similar to: R, clinical trials and the FDA

Yesterday I just noticed the new document on R and regulatory aspects for biomedical research posted at http://www.r-project.org/doc/R-FDA.pdf Coming from an institution that performs a large number of clinical trials for FDA and being an advocate of R myself, I have found that the following issues usually come up when discussing the use of R for FDA trials: 1. Most FDA submissions come down to

Dear All, discussing with a statistician of a pharmaceutical company I received this answer about the statistical package that I have planned to use: As R is not a validated software package, we would like to ask if it would rather be possible for you to use SAS, SPSS or another approved statistical software system. Could someone suggest me a 'polite' answer? TIA Giovanni -- dr.

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

Hello Everyone,   I’m a SAS user who has recently become interested in sequential clinical trials designs. I’ve discovered that the SAS based approaches for these designs are either too costly or are “experimental.” So now I’m looking for alternative software. Two programs that seem promising are SPLUS Seqtrial and R.   I recently obtained a 30 day trial for the SPLUS Seqtrial add-on and have

Dear all, There have been a variety of discussions on the R list regarding the use of R in clinical trials. The following post from the STATA list provides an interesting opinion regarding why SAS remains so popular in this arena: http://www.stata.com/statalist/archive/2008-01/msg00098.html Regards, -Cody Hamilton

Does anybody know if R is FDA or ICH (or EMEA...) compliant? AFAIK S-Plus is but that means nothing... -- Trebate bolji pristup internetu? Nazovite IskonInternet na 0800 1000 ili pogledajte http://www.iskon.biz/individualni/usluge/dialup/

Full_Name: David D Degras Version: 2.8.0 OS: Mac OS X Submission from: (NULL) (128.135.239.11) I have recently installed the version 2.8.0 of R along with package fda (v 2.0.2) and its dependencies (including package splines v. 2.8.0). Here are my problems: 1) The package splines should feature functions such a predict.bs, predict.bSpline and such and it does not! I can make calls to bs, ns,

Dear friends - I am trying to understand fda and working with the 2009 book from Springer. I run the scripts directly from a new installed fda library and include sessionInfo() below. This is from the script fdarm-ch09.R - I seem to have got not fda_2.2.8 but 2.2.7 - is that the problem? Where do I get .8 as I just reinstalled? Best wishes Troels Ring, Nephrology Aalborg, Denmark >

Dear All, I will soon be working with NIH and possibly FDA. Will I be able to use R or will I be forced to use SAS? Cheers, Federico -- Federico C. F. Calboli Department of Epidemiology and Public Health Imperial College, St. Mary's Campus Norfolk Place, London W2 1PG Tel +44 (0)20 75941602 Fax +44 (0)20 75943193 f.calboli [.a.t] imperial.ac.uk f.calboli [.a.t] gmail.com

Dear friends - We have 25 rats, 14 of these subjected to partial removal of kidney tissue, 11 to sham operation, and then followed for 6 weeks. So far we have data on 26 urine metabolites measured by NMR 7 times during the observation. I have smoothed the measurements by b.splines in fda including a roughness penalty, and inspecting the mean curves for nephrectomized and sham animals indicate

Does anyone know if for clinical studies the FDA would accept statistical analyses performed with R ? Delphine Fontaine

Hi all there Can some one clarify me on this issue, features wise which is better R or SAS, leaving the commerical aspect associated with it. I suppose there are few people who have worked on both R and SAS and wish they would be able to help me in deciding on this. THank you for the help --------------------------------- [[alternative HTML version deleted]]

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

Dear All, I am fairly new to R. I work mainly in SAS. Now, I know that SAS is approved by the FDA for submissions. My question is, does the FDA approve {R} for clinical trial submissions. Also has anyone ever tried to produce TFL's using R. I would like to know how difficult it to produce the TFL's in R as compared to SAS. I know that in SAS it is not difficult once you know

fda 1.2.3 ======================== Version 1.2.3 of the fda package has just been released. This version adds to previous versions a script to create most of the figures of chapter 6 of "Applied Functional Data Analysis" by Ramsay and Silverman. Other changes offer simpler calls to time warping / registration and functional principal component functions. The fda package supports the

Dear R-Helpers, Apologies in advance as this is partly (widely ?) OT. Not sure where to ask, R is my favorite computer tool (no kidding) and there are plenty of knowledgable and helpful people on the list. Background: There are discussions among experts and regulatory authorities (cf guideline http://www.emea.europa.eu/pdfs/human/ewp/056598en.pdf) that, in for example Amyotrophic Lateral

Dear All, I am looking an R version of the "Computer program for sample size and power calculations in the design of multi-arm and factorial clinical trials with survival endpoints". Best regards, Giovanni Parrinello P.S.: in the meantime I am preparing a summary for my preceeding question about time-varying covariates in the Cox model and I thank Frank Harrell, Chuck Cleland,

Hi all, I am setting up a new AD server with Samba 4.1.11 from the FreeBSD ports. I struggle with the internal DNS. I add a new CNAME record but it does not show up properly. I gave the AD domain a new DNS domain (domain.fda) and the server the name samba4.domain.fda. I am using the internal DNS, and a forwarder to a bind server in the same network. After the AD provision I have this here

The fda package supports "Functional Data Analysis" and "Applied Functional Data Analysis" by Bernard Silverman and James Ramsay. Functional data analysis, which lots of us like to call "FDA", is about the analysis of information on curves or functions. FDA is a collection statistical techniques for answering questions like, "What are the main ways in which the

The fda package supports "Functional Data Analysis" and "Applied Functional Data Analysis" by Bernard Silverman and James Ramsay. Functional data analysis, which lots of us like to call "FDA", is about the analysis of information on curves or functions. FDA is a collection statistical techniques for answering questions like, "What are the main ways in which the