June 25, 2011 | Posted By David Lemberg, M.S., D.C.

Randomized clinical trials (RCT) may be the Tyrannosaurus rex of the clinical research field. Formidable, very powerful, and doomed to extinction.

The as-if-ripped-from-today's-headlines 1991 article, "Of Mice But Not Men: Problems of the Randomized Clinical Trial",1 recommends reevaluating the preeminence of this method of conducting clinical research. Insisting on RCTs represents clinging to tradition in the face of new imperatives.

An RCT is a microcosm of the ongoing debate between the rights of the individual and utilitarianism. RCTs are all about the good of society. The individual subject is merely a subject - her right to receive the best possible treatment is subjugated to the greater good.

As the authors note, a RCT creates an intolerable situation for a physician. An ethically compromised situation. How can she refer a patient for randomization if one of the choices seems preferable? If the study is a placebo-controlled trial, how can she refer a sick patient in the knowledge that one of the groups receives no treatment? How can the physician provide sound counsel to his patient when sufficient information is just not available?

Clinical research has become big business. All the parties are in bed with each other. The fact that physicians are paid per referred research subject is profoundly disturbing.

In pursuit of the Holy Grail of RCTs, the rights of individual study participants have been trampled in the dust. Physician ethics are sacrificed. The doctor-patient relationship is severely compromised. Who benefits? That is a very dark road.

Why not institute research protocols that restore the primacy of the rights of the individual? Hellman and Hellman offer several appealing alternatives - uncontrolled clinical trials and prospective matched-pair studies (without randomization). Importantly, "patients would receive the treatment recommended by their physician". The authors conclude, "Techniques appropriate to the laboratory may not be applicable to humans."

They highlight The Physician's Oath of the World Medical Association: "Concern for the interests of the subject must always prevail over the interests of science and society."

It's time to move on. RCTs may be appropriate in limited circumstances. New methodologies need to be instituted worldwide.

1Hellman S, Hellman DS: Of Mice But Not Men: Problems of the Randomized Clinical Trial. N Engl J Med 324:1585-1589, 1991

The Alden March Bioethics Institute offers graduate online masters in bioethics programs. For more information on the AMBI master of bioethics online program, please visit the AMBI site.

1 comments | Topics: Bioethics and Public Policy , Doctor-Patient Relationships , Ethics in Clinical Trials , Health Care Policy , Patient Autonomy



John wrote on 06/25/11 4:59 PM

I am not in agreement with this analysis. Placebo-controlled trials will not be approved if there is a treatment which has been demonstrated to be effective. If equipoise exist neither arm is preferable. Not sure what "seems preferable" means. RCTs provide the highest degree of proof allowing us to know what is preferable, as opposed to seems preferable. We can protect the patients if the researcher is not the patient's physician and proper informed consent is utilized.

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