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Release: April 29, 1999

UI clinical trials link patients, research and industry

IOWA CITY, Iowa -- Would you be willing to adhere to a strict diet for five years? Or sit in a park breathing pollens and molds when you know you suffer from allergies? How about having your lungs examined using bronchoscopy, or having blood drawn on a regular basis?

Every year hundreds of Iowans volunteer to help evaluate experimental treatments in hopes of either improving their own health or contributing to medical science, or both. They might try new medications, alter their lifestyles and diets, or undergo treatments with new medical devices. It's all part of participating in clinical trials at the University of Iowa.

Clinical trials are important to the university for a number of reasons, not the least of which are recognition for the UI and its faculty members, educational opportunities for students involved in the research, and funding.

But according to Charlotte Talman, director of the recently formed UI Clinical Trials Office, a particularly significant role that clinical trials fill is providing new treatments to patients who need them.

"The most important thing that clinical trials do is bring new devices and medications to patients -- the latest, newest, most recently developed things that are not available anywhere else," Talman said. "That's the reason for clinical trials -- to bring better care to patients and the people of Iowa."

Judy Hupfield of Iowa City experienced that kind of care when she participated in a UI breast cancer prevention trial studying the effects of the drug tamoxifen.

"I think the psychological effect on me was really wonderful," she said. "It took all the anxiety about that disease out of my life because I was so well cared for while I was in the trial. It was basically for selfish reasons that I got involved but I'm glad for the positive results and hope that more women get involved in studies and really take an active role in taking care of themselves."

The UI attracts between 180 and 200 new corporate-funded studies a year. Most are for pharmaceutical companies or manufacturers of medical devices. Conducting clinical trials is an important way to build partnerships with these companies, who need to get their products approved for use.

"There is more pressure on industry to get studies up and going, get them conducted quickly and get the results," Talman said. "There's also a lot of competition for their funds, from doctors' offices, smaller hospitals and some places that are set up just to do clinical trials. Having this office is one way to be more responsive to what industry wants."

Handling the details for these corporate-funded studies is Talman's responsibility. The office, a unit of Research Services which is part of the Office of the Vice President for Research, was formed in July 1998 to facilitate communication between industry, sponsors and faculty researchers involved in clinical research projects. It serves all colleges at the UI.

The office is made up of Talman and her secretary, Cindy Tisor, and it is often the first contact a company has with the university. Talman fields inquiries and refers the information to the appropriate UI faculty.

"It's a matter of matching up the right investigator with the right company," Talman said.

Once that match is made, Talman reviews the written contract for the trial and suggests changes to the company in order to ensure the contract complies with UI standards, Iowa law and the researcher's rights concerning the study. She helps researchers set up accounts for the grant funds and presents orientation sessions for research teams on how to set up a clinical trial.

"Charlotte is like a guardian angel," said Mary Spaight, an oncology nurse and assistant nurse manager at the John and Mary Pappajohn Clinical Cancer Center at the UI Hospitals and Clinics. "She keeps tabs on everything. With drug studies or company studies, she's very protective of the UI investigators and nurses. She's been a tremendous asset."