Ethical implications of rejecting patients for clinical trials
Article Abstract:
In a study in the February 9, 1990 Journal of the American Medical Association, reference is made to certain ethical implications that were considered in the selection process of clinical trial participants. Specifically, it was decided not to use a control group, which would have been given a placebo rather than the experimental treatment. The treatment was expected to benefit the patients who received it and, therefore, to withhold therapy from a group who might benefit would be ethically questionable. However, the results of the study indicated that the improvement obtained from the treatment was minor; the therapy was expensive; and the treatment was only demonstrated to relieve symptoms. This makes the wisdom of foregoing a control group questionable. In addition, certain restrictions were imposed that may themselves be considered unethical. The study did not include individuals with drug addictions, evidence of hemolysis, or other types of hematologic disorders that "would interfere with data analysis." This, perhaps, is not sufficient reason to exclude otherwise qualified individuals from the study; these persons would have been in a position to also benefit from the treatment (even though they would have made data evaluation more complicated). This demonstrates an ethical double standard and is an example of fallacious ethical reasoning. However, this is not the only example of research that has been performed without using a control group or that has exercised arbitrary selection procedures. Exclusion of subjects by age is another common occurrence. For example, despite the fact that most myocardial infarctions (heart attacks) occur in individuals in their late 60s, more than 50 percent of all randomized control trials are restricted to younger patients. This, and other related ethical questions, require a more thorough examination by institutional review boards to avoid compromising the results of future studies. (Consumer Summary produced by Reliance Medical Information, Inc.)
Publication Name: JAMA, The Journal of the American Medical Association
Subject: Health
ISSN: 0098-7484
Year: 1990
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Single-donor, marginal-dose islet transplantation in patients with type 1 diabetes
Article Abstract:
A trial was conducted to assess the safety of a single-donor, marginal-dose islet transplant protocol using potent induction immunotherapy and less diabetogenic maintenance immunosuppression in recipients with type 1 diabetes. The results showed that the tested transplant protocol restored insulin independence and protected against hypoglycemia after single-donor, marginal-dose islet transplantation in eight of eight patients.
Publication Name: JAMA, The Journal of the American Medical Association
Subject: Health
ISSN: 0098-7484
Year: 2005
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