SATURDAY, Oct. 6, 2018 — Although clinical trials are the only way to test the mettle of new drugs and medical devices, just 1 percent of Americans participate in such trials, research experts say.
“Participating as a healthy volunteer is one way that individuals can actually contribute to the development of new medications, devices or procedures,” said Terry Novchich, director of the Penn State College of Medicine Clinical Trials Office.
Some drugs or devices are in development for up to two decades, the Penn State experts pointed out. During this time, they must be tested on healthy volunteers to assess how the body reacts to them. This must be done before the drugs or devices can be used on patients with the diseases the drugs are intended to treat, explained Dr. Neal Thomas, associate dean of clinical research at Penn State.
“We have to understand how these medications and therapies work in healthy individuals; how they’re processed by the body; how they’re broken down,” Thomas explained in a university news release. “All that information is extremely important before vulnerable patients with disease are given the therapy.”
Healthy people are also needed to determine how diseases develop and how the body responds to various stressors.
What volunteers are asked to do varies from study to study. Some people must fill out questionnaires or surveys. Sometimes volunteers must give blood or other biological samples. Others may take drugs, undergo tests or use a medical device.
Researchers must inform all volunteers of what they will be asked to do in a clinical trial ahead of time and receive their consent. Volunteers can choose to drop out of a study at any time.
“The participant will have a full understanding of exactly what is expected, what the potential risks are, and what the potential benefits are,” Thomas said.
The U.S. National Library of Medicine provides more on clinical trials.
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Posted: October 2018