Newsletter Summer 2002

Should You Enroll in a Clinical Trial
Meet David L. Weber, New Chairman of the Board
Don't Age, Exercise Instead
New Sling Procedure for Stress Incontinence
Welcome New Physicians and Clinicians

Should You Enroll in a Clinical Trial

Donna Parsons was driving when she heard an ad on the radio for volunteers to be in a clinical research study. “It was something that related to me, and I fit into the category,” Parsons says. “I thought I’d call and find out what it was about.”

The study involved hormone therapy. Donna is known to her friends as someone who doesn’t like to take medication, even when recommended by her doctor. They thought it was out-of-character that she was willing to take pills in a study. Her reasons were twofold.

“It was interesting to me, and I wanted to learn more,” she recalls. “I felt it was a little bit of a contribution to what all women go through. You hope you can do something for somebody else, whether you know them or not.”

Another research volunteer, Maria Gutierrez, was suffering from a painful sinus infection when she heard of a trial for sinusitis. “At the time I didn’t have any medical insurance,” says Gutierrez. “The sinusitis study helped a lot. It cleared up totally.”

While people have different reasons for volunteering, the purpose of the research itself remains steadfast. “The purpose,” says Dr. James Cook, Medical Director of Clinical Research, “is to help the pharmaceutical industry and the medical profession develop new drugs.”

Research studies are conducted under the supervision of the Food and Drug Administration (FDA). A pharmaceutical company files a new drug application with the FDA, then must follow strict requirements, including documentation that is supposed to tell the drug's whole story. A crucial part of the process is what happened during the clinical studies. The controlled clinical trials are especially important because they provide the only basis, under law, for demonstrating effectiveness. They answer the question: "Does this drug work for the proposed use?"

The FDA says it's important to realize that no drug is absolutely safe. There is always some risk of an adverse reaction. When the benefits outweigh the risks, the FDA considers a drug safe enough to approve.

The Clinic started participating in clinical trials in 1990 when Infectious Disease physician Richard Tucker had to get creative to treat a new patient. “I had a patient from Montana referred to me because of my knowledge of his disease, a rare fungus infection,” Tucker recalls. “At the time there were no effective drugs on the market, but there were some experimental drugs.”

Tucker, who had participated in clinical research while doing an Infectious Diseases Fellowship at Stanford University, discovered a study for a drug to treat the fungus infection. “I enrolled in the study mainly to provide care for this one patient,” says Tucker. “The Research Department here really grew from taking care of a single guy with a hard-to-treat disease.”

Most of the trials conducted in Wenatchee test drugs that are fairly late in the approval process -- called phase three and phase four trials. Phase three are drugs that are about ready to come to market. Phase four drugs are already on the market and need testing against another drug.

“Unlike universities that conduct pure research or early phase trials,” explains Cook, “our studies have been looked at and tested by a lot of different people before we take them. We’re in a small community. Clinical volunteers are our neighbors, our colleagues and our patients, and we’re not going to put them at risk. We look very carefully at the trials th