The clinical trials office at Iowa Health – Des Moines opened five years ago, and now, said manager Gretchen Burnett, “I get contacted several times a month” by companies or institutions looking for a partner.

A clinical trial is a real-world test of a drug, therapy or method of treating medical patients, and it has become a huge part of the health-care landscape. Right now, more than 13,000 trials are being conducted on drugs and biological treatments across the United States. Every year, more than 100,000 patients take part in trials sponsored by the National Institutes of Health, and many more participate in trials run by pharmaceutical companies.

Iowa is considered a prime location for trials, said Dr. Bruce Hughes at Mercy Medical Center’s Mercy Ruan Neurology Clinic. “We’re considered a very desirable location to do trials,” said Hughes, who has worked on a number of trials relating to multiple sclerosis. “The National Institutes of Health, the Food and Drug Administration and pharmaceutical companies like to have us participate. We have ‘clean’ numbers, because we have some of the lowest dropout rates.”

When patients commit to participation in a clinical trial, they’re signing up for lots of trips to the doctor and possibly some uncomfortable experiences. They’re free to drop out, but the researchers dearly want them to stick with it.

Hughes, who moved here from Southern California in 1995, said, “I love being in Iowa; when Iowans say they’ll do something, they do it. I can’t say that about my upbringing on the West Coast.”

To gather the results they need, researchers look for people with the relevant medical condition, or who simply fit the required demographics of age or lifestyle. In the typical drug test scenario, those who agree to participate don’t know if they’re getting a medicine or a placebo.

Many participate out of the hope that a new drug will produce better results in their particular case. Others take a larger view. Burnett said, “There are some altruistic individuals who say, ‘Maybe I won’t benefit, but the information we gain may help my grandchildren.’”

Burnett handles pharmaceutical clinical trials, and her department typically is involved in about 30 such studies at a time. Current trials involve epilepsy, diabetes, skin infections and more.

Each clinical trial at Iowa Health must be approved by its Institutional Review Board, which was accredited by the Association for the Accreditation of Human Research Protection Programs in December 2004.

Members of the Iowa Health IRB include physicians, pharmacists, community representatives, a statistician and, at times, an attorney. If participation in the trial is approved, and advertising is planned, the panel must approve those materials and the wording of the informed-consent document that must be signed by each participant.

Brian Sheesley works with government-sponsored trials that are brought to Iowa Health. Partners can include other hospitals and even, in the case of a current project on the treatment of Alzheimer’s disease, a local fitness center.

Initiated by the U.S. Centers for Disease Control and Prevention, the trial is investigating the effectiveness of various prevention strategies when used by older adults. Dr. Robert Bender is the lead person at Iowa Health, and Fitness World West is a local partner.

“We’re working on a brain wellness program that involves diet, meditation and cognitive therapies,” Sheesley said. “We’re testing the effectiveness of intervening early, and we’ll analyze the data for application in a larger study.”

Sheesley also is working on clinical trials involving the treatment of adult methamphetamine addicts; the developmental effects of prenatal exposure to meth; and, in partnership with the University of Iowa, the effectiveness of distracting children from pain during medical treatment.

The Alzheimer’s study is in its third year, and Sheesley said “a federal project that lasts four or five years is not unusual.”

Clinical trials involving new drugs can last even longer. “It takes approximately 10 years from the first tests in humans until it’s approved by the Food and Drug Administration,” The FDA approves about 70 drugs in a typical year, but thousands are in the development process at any given time.

The subject can be highly technical, extremely specific and more than a little intimidating. Here’s one on the ClinicalTrials.gov list, for example: a “Phase III randomized study of tamoxifen versus thalidomide in patients with only a biochemical recurrence of ovarian epithelial, fallopian tube, or primary peritoneal cancer after first-line chemotherapy.”

And the geographic extent of any such clinical trial is likely to be impressive. Researchers handling the one mentioned above are looking for test subjects at dozens of hospitals and clinics in 45 states.

Their invitations aren’t always accepted by individuals or by hospitals. “We’re most interested in research that’s germane to the mission of our organization,” Sheesley said. “I think the institution is open to more clinical trials, but we will continue to be selective.”

“When I reject a clinical trial, I give my reasoning,” Burnett said. “Sometimes the physician doesn’t think it’s worth doing; sometimes we just don’t have the population that’s needed.”

Participation demands a lot of time and paperwork from the hospital staff. On the other hand, “clinical trials can be a selling point when we’re recruiting physicians,” Sheesley said. And when the subject is treatment for methamphetamine users, for example, “a clinical trial opens up some [treatment] slots that would not have been available.”

Federal funding has been strong, Sheesley said, although the subjects being funded do change. “There’s a lot of interest at the federal level in meth treatment,” he said. “Obesity is another one.”

Participants in clinical trials usually receive payment for each visit they make to the hospital as part of the project. “The IRB has to approve the benefits offered,” Burnett said. “For some studies, we will offer money for their time and travel. But it can’t be so much as to be an inducement to take part.”

If the time or the procedures turn out to be more than the patient planned on, “it’s OK to drop out,” Burnett said. “That happens occasionally.”