[R] Use of R in clinical trials

Peter Dalgaard p.dalgaard at biostat.ku.dk
Thu Feb 18 20:15:55 CET 2010

Christopher W. Ryan wrote:
> Pure Food and Drug Act: 1906
> FDA: 1930s
> founding of SAS: early 1970s
> (from the history websites of SAS and FDA)
> What did pharmaceutical companies use for data analysis before there was 
> SAS? And was there much angst over the change to SAS from whatever was 
> in use before?
> Or was there not such emphasis on and need for thorough data analysis 
> back then?

Well, I'm not quite old enough for this, but the story I heard is that 
before SAS was the desktop calculator, essentially. Statistics had 
correspondingly enormous focus on balanced designs, allowing computation 
to be reduced to means and sums of squares. This would typically be left 
to consulting firms employing (human) computers to literally do the 
sums. Digital computers had of course been around for decades at the 
time but mostly for hard core physics. (Well, actually, they were 
finding their way into accounting too.) So SAS was, I expect, pretty 
uniformly a relief.

At the same time, the requirements of the FDA have been tightening; I 
suppose partly due to technological feasibility, partly in response to 
certain practises being recognised as dubious, like selective 
publication, multiple testing, etc. And more data are required since new 
drugs are rarely all that much better than older ones, while the worries 
about side effects have increased.

> --Chris
> Christopher W. Ryan, MD
> SUNY Upstate Medical University Clinical Campus at Binghamton
> 425 Robinson Street, Binghamton, NY  13904
> cryanatbinghamtondotedu

    O__  ---- Peter Dalgaard             Øster Farimagsgade 5, Entr.B
   c/ /'_ --- Dept. of Biostatistics     PO Box 2099, 1014 Cph. K
  (*) \(*) -- University of Copenhagen   Denmark      Ph:  (+45) 35327918
~~~~~~~~~~ - (p.dalgaard at biostat.ku.dk)              FAX: (+45) 35327907

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