Clinical trials are part of the development process of new medicines to ensure their safety and efficacy. While clinical trials are directed toward the common good and many have benefited from them, they also pose health hazards that may sometimes become fatal.
On Sunday, Rennes University Hospital in France announced that a man who was left brain-dead after participating in a clinical trial for a painkiller drug called Bial has died. Five other participants were hospitalized but are now in stable condition.
The Portuguese firm testing the drug said it is now working with health authorities, who have started their manslaughter case investigation.
The news brought all eyes on the practice of testing experimental drugs on human volunteers.
Clinical trials are designed to find better treatments and diagnostic modalities. Such tests do not only affect the communities, but the individual participants as well.
"There are both benefits and risks associated with clinical trials," the National Institutes of Health states.
Below are the benefits and risks of joining clinical trials.
• Being able to have access to new treatments and diagnostic procedures that are not yet available to the public.
• Having the opportunity to obtain expert medical advice and care from top health care professionals and institutions.
• Playing an active role in one's own health and being able to better understand diseases and medical conditions.
• Helping the society by contributing to medical research and enriching scientific knowledge for the common good.
• People with rare conditions, which do not have a precise cure yet, may also be given a chance to try possible treatments.
• Being subjected to unfavorable, serious or even fatal side effects.
• Risking the possibility that the treatments may not be effective.
• Requiring participants to spend a lot of time for traveling to laboratories, engaging in experiments and being admitted to the hospital.
• Spending own money as some costs may not be shouldered by health insurance.
As it is a "trial," it is critically vital for people to remember that participants may not receive direct benefits.
Each clinical trial has specific benefits and risks, which should be described in detail in the participant information sheet and informed consent document provided by the company.
Before officially participating in a clinical trial, the individual should receive explanations of the risks from the research team. The participant should also be given a chance to ask questions. Most importantly, all participants should read, understand and sign a consent form prior to the experiments.
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