similar to: Using R for devices trial

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

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.

Following up to some extent on Friday's discussion regarding the 'validation' of R, could I ask the list group's opinion on possible advantages of R over Splus from a pharma/devices perspective? I wish to exclude the obvious price difference, which doesn’t seem to carry as much weight as I would have thought. Besides, I have noticed many former Splus users gravitating towards R,

I hope that Marc doesn't mind, but I felt that part of his recent post was important enough to deserve it's own subject line rather then being lost in a 60-msg-long thread... On Sun, Jan 11, 2009 at 10:08 AM, Marc Schwartz <marc_schwartz at comcast.net> wrote: ... I strongly believe that the comments regarding R and the FDA are overly negative and pessimistic. The hurdles to

Hi. After some time, my collegues at the Food and Drug Adminstration have finally acknowledged R as a powerful statistical computing environment. However, in order to comply with the Office of Information and Technology standards there are a couple of questions about whether R could interfere with other software. As I'm more of a driver of the R software and not a mechanic, I was hoping for

Hi. I have a problem that I can't seem to find an optimal way of solving other than by doing things manually. I'm trying to subset a data frame by the number of observations that occurred at a given row but want to take into account the number of observations of preceding rows. Here's an example. I'm looking at intervals of data [10,20), [10, 30), ....., [10,120) which contain a

The Intel compiled version also fails the below test: > ###------------ Very big and very small > umach <- unlist(.Machine)[paste("double.x", c("min","max"), sep='')] > xmin <- umach[1] > xmax <- umach[2] > tx <- unique(outer(-1:1,c(.1,1e-3,1e-7)))# 7 values (out of 9) > tx <- unique(sort(c(outer(umach,1+tx))))# 11 values

I am new to using R and would appreciate some advice on which books to start with to get up to speed on using R. My Background: 1-C# programmer. 2-Programmed directly using IMSL (Now Visual Numerics). 3- Used in past SPSS and Statistica. I put together a list but would like to pick the "best of" and avoid redundancy. Any suggestions on these books would be helpful (i.e. too much

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 am running R version 2.4.1 on Windows XP. I have a question regarding the datadist() function from the Design library. I have a data.frame (call it my.data) with 4 columns. When I submit the code datadist(data=my.data) I get the following error message: Error in X[[1]] : subscript out of bounds I suspect there may be something wrong with my data.frame (I'm certain there is nothing

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

Hi all, The survivals functions can be tested by the Log-rank test and others, for example the Gehan-Breslow. The graham breslow work with the alpha values. But I don't know how is the Gehan-Breslow test with R. Somebody know a type function?.. or other suggestions? Any help will be really appreciated Jos? Bustos Marine Biologist Master Apllied Stat Program University of Concepci?n

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/

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

I checked the help and the mailing list archives, but I can find no mention of a routine that calculates higher moments like skewness and kurtosis. Of course, these are easy enough to write myself, but I was thinking that they MUST be in here. Am I wrong? Thanks. -Frank

It appears that the maximum number of connections available in R is about 48. Can anyone tell me how to bump this number up? I've been perusing the source, but any info would speed things up. Is there a reason that it was set to such a low number? Thanks for any help. -Frank

Does anyone know of an R function for computing the Greenland-Robins variance for Mantel-Haenszel relative risks? Thanks Frank -- Frank E Harrell Jr Professor and Chair School of Medicine Department of Biostatistics Vanderbilt University

Hello. First: R 2.3.1 on Windows XP. I am trying to add information (sample size) to the Trellis strips which I am successful using the trellis.focus function with the default Windows device. However, I typically use the postscript device as I use LaTeX and \includegraphic for incorporating graphs into stat reviews. Here's some example code (apologies for the lack of creativity and

As I work as a biostatistician in the medical devices industry, I have been very happy to take part in several conversations on this list regarding the use of R in a regulated environment. It was with great interest, therefore, that I read the new guidance document for the use of R in regulated clinical trial environments now available on the R website. The purpose of the document is

Hello R-help, I need to compute matrices of first derivatives of a covariance matrix C with entries given by c_ij=theta*exp(-0.5* sum(eta*(x[i,]-x[j,])^2)), wrt to elements of eta, a m-dimensional vector of parameters, given a n*m data matrix x. So far, I have been computing matrices for each parameter (given by par[index]) analytically, using the following kmatder<- function(x, par, index) {