[R] OT: Is randomization for targeted cancer therapies ethical?

[Charles C. Berry]

On Mon, 20 Sep 2010, Bert Gunter wrote:

> Hi Folks:
>
> **Off Topic**
>
> Those interested in clinical trials may find the following of interest:
>
> http://www.nytimes.com/2010/09/19/health/research/19trial.html
>
> It concerns the ethicality of randomizing those with life-threatening
> disease to relatively ineffective SOC when new "biologically targeted"
> therapies "appear" to be more effective. While the context may be new,
> the debate, itself, is not: Tukey wrote (or maybe it was talked -- I
> can't remember for sure) about this about 30 years ago. I'm sure many
> other also have done so.

Anscombe's remarkable (and influential) review of Armitage's 'Sequential 
Medical Trials' back in 1963

 	http://www.jstor.org/stable/2283272

is worth a look by any statistician who is interested in this topic.

It makes explicit several factors that weigh in the ethical assessment of 
a particular trial design.

He discusses in formal terms the weighing of outcomes for patients 
in the trial at hand aginst those of future patients and the impact that 
this might have on design decisions.

HTH,

Chuck


>
> Cheers,
>
> Bert
> -- 
> Bert Gunter
> Genentech Nonclinical Biostatistics
>
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Charles C. Berry                            (858) 534-2098
                                             Dept of Family/Preventive Medicine
E mailto:cberry at tajo.ucsd.edu	            UC San Diego
http://famprevmed.ucsd.edu/faculty/cberry/  La Jolla, San Diego 92093-0901