Re: Orphan Drug

On 15 Mar 2006 19:46:24 GMT, Ian Stirling <root@xxxxxxxxxxxxxxxxx>
wrote:

GB <NotSomeone@xxxxxxxxxxxxx> wrote:

"Derek Potter" <me@xxxxxxxxxxx> wrote in message
news:emeg12p8n60q3v74qeertf0n5j10ciarip@xxxxxxxxxx
Only then would trials be done on healthy people, and then
under very close monitoring. The skimpy report you quoted makes it
sound like some mad scientist conned a thousand healthy volunteers
into drinking his untried evil potion and surprise, surprise, some of
them got ill.


The Times reported that there were 8 people in the trial altogether. 2 got a
placebo. The other 6 are all very seriously ill.

If anyone with a clue could comment.
It seems "obvious" to me that the first trial should happen with one
person, or at most two.
Is there a good reason to use 8?

http://www.newscientist.com/article/dn8852-new-drug-trial-puts-six-men-in-intensive-care.html
This was a "phase one trial" which follows animal testing. It was thus
extremely unlikely that there would be any severe effects.

I agree that a trial on one person would be ultra-cautious but I think
there are reasons why it isn't such a good idea. Using just one
subject means you will probably miss any problems that only affect say
1 in 4 people. So your cautious approach now requires a second trial
with 2 people, then 4 etc. Then you apply the same reasoning to
clinical trials, starting with say 5 patients and working slowly
towards several hundreds. By this time years have gone by. It's not
just commercial considerations either. Thousands of patients will die
because the drug hasn't been available.
.

Relevant Pages

  • Re: Orphan Drug
    ... The skimpy report you quoted makes it ... Is there a good reason to use 8? ... Thousands of patients will die ... when 8/8 atients have a severe reaction. ...
    (uk.legal)
  • Re: Orphan Drug
    ... The skimpy report you quoted makes it ... into drinking his untried evil potion and surprise, surprise, some of ... The other 6 are all very seriously ill. ... healthy volunteers, so my guess at the protocol was not quite correct. ...
    (uk.legal)
  • Re: Orphan Drug
    ... The skimpy report you quoted makes it ... into drinking his untried evil potion and surprise, surprise, some of ... The Times reported that there were 8 people in the trial altogether. ... The other 6 are all very seriously ill. ...
    (uk.legal)
  • Re: Orphan Drug
    ... The skimpy report you quoted makes it ... into drinking his untried evil potion and surprise, surprise, some of ... The other 6 are all very seriously ill. ...
    (uk.legal)