Is an RCT of an Ebola drug ethical? - Bioethics @ TIU
Fundamentación de la bioética : Is an RCT of an Ebola drug ethical?
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The title question here is of course over-simplified. The development of an experimental drug to treat a devastating disease, during an outbreak of that disease, raises many ethical concerns. Perhaps the most urgent of these is how to make the drug available to as many people with the disease as possible, because the risk of the disease itself makes the risks of the drug more acceptable in light of its potential benefits. This is “direct” benefit to the patient/experimental subject, not just the “indirect” benefit to society of finding out whether the drug is really effective and safe.
The challenge is, in the urgency to offer the drug with therapeutic intent, it can be hard to tell whether any benefits are due to the drug or other medical care—or just differences in the effects of the disease from person to person. Pivotal to answering that question is the randomized clinical trial (RCT), in which people with a condition to be studied are randomly designed to get the drug, or not. Often, “not” means a placebo, especially when there is no standard drug already available to treat the disease.
The title question here is of course over-simplified. The development of an experimental drug to treat a devastating disease, during an outbreak of that disease, raises many ethical concerns. Perhaps the most urgent of these is how to make the drug available to as many people with the disease as possible, because the risk of the disease itself makes the risks of the drug more acceptable in light of its potential benefits. This is “direct” benefit to the patient/experimental subject, not just the “indirect” benefit to society of finding out whether the drug is really effective and safe.
The challenge is, in the urgency to offer the drug with therapeutic intent, it can be hard to tell whether any benefits are due to the drug or other medical care—or just differences in the effects of the disease from person to person. Pivotal to answering that question is the randomized clinical trial (RCT), in which people with a condition to be studied are randomly designed to get the drug, or not. Often, “not” means a placebo, especially when there is no standard drug already available to treat the disease.
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