Clinical trials - are they ethical?

Article Abstract:

There are some people who would say that the randomized clinical trial is unethical. The underlying principle of the randomized clinical trial is that two or more treatments are compared with each other without bias. Effective randomization prevents the slanting of results by preventing the comparison of two different groups of patients that are not, scientifically speaking, comparable. Any differences in treatment success between the groups may then be reliably attributed to the treatment and not to intervening factors. The argument against this form of research is that rarely are both competing treatments regarded as equal. In most cases, physicians believe that one of the treatments is, in fact, superior. By permitting patients to be randomized into one group or the other, physicians are, in a sense, allowing some patients to receive treatment they believe to be inferior. This is regarded as unethical by some, but the argument is fallacious. The error in the reasoning stems from the fact that inappropriate emphasis is placed on the belief, rather than the knowledge, of the physician. It is mistaken to accuse a physician of unethical behavior because he refuses to play out a hunch on the patient. It must not be thought that, in the modern era of medicine, that the hunches of physicians are likely to be reliable and that treatment should be determined on this basis. For example, in the past decade, many physicians believed that the treatment of a particular type of heart beat irregularity would help save the lives of patients. A major randomized controlled study was conducted to evaluate the treatment. The study was never completed. Before the end of the study, it was clear that the patients who were receiving the treatment believed to be best were dying faster than the patients receiving the placebo treatment. The opinions of many talented clinicians were simply wrong. Just because a physician genuinely believes one treatment to be best, does not mean that this is so, and it does not ethically justify inferior treatment. (Consumer Summary produced by Reliance Medical Information, Inc.)

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Of mice but not men: problems of the randomized clinical trial

Article Abstract:

In the past, medical knowledge often accumulated as the result of educated guesswork on the cause of disease and the potential for effective treatments. However, today a scientific approach predominates, and the randomized clinical trial is regarded as the most important indicator of the effectiveness of a therapeutic procedure. These methods are used because with a large enough group of patients and appropriate randomization, the individual variation among patients does not affect the outcome of the treatment. Two treatments may then be compared without bias. Unfortunately, the randomized clinical trial is incompatible with the ethical foundation of medicine. The underlying ethical basis of medicine is that every physician must do his best to treat each patient individually. By including a patient in a randomized clinical trial, the doctor is turning the treatment of the patient over to chance. If a physician honestly had no knowledge at all that might make him select, for example, treatment A over treatment B, then allowing random treatment would be ethical. However, this is rarely the case. A physician generally has a hunch about whether an experimental treatment might be better or worse than other treatments, and may believe one treatment to be more or less toxic than another. To not provide a treatment he believes to be better, the physician is committing a breach of ethics, regardless of whether the physician is actually correct in his opinion. New alternatives to the randomized clinical trial must be found that can add to medical knowledge while allowing the physician to meet his responsibility to treat each patient to the best of his knowledge. (Consumer Summary produced by Reliance Medical Information, Inc.)

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Protecting research subjects - what must be done

Article Abstract:

This article draws the attention of all clinical research investigators to the importance of adhering to the international and moral and ethical standards for protecting human subjects participating in clinical trials. The Secretary of Health and Human Services of the United States calls for accountability of all involved, particularly the Institutional Review Boards, and for strict compliance with the standards laid down by the Government and the Office for Protection from Research Risks.

United States, Safety and security measures, Powers and duties, Independent regulatory commissions

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