get this). 2. An R course is in development for FDA reviewers to use R for review of clinical trial data. 3. This Monday at the 1st FDA/DIA Spring Meeting I will be offering a tutorial on Statistical Graphics with R for Clinical Trial Data. 4. An increasing effort to pigeon-tail R to ongoing projects to show proof by example that R can be trusted when used properly. So from the regulatory side, progress is being made, but there still do exist those who have some discomfort with the use of an open-source tool for data analysis. Someday hopefully that too will be changed. HTH, -Mat Disclaimer: The views expressed are those of the author and must not be taken to represent policy or guidance on behalf of the Food and Drug Administration. -----Original Message----- From: r-help-bounces at stat.math.ethz.ch [mailto:r-help-bounces at stat.math.ethz.ch] On Behalf Of Cody_Hamilton at edwards.com Sent: Thursday, March 01, 2007 5:43 PM To: r-help at r-project.org Subject: [R] Using R for devices trial I would like to use R for submissions to FDA/CDRH (the medical device company I work for currently uses only SAS). Previous postings to the list regarding R and 21 CFR 11 compliance have been very helpful. However, reluctance to using open source software for statistical analyses and reporting remains high here at my company. Has anyone used R for an official submission to FDA/CDRH? It would be most helpful if I could tell our group that others have been able to use R for this purpose. Regards, Cody Hamilton Staff Biostatistician Edwards Lifesciences ______________________________________________ R-help at stat.math.ethz.ch mailing list https://stat.ethz.ch/mailman/listinfo/r-help PLEASE do read the posting guide http://www.R-project.org/posting-guide.html and provide commented, minimal, self-contained, reproducible code.
Mat,
Thank you for the update and for the link. I look forward to (hopefully)
using R for future FDA submissions.
Regards,
-Cody
"Soukup, Mat"
<Mat.Soukup at fda.h
hs.gov> To
Cody_Hamilton at edwards.com,
03/02/2007 05:28 r-help at r-project.org
AM cc
Subject
RE: [R] Using R for devices trial
Hi Cody,
I would point you to the presentation by Sue Bell at least year's ASA
meeting available here:
http://www.fda.gov/Cder/Offices/Biostatistics/Bell.pdf. I can't speak
for CDRH, but at CDER we are making some progress towards the level of
comfort with the use of R as a "valid" software tool. Specifically,
1. R was granted approval by our IT folks for use on our government PC's
(2 years in the making to get this).
2. An R course is in development for FDA reviewers to use R for review
of clinical trial data.
3. This Monday at the 1st FDA/DIA Spring Meeting I will be offering a
tutorial on Statistical Graphics with R for Clinical Trial Data.
4. An increasing effort to pigeon-tail R to ongoing projects to show
proof by example that R can be trusted when used properly.
So from the regulatory side, progress is being made, but there still do
exist those who have some discomfort with the use of an open-source tool
for data analysis. Someday hopefully that too will be changed.
HTH,
-Mat
Disclaimer: The views expressed are those of the author and must not be
taken to represent policy or guidance on behalf of the Food and Drug
Administration.
-----Original Message-----
From: r-help-bounces at stat.math.ethz.ch
[mailto:r-help-bounces at stat.math.ethz.ch] On Behalf Of
Cody_Hamilton at edwards.com
Sent: Thursday, March 01, 2007 5:43 PM
To: r-help at r-project.org
Subject: [R] Using R for devices trial
I would like to use R for submissions to FDA/CDRH (the medical device
company I work for currently uses only SAS). Previous postings to the
list
regarding R and 21 CFR 11 compliance have been very helpful. However,
reluctance to using open source software for statistical analyses and
reporting remains high here at my company. Has anyone used R for an
official submission to FDA/CDRH? It would be most helpful if I could
tell
our group that others have been able to use R for this purpose.
Regards,
Cody Hamilton
Staff Biostatistician
Edwards Lifesciences
______________________________________________
R-help at stat.math.ethz.ch mailing list
https://stat.ethz.ch/mailman/listinfo/r-help
PLEASE do read the posting guide
http://www.R-project.org/posting-guide.html
and provide commented, minimal, self-contained, reproducible code.