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Duke Program Tries To Protect Patients From Becoming Guinea Pigs

Posted February 26, 2002

— Behind every cure or treatment for a disease, there are patients who took part in a clinical trial, but recent deaths during research have raised red flags about the system even with the regulations already in place. A program at Duke is trying to protect patients from becoming guinea pigs.

In 1999, 18-year-old Jesse Gelsinger died during a gene therapy trial in Pennsylvania. Last year, a healthy woman died during an asthma study at Johns Hopkins. In a separate study at Hopkins, parents claim their children developed lead poisoning.

"We can both learn by that situation and be humbled by the situation," consortium member Dr. Jeremy Sugarman said.

That concern has led to the creation of a national consortium to examine research ethics at Duke University Medical Center. For the first time, this group will compile information on how clinical trials operate and develop ways to protect patients enrolled in these studies.

Some safeguards are already in place. Each institution has its own review board along with guidelines on ethics.

"No single individual is responsible for looking out for participants in the trial," Sugarman said.

However, there is concern over conflicts of interest, such as trials where researchers have a financial interest. There are many questions that must be answered.

"Are they properly constructed? How much does it cost? Are they trained?" Sugarman said.

If you are interested in taking part in a clinical trial, Sugarman said you should ask plenty of questions about what the study is about, what you get from it and who is behind it.


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