From: Diane
Newsgroups: sci.med
Subject: Re: depo provera LONG
Date: 5 Nov 92 15:50:55 GMT
Organization: University of Missouri

In article <68872@cup.portal.com>
amigan@cup.portal.com (R Michael Medwid) writes:
 
>If you were part of a clinical trial you should have been informed of this.
>MDs are often compensated by drug companies for their participation in
>such studies.  I'm not sure if legally they are required to inform patients..
>but from a professional and ethical standpoint they should.
 
Any researcher who does clinical trials must have his/her protocol
reviewed by the Institutional Review Board (IRB) or , if the patients
are in a VA hospital, by the Research and Development Committee. These
boards will determine if, and what sort of informed consent is required.
The boards are usually made up of local physicians and lay people.
Studies that expose the patient to 'significant' risk (drug studies,
experimental 'appliance' studies, etc) usually require a written
consent of the patient (many states will not accept the consent
of next-of-kin). These consents are quite long and detail exactly
what the patient can expect- any tests, risks, discomfort, etc. Care
is taken to insure that the patient does not feel coerced. This is
usually done by having someone other than his own personal physician
approach him about the study, and through written and verbal assurrance
that the patient's refusal to participate in the study will have no
impact on the level of care he will receive.
Verbal consents are usually required for 'concurrent' studies. These
are studies in which the researcher has no impact on the types of drugs,
procedures, etc that are used (they are dictated independently by the
patient's private physician based on the physician's assessment of the
patient's need). The researcher acts as an observer. The physician will
note whether or not consent was given in the progress notes.
The few exceptions for informed consent are: medical chart reviews (the
patient himself is not involved and any data is collected without a patient
identifier); questionnaires (the patient chooses whether or not to
respond and what to respond to); and studies on existing pathology specimens.
Behavioral and psychological studies also require a similar review process
but I am not as familiar with it.
 
If a study requires lab tests, EKGs etc, above and beyond those which
would normally be given to a patient not signed into the study, the
researcher pays the costs of these tests. Often special equipment
is also necessary (for assays, etc). For this reason, physicians often
approach drug companies to sponsor these studies.
 
I did want to address what I see as a misconception about drug
studies. The ideal study is one in which the researcher does not
have any preconceptions about the outcome. For example, few researchers
would use normal saline or sterile water as the control in a study
looking at the effectiveness of a strong narcotic; the outcome
would be no 'surprise'. Instead, a researcher would try to match an
experimental drug against a similar drug that is routinely used.
The only placebos that I have seen used involved studies in which
the routine procedure did not involve drugs.
Disclaimer: All of the studies I'm aware of are conducted at large
medical facilities. I don't know what safeguards are in place concerning
private physicians who are not affiliated with teaching hosptals. It
is my own feeling though, that most private physicians do not have a
large enough caseload to make many studies feasable (other than the
"there I was..." articles in JAMA).
 
Diane
 
Newsgroups: sci.med