-----Original Message-----
From: Jeanne Lenzer [mailto:[log in to unmask]]
Sent: Friday, August 17, 2001 3:44 PM
To: [log in to unmask]
Subject: RE: uncertainty principle
Hi Victor -
Thank you very much for your explanation. It seems to me (and forgive me,
I'm merely a journalist here trying to learn) - but it seems to me that what
you say is true - but that it may not be relevant to the study protocol that
included that paragraph.
The uncertainty principle, it seems to me, is what should be operative in
order to determine whether a study should be undertaken at all. Do we know
if drug A is definitely better than placebo? If we don't know the answer to
that, then and only then, is a study ethical. However, once we determine
that we are uncertain and a study is ethical - to allow clinicians to remove
patients from randomization still seems to be risky to me and I wonder about
that undermining the study's genuine randomness.
For example, what if a clinician has a bias that the drug must work better
than placebo and therefore chooses to pull out a number of the "sicker"
patients but not the less sick patients because he or she thinks "it's
really important that my patient get the active drug"? Could that change
the spectrum of patients receiving treatment vs. non-treatment? Also, what
if the researcher has vested interests (is receiving drug company funding) -
could she or he then (consciously or unconsciously) pull patients out of the
randomization process in a manner that influences the process? I guess a
lot of this depends on when the patient is pulled - before or after
randomization? But even then, prior exclusion of all "really sick" patients
could affect the process? Or am I hopelessly lost?
Thanks much
jeanne
-----Original Message-----
From: [log in to unmask] [mailto:[log in to unmask]]
Sent: Friday, August 17, 2001 2:55 PM
To: [log in to unmask]
Subject: RE: uncertainty principle
This is not liberal, it is ethical. If there is no doubt that active
treatment is in the best interest of the patient then not offering it to her
would be substandard care (same for clearly contraindicated medication).
Only those patient-physician duets that are certain that they do not know
whether treatment A is better than treatment B are in a reasonable situation
to join the study.
There is no way around this. The dangers of not following this principle is
patient desertion, off-study use of study medication, and other forms of
noise that will limit the ability of the study to show a treatment effect
resulting in a monumental waste of time and resources for all involved.
Does this answer your question?
V
> ----------
> From: Jeanne Lenzer[SMTP:[log in to unmask]]
> Reply To: [log in to unmask]
> Sent: Friday, August 17, 2001 1:32 PM
> To: [log in to unmask]
> Subject: uncertainty principle
>
> Could anyone explain the pros and cons of the following:
>
> Uncertainty principle (absence of proof): Further inclusion and exclusion
> criteria are not specified precisely but are guided by the uncertainty
> principle (or absence of proof for that particular patient). If, for
> whatever reason, the clinician is convinced that a patient fulfilling the
> above criteria should be treated, that patient should be given open label
> drug and not randomized. If the clinician is convinced that a patient
> should not be treated (for whatever reason), the patient should not be
> included in the trial. Only those patients who fulfill the eligibility
> criteria AND for whom the clinician is still substantially uncertain about
> the balance of risks and benefits of active drug should be randomized.
>
> Can this kind of enrollment liberalism cause a failure of true
> randomization? Does it introduce spectrum and other biases?
>
> Thank you any and all for any insight you can give this underfed
> journalist.
>
> Jeanne Lenzer
> Freelance writer
> 191 Otens Rd.
> Ellenville, NY 12428
> USA
> Office phone: 845-647-3670
> Office fax: 845-647-3670
> Cell phone pager: 914-399-5001
> [log in to unmask]
>
>
>
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