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THE PHARMA REVIEW (MAY 2009)

Awareness of the Risk Factors in Volunteers of Clinical Trials

Yogesh Murti, Pallavi Verma and Devender Pathak

Clinical trial is the scientific term for a test or study of a drug or medical device in people. These are done to test whether new products are safe and work against disease. Some treatments that are being tested have side effects that can be unpleasant, serious or even life-threatening. Because the treatments being studied are new, doctors don’t always know what the side effects will be. Many side effects are temporary and go away when the treatment is stopped. But others can be permanent. Some side effects appear during treatment, while others may not show up until after the treatment is over. The risks depend on the treatment being studied and all known risks should be fully explained to volunteers by the researchers.

Behind every new medicine are the volunteers who take part in clinical research studies. Practitioners of clinical trials have a responsibility to ensure that patients’ participation in research be informed and voluntary. They monitor studies to help make sure that there is the least possible risk to volunteers and that the risks are reasonable in relation to the expected benefits. Food and Drug Administration (FDA) sets the rules to make sure that volunteer who agree to be in the studies are treated as safely as possible. To help volunteers decide if they want to be in a study, FDA requires that volunteers be given complete information about the study before they agree to take part. This is known as informed consent. FDA requires that people should be well informed of the purpose of the research, how long the study will take, what will happen in the study and which parts of the study are experimental, possible risks or discomforts, possible benefits, whether any medical treatments are available if volunteer are hurt, what those treatments are, where they can be found, and who will pay for the treatment, volunteer rights, or if volunteer get hurt he can withdraw from the study of anytime. 

 

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