• Michael H Kottow.
• Universidad Diego Portales, Santiago, Chile. mkottow@gmail.com
• Arch. Immunol. Ther. Exp. (Warsz.). 2009 May 1; 57 (3): 157-64.

AbstractThis article takes issue with those who defend a brand of clinical research ethics that tends to substitute the ethics of clinical care of patients being recruited as trial subjects. The distinction between therapeutic and non-therapeutic studies is being disregarded by arguing that research is concerned with the pursuit of knowledge rather than with the medical benefits for patients. Non-competent patients may therefore be recruited for studies that will offer them no medical benefits in spite of involving them in the inherent risks of any biomedical trial. Supported by the World Medical Association, clinicians tend to shun the use of placebos in randomized trials, because of the therapeutic void created in the control group. Nevertheless, investigators continue to consider that scientific purity demands the use of placebos as the most appropriate comparator, even if risks to patient-subjects are increased. Equipoise and clinical equipoise have been suggested as adequate criteria to evaluate the need for a clinical trial, when genuine uncertainty about the equivalence of medical measures requires clarification. If equipoise is understood as a balanced situation where alternatives are equivalent and exchangeable in the view of experienced and current medical thought, no comparison seems warranted until a substantiated doubt about their true equivalence appears. Whereas respecting equipoise is an important measure to curb redundant research, new trials become mandatory if equivalence is reliably questioned. In the best interests of patients being recruited for clinical trials, they should continue to be the full beneficiaries of clinical ethics, in addition to receiving the protection of research ethics. Placebos and sub-medication for control groups are to be used sparingly, and best existing therapy should be employed as control when new and promising agents are developed.

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