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dipanpatel replied to the topic Placebo-controlled trials: Are they ethical? Are they necessary ? in the forum Clinical Research Basics 7 years, 5 months ago
I do think that having placebo-controlled trials are ethically sound and necessary. There are guidelines place with a huge emphasize on when a person should be placed in a trial. The well-being of participants should be considered, and whether or not it is worth having the patient take part in this study when they are already receiving adequate treatment and whether or not being on the trail might make them worse. “Placebo controls are not to be used if there is evidence of the efficacy of another treatment or “good evidence” that the experimental therapy is effective. These guidelines call on institutional review boards to perform a careful risk-benefit analysis when considering whether to allow a placebo-controlled trial.” There are also guidelines placed on when a PCT can take in a trial. “(1) when there is no proven effective treatment for the condition under study; (2) when withholding treatment poses negligible risks to participants; (3) when there are compelling methodological reasons for using placebo, and withholding treatment does not pose a risk of serious harm to participants; and, more controversially, (4) when there are compelling methodological reasons for using placebo, and the research is intended to develop interventions that can be implemented in the population from which trial participants are drawn, and the trial does not require participants to forgo treatment they would otherwise receive.” In short, ethical issues arise when the participants are looked over. If their health and safety is placed in priority rather than the success of the trial and or other corrupt motives, then there would be no issue. The guidelines above facilitate in the prevention of unethical methods, and therefore having PCT is still a very efficient method of comparing data.
Chiodo, G. T., Tolle, S. W., & Bevan, L. (2000). Placebo-controlled trials: good science or medical neglect? Western Journal of Medicine, 172(4), 271–273.
Millum, J., & Grady, C. (2013). The Ethics of Placebo-controlled Trials: Methodological Justifications. Contemporary Clinical Trials, 36(2), 10.1016/j.cct.2013.09.003. http://doi.org/10.1016/j.cct.2013.09.003