I am confused by this discussion and wonder if two different issues
are being discussed here.
The uncertainty principle, it seems to me, is what should be
order to determine whether a study should be undertaken at all. Do
if drug A is definitely better than placebo? If we don't know the
that, then and only then, is a study ethical.
Firstly Jeanne seems to be talking about the determination of
whether a trial protocol is ethical or not. This is governed by the ethical
principle of equipoise, or level of collective uncertainty about the
efficacy/effectiveness of a treatment.
However, once we determine
that we are uncertain and a study is ethical - to allow clinicians
patients from randomization still seems to be risky to me and I
that undermining the study's genuine randomness.
Secondly are not random selection and random allocation being
confused here? The example Jeanne initially used seemed to involve selection
prior to randomisation. I interpret the issue Jeanne is concerned about is
the influence inclusion/exlusion criteria may have on the trial's
generalizability, and this seems to get at the substantive ethics of RCTs
i.e. whether this trial design is addressing a societally desired/needed
issue. The application of inclusion/exclusion criteria gets to the heart of
the purpose of the trial - whether it is explanatory or pragmatic; if
explanatory then stricter inclusion criteria may be appropriate, but it may
be argued that a pragmatic design (i.e. one that is more open in its
inclusion criteria) is what is needed.
But as I say I may be the confused one.
Clinical Nurse Consultant
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