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Clinical Trials:
A human safety net for new drugs & treatments

by Jeff Worley

Clinical trials have suffered their share of tribulations lately.

The April 22, 2002, issue of Time included a lengthy article titled "At Your Own Risk" that chronicled the slipshod study headed up by Dr. Michael McGee at the St. John Medical Center in Tulsa, Oklahoma. His experimental vaccine for malignant melanoma, a particularly nasty type of cancer, was making over a third of the trial's participants sick, a fact that McGee kept to himself before the trial was shut down.

Far more serious was the outcome of a clinical trial in Maryland. Ellen Roche, 24, a technician at the Johns Hopkins Asthma and Allergy Center, was one of three healthy volunteers who agreed to participate in a Hopkins clinical asthma trial to evaluate the effects of a chemical irritant. Two days after inhaling the chemical, Roche developed a cough, fever and muscle pain. These ailments soon led to respiratory distress, and within a month she was dead.

These incidents—and others that have been spotlighted in the press—have led some people to overgeneralize the dangers of clinical trials.

"Although there are some risks associated with most clinical trials, the truth is that clinical trials are usually very safe—the vast majority of subjects are not harmed," says Ada Sue Selwitz, director of the Office of Research Integrity (ORI) at the University of Kentucky. The ORI supports six federally mandated review committees: three Medical and a Nonmedical Institutional Review Board (IRB), the Institutional Animal Care and Use Committee, and the Radioactive Drug Research Committee.

"Clinical trials are a vital and necessary part of America's medical research system. They have proven to be the best mechanism for testing potential drugs and separating the ones that work from the ones that are ineffective or potentially harmful," says Selwitz, who is past president of the Applied Research Ethics National Association and currently a member of the NIH Regulatory Burden Working Group. "Almost all medical and bioethical experts agree that it's important to have clinical trials and that it's equally essential to put into place protective safeguards for patients."

Assuring that these safeguards are in place is at the heart of IRBs. At UK, the IRB—a group of doctors, other health-care providers, and community members—reviews all research studies to protect the rights of research volunteers and ensure that the study doesn't cause unnecessary risk to participants. Selwitz says that even before it was required by federal regulations in 1981, UK established an institutional review board because the university "has always been committed to conducting ethically appropriate research."

Across campus in his VA Hospital office, John Thompson, who has been a professor of medicine at UK since 1980, helps researchers with the nuts and bolts of clinical trials. Thompson now heads up the University of Kentucky Clinical Research Organization (UKCRO), which does everything from helping to train researchers on how to conduct clinical trials to providing the critical link between faculty and industry.

"The bottom line is, there is a web of protection that governs clinical research," says Wendy Baldwin, UK's new vice president for research. "The IRB is a vital part of this web, but we shouldn't lose sight of the importance of educating all our staff who are conducting clinical studies. Trained staff are really the front line in protecting people who participate in clinical trials. Other safeguards include data safety monitoring boards that are specifically constituted to assess ongoing risks and benefits of a trial and federal agencies such as NIH and the FDA, which provide additional oversight," says Baldwin, who brings 30 years' experience at NIH to her position at UK [also see From the Beltway to the Bluegrass].

There are currently 531 clinical trials under way at UK, according to Larry Iten, associate director of the ORI. Over 1,400 researchers are involved in these trials, and many work on more than one. For more information on how to participate and the research expertise available at UK, go to www.mc.uky.edu/research/clinicaltrials.htm. Meanwhile, read about six of these research trials.

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