ABSTRACT: Managing Conflicts of Interest in the Conduct of Clinical
The interaction between medical research and for-profit corporations
is not new, but it has expanded considerably in recent years.
Some of the recent trends may accelerate the research process,
particularly when large clinical trials are required.
a renewed commitment to the application of high ethical standards
is essential to ensure that societal trust in research is not
eroded, subjects enrolled in trials do not become merely a means
to an end, and medical research is efficiently translated into
clinical advances that will benefit future patients.
focuses on the analysis of conflicts of interest in the conduct
of clinical trials in both academic and community-based settings.
Specifically, it discusses how the roles of research scientists
and clinical practitioners differ and the importance of ensuring
that participants' consent to enroll in clinical trials is not
the result of confusion about the goals of an experimental treatment
that may resemble clinical care.
The article also discusses the
potential conflicts of interest that can arise when clinicians
stand to gain from enrolling their own patients as subjects in
clinical trials and examines various instances in which disclosure
of information regarding funding and compensation may serve to
minimize such conflicts.
This article emphasizes that to preserve
the integrity of research and to protect the welfare of human
subjects who enroll in trials, physicians should have adequate
training in the conduct of research and be familiar with the
ethics of research.
When a physician has treated or continues
to treat a patient who is eligible to enroll as a subject in
a clinical trial conducted by the same physician, someone other
than the treating physician should obtain the participant's informed
Finally, the article addresses disclosure of financial
incentives and related funding issues.
01/02/2002; Journal of the AMA
Reuters Health, UK, 7/08/02
British Medical Journal
same practice in U.S.
Assoc of American Medical Colleges
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