Clinical trials aim to advance medical research, help Utah patients

Published: Friday, May 11 2012 7:00 p.m. MDT

While the risks might scare some people away, Trewhitt said a bigger problem is that many people just aren't aware that trials are available in their area. He said patients ought to have the opportunity to make an informed decision, weighing the risks and the potential benefits of being involved in any particular study.

A list of the ongoing U.S. National Institutes of Health-sponsored clinical trials can be found online, at www.clinicaltrials.gov. Those being conducted at the U. can be found at www.healthcare.utah.edu/clinicaltrials. Trewhitt said more than 137 trials are actively recruiting in Salt Lake City, 23 in Ogden and about 10 in Provo. Far more are in progress at academic institutions, hospitals and private businesses statewide.

"There is a lot of health care research infrastructure here," he said, adding that pharmaceutical companies seek out the available and dependable patient population, as well as the reliable research base that Utah offers.

"It is clear they are impressed with Utah," Trewhitt added.

Spigarelli's team has recruited more than 800 of the 1,000 subjects needed for a nationwide study on the causes and treatment of pneumonia in kids. They have surpassed the efforts of multiple partners in the project, even helping to redefine parameters of the study.

"People are more willing to help and volunteer here," Spigarelli said. "They're in it to help others."

While risks should be considered, patient protections are built into the process. An independent Institutional Review Board, made up of providers, lawyers, patient advocates and others, must approve each trial "with an eye toward ensuring patient rights," Trewhitt said. Institutions conducting trials, whether they are public or private, are also required to comply with strict regulations set by the FDA.

"We can't have the treatments of tomorrow without doing research today," Spigarelli said, adding that the level of detail involved in a clinical trial is "much higher than what you'd get if you were just seeing a doctor and the doctor was giving you medicine."

Trials are carefully monitored. Instead of visiting a doctor every six months, some studies require weekly visits. And when problems arise, trials are terminated immediately.

"We don't stop being doctors and nurse practitioners or other health professionals," Spigarelli said. "If somebody is having a bad side effect, we stop it. Even if we don't know it was caused by the drug."

He believes all research must seek to improve clinical care in some way. Studies wouldn't be approved "if we didn't think they will work," Spigarelli said. "We can't do a study just because we want to know something."

Unknown reactions are equally important to the research, as the idea is to present specific claims pertaining to each drug, procedure or recommendation.

"We want to be able to say that this drug works for this condition, in this age group, and at this dose," Spigarelli said. "We also want to know how frequently it works," which brings added importance for larger groups of subjects.

In addition to drug testing, institutions also assess surgical procedures, medical efficiencies and even behavioral interventions.

The Huntsman Cancer Institute's Qigong project aims to find ways to decrease fatigue and balance problems that can result from various treatments of prostate cancer in males 55 and older.

"We want to know if exercise makes a difference," said Kathleen O'Connor, research coordinator at Huntsman. For 12 weeks, participants gather twice a week for an hour of the Qigong.

"We think if we can improve physical functioning in this population, we can improve balance and reduce falls, but also help in improving their quality of life," O'Connor said.

The next round of research begins June 5, and anyone interested can contact O'Connor by calling 801-587-4556.

While the tai chi-like exercise seems harmless, there may be risks involved in any type of research, Trewhitt said, adding that it is important to include a person's regular doctor in any decision of clinical trial participation.

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