similar to: Use of R in clinical trials

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

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

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

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/

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

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

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

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]]

Hi All I am really very interested in starting to use R within our company. I particularly like the open source nature of the product. My company is a medical research company which is part of the University of London. We conduct contract virology research for large pharma companies. My question is how do we validate this software? I wonder if anyone else has had the problem and might be able to

I like R more than SAS. My job is doing research on clinical trial. But I was told that FDA only accepts the result from SAS. Is that true? TOO BAD. [[alternate HTML version deleted]]

The Quantitative Decision Strategies group at Janssen Research & Development, Johnson & Johnson, is looking for a candidate to represent QDS in Beijing, China in the subsidiary company of Xian-Janssen Pharmacetical Ltd. The basic requirements for this candidate are 1) 3+ years experience in a quantitative field, but not necessarily pharmaceutical; 2) PhD in statistics or related field

I used both BMDP and SAS in my earlier years, side by side. At that time the BMDP statistical methods were much more mature and comprehensive: we treated them as the standard when the two packages disagreed. (It was a BMDP manual that clearly explained to me what the hypothesis of "Yate's weighted mean test" is, something SAS decided to call "type III" and eternally

Sorry if this is spam, but I couldn't see it having popped up on the list yet. http://www.nytimes.com/2009/01/07/technology/business-computing/07program.html?emc=eta1 Anand [[alternative HTML version deleted]]

Is anybody using R to do analysis of clinical trial datasets that have been put in the public domain (which are super hard to find). Not only a single data table, but the actual database, with a handful of data tables with one-to-one or many-to-one relationships? [ For example, "Adverse Events" and "Patient Info" are two datasets with a many-to-one relationship, the

Hi, I have a series of id's with multiple visits and questionnaire scores. This is a clinical trial that will be analyzed using the last observation carried forward method. In other words, in order to comply with intent to treat analysis when many subjects withdraw, data points for the last visit must be generated and filled in with the last observation. The ultimate goal is to tabulate 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

A colleague pointed out that the United States Food and Drug Administration (FDA) has adopted a transport format defined by SAS Institute as a standard for electronic submissions of data. As a result, this format has been openly documented. The URL for the documentation on the format is http://ftp.sas.com/techsup/download/technote/ts140.html Information on the FDA standards for

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,