[Rd] NY Times article

Nicholas Lewin-Koh nikko at hailmail.net
Sat Jan 10 20:19:39 CET 2009


Hi,
Unfortunately one of the the cornerstones of the validation paradigm
in the clinical world (as I understand it) is that
consistency/repeatability,
documentation (of the programs consistency and maintenance) and
adherence to regulatory
requirements take supremacy even ironically over correctness. So you
still
get ridiculous requirements from regulatory bodies like type III sums of
squares, Last observation carried forward, etc. These edifices are
very hard to change, I know of people who have worked their whole
careers just to get the FDA to allow other treatment of missing data.

So what does this have to do with R? This comes down to the point
you made below about the R development cycle incorporating bug fixes
into new releases, and not supporting old versions. I think this has 
been rehashed many times, and is not likely to change. So how to
move R into the clinic? From a practical perspective all the
development and interoperability features of R are very nice,
but how to maintain things in a way that if the underlying
R platform changes the tool or method does not, and furthermore 
how to manage this in a cost effective way so that it can't
be argued that it is cheaper to pay for SAS???

These are not necessarily questions that R core has to answer,
as the burden of proof of validation is really in the hands of the 
company/organization doing the submission. We just like to pretend that
the large price we pay for our SAS support means we can shift liability
:)

Rambling again,
Nicholas


On Fri, 09 Jan 2009 17:07:31 -0600, "Kevin R. Coombes"
<krcoombes at mdacc.tmc.edu> said:
> Hi Nicholas,
> 
> You raise a very good point. As an R user (who develops a couple of 
> packages for our own local use), I sometimes find myself cringing in 
> anticipation of a new R (or BioConductor) release. In my perception 
> (which is almost certainly exaggerated, but that's why I emphasize that 
> it is only an opinion), clever theoretical arguments in favor of 
> structural changes have a tendency to outweigh practical considerations 
> of backwards compatibility.
> 
> One of my own interests is in "reproducible research", and I've been 
> pushing hard here at M.D. Anderson to get people to use Sweave to 
> enhance the reproducibility of their own analyses. But, more often than 
> I would like, I find that reports written in Sweave do not survive the 
> transition from one version of R to the next, because either the core 
> implementation or one of the packages they depend on has changed in some 
> small but meaningful way.
> 
> For our own packages, we have been adding extensive regression testing 
> to ensure that the same numbers come out of various computations, in 
> order to see the effects of either the changes that we make or the 
> changes in the packages we depend on.  But doing this in a nontrivial 
> way with real data leads to test suites that take a long time to run, 
> and so cannot be incorporated in the nightly builds used by CRAN.
> 
> We also encourage our analysts to include a "sessionInfo()" command in 
> an appendix to each report so we are certain to document what versions 
> of packages were used.
> 
> I suspect that the sort of validation you want will have to rely on an 
> extensive regression suite test to make certain that the things you need 
> remain stable from one release to another. That, and you'll have to be 
> slow about upgrading (which may mean foregoing support from the mailing 
> lists, where a common refrain in response to bug reports is that "you 
> aren't using the latest and greatest version", without an appreciation 
> of the fact that there can be good reasons for not changing something 
> that you know works....).
> 
> Best,
> 	Kevin
> 
> Nicholas Lewin-Koh wrote:
> > Hi,
> > Kudos, nice exposure, but to make this more appropriate to R-devel I
> > would just
> > like to make a small comment about the point made by the SAS executive
> > about getting
> > on an airplane yada yada ...
> > 
> > 1) It would seem to me that R has certification documents
> > 2) anyone designing airplanes, analyzing clinical trials, etc. had 
> >    better be worried about a lot more than whether their software is
> >    proprietary.
> > 
> > So from that point of view it would seem that R has made great strides
> > over 
> > the last 5 years especially in establishing a role for open source
> > software solutions in regulated/ commercial
> > environments. The question now is how to meld the archiac notions of
> > validation and 
> > and verification seen in industry with the very different model of open
> > source
> > development? Rather than the correctness of the software, in which I
> > think R is competitive,
> > it is how to deal with the rapid release cycles of R, and the
> > contributed packages.
> > We pull our hair out in pharma trying to figure out how we would ever
> > reconcile CRAN and validation requirements. I have no brilliant
> > soulution,
> > just food for thought
> > 
> > Nicholas
> >  ------------------------------
> >> Message: 5
> >> Date: Thu, 8 Jan 2009 13:02:55 +0000 (GMT)
> >> From: Prof Brian Ripley <ripley at stats.ox.ac.uk>
> >> Subject:Re: [Rd]  NY Times article
> >> To: Anand Patil <anand.prabhakar.patil at gmail.com>
> >> Cc: r-devel at r-project.org
> >> Message-ID: <alpine.LFD.2.00.0901081258470.5529 at auk.stats.ox.ac.uk>
> >> Content-Type: TEXT/PLAIN; charset=US-ASCII; format=flowed
> >>
> >> It has been all over R-help, in several threads.
> >>
> >> https://stat.ethz.ch/pipermail/r-help/2009-January/184119.html
> >> https://stat.ethz.ch/pipermail/r-help/2009-January/184170.html
> >> https://stat.ethz.ch/pipermail/r-help/2009-January/184209.html
> >> https://stat.ethz.ch/pipermail/r-help/2009-January/184232.html
> >> https://stat.ethz.ch/pipermail/r-help/2009-January/184237.html
> >>
> >> and more
> >>
> >> On Thu, 8 Jan 2009, Anand Patil wrote:
> >>
> >>> 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]]
> >>>
> >>> ______________________________________________
> >>> R-devel at r-project.org mailing list
> >>> https://stat.ethz.ch/mailman/listinfo/r-devel
> >>>
> >> -- 
> >> Brian D. Ripley,                  ripley at stats.ox.ac.uk
> >> Professor of Applied Statistics,  http://www.stats.ox.ac.uk/~ripley/
> >> University of Oxford,             Tel:  +44 1865 272861 (self)
> >> 1 South Parks Road,                     +44 1865 272866 (PA)
> >> Oxford OX1 3TG, UK                Fax:  +44 1865 272595
> >>
> > 
> > ______________________________________________
> > R-devel at r-project.org mailing list
> > https://stat.ethz.ch/mailman/listinfo/r-devel



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