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International Journal of Medicine and Health Development

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The use of placebo control in clinical trials: An overview of the ethical issues involved for the protection of human research participants.

FN Chukwuneke, IC Onwuekwe, OC Ekwueme

Abstract


A placebo-controlled clinical trial is a trial where some of the volunteers are given the new drug being tested, and the other volunteers are given a placebo. A placebo looks exactly like the experimental drugs in every respect both in appearance and wrappings which, is prescribed in identical way to the real drug. The experimental group receives the real
drugs while the control group receives the placebo. When patients believe that a certain medication will improve their condition, that fact alone can cause certain positive effects when combine with pill, an injection or even a surgical procedure. Researchers can utilize such adventitious effects and more precisely determine the actual therapeutic benefit of a new treatment. However, the use of placebo in clinical trials has been controversial with many stake holders in clinical research expressing different opinions. It is usually not problematic to use a placebo in clinical trials when testing a new treatment in absence of a known treatment. On the other hand, resort to placebo controls becomes ethically
controversial when researchers wish to introduce a new treatment as a possible successor or competitor drugs whose use is currently a standard practice. More problematic and controversial is the use of invasive placebo in interventions in surgical trials. This article is therefore, a critical presentation of the ethical issues involved in the protection of human
research participants in the presence of placebo controlled clinical trials



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