Often, researchers know prior to or early into a research study that treatment s

Question

Often, researchers know prior to or early into a research study that treatment subjects are getting a significantly beneficial treatment and that control subjects can never catch up and may suffer significant health risk or even death by getting a placebo rather than the experimental treatment. What ethical questions are raised by these situations? Similarly, is it ethical to try new drugs or experimental procedures or terminally ill patients? What ethical issues are raised by research conducted with terminally ill patients in this regard?

Explanation / Answer

The use of placebos in clinical trials is a very controversial subject. However, Millum and Grady (2013) have discussed four conditions under which the use of placebo in the control group can be justified:

A major complication with terminally ill patients is that they are almost always enrolled in Phase 1 trials (which are ones in which a particular drug is administered to a human being for the very first time). The purose of such a trial would not be to find if the drug cures the illness, but rather ascertain the drug's usability, safety, dosage, and side effects if any. It would be great if it contributed to the treatment, however, one has to be extremely cautious about not giving any kind of false hope to get subjects enrolled into the trials. Also, such trials are never without risk. It is finally up to the clinical to arrive at the optimal benefit-to-risk ratio.

I have cited the following study:

Millum, J., & Grady, C. (2013). The Ethics of Placebo-controlled Trials: Methodological Justifications. Contemporary Clinical Trials, 36(2), 10.

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