Re: Blinded studies
- From: "franco" <franco@xxxxxxxx>
- Date: 18 Mar 2007 11:02:21 -0700
On 18 mrt, 05:35, Richard Ulrich <Rich.Ulr...@xxxxxxxxxxx> wrote:
I think that safety monitoring of side effects is done by
an independent committee that is not blind. This is very
easy if the side effect is such that the subject is being
dropped because of the side effect.
It depends on what your 'safety' problem is, but in many
instances, complete diagnosis and treatment of the side-effect
will depend on knowing the actual intervention. For instance,
you do *not* have a toxic reaction to the treatment medication
if the assigned medication was a placebo.
Yes I understand, but what I'm proposing is that one is (the
investigator), for the known reasons in clinical studies, blinded from
knowing which subject got which treatment. Say that there happens to
be some specific symptom onset in the study with a rate of 30%. Though
it might be in either the placebo or the treatment, one can still
detect that there is something wrong if one compares those 30% with
either the the normal background or with the results of previous
matched clinical trials where the rate average is, say, 12%. Or are
all safety monitoring done by independent committees who have all the
unblinded data?
.
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- Blinded studies
- From: franco
- Re: Blinded studies
- From: Richard Ulrich
- Blinded studies
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