Understanding Clinical Trials
by Bonnie Jacob

Clinical trials offer patients the chance to test new medical therapies before they go on the market. Depending on your condition, it's possible a trial could be just what the doctor ordered.

"Clinical trials are one of the many health-care options that an informed consumer should know about," says Ken Getz, president and publisher of CenterWatch, an information resource headquartered in Boston.

Each year, medical researchers conduct more than 100,000 clinical trials at about 50,000 U.S. locations. Pharmaceutical companies and other manufacturers fund two-thirds of the trials; government agencies, such as the National Institutes of Health, sponsor most of the rest.

REAL PEOPLE, REAL HOPE

For many people, a clinical trial provides access to the newest and most advanced therapy. For people with life-threatening conditions who have exhausted all other options, a clinical trial may be the last and best hope. Even if your condition is not life threatening, a trial might provide access to a treatment that's more effective or has fewer side effects.

To learn about a clinical trial that might be right for you, start by asking your doctor or case-management nurse, Getz advises. You can also check www.centerwatch.com, which lists more than 40,000 current trials. And researchers often advertise for volunteers in local newspapers and HMO newsletters.

WHAT TO EXPECT

Before being accepted into a trial, you'll be interviewed to determine if you meet its criteria, which are established to make sure you're an appropriate candidate and that you can participate safely. If you enter the trial, you'll be asked to sign an agreement that you'll follow the trial's protocols, including taking the treatment as prescribed, keeping all scheduled office visits and answering all of the investigators' questions accurately.

In most trials, participants are divided into two groups. One group receives the treatment being tested; the other receives the current standard of care. Researchers can then compare which group does better.

In some trials, one group receives an inactive medication called a placebo. During the trial, you'll receive the treatment from the researcher, who's known as the principal investigator. If you're testing a new medication, you may be able to take it at home, but you'll probably need to receive follow-up exams at the principal investigator's office.

During the trial, you'll also remain under the care of your primary-care physician, who will provide all care not covered in the trial. Some volunteers are paid to participate in clinical trials. But even if you're not, in most cases, trial-related medication and treatment will be free.

"Benefits of participating in a clinical trial have more to do with health than money," says Getz. "You could be gaining access to a treatment you couldn't get otherwise," he says. "And by advancing medical knowledge, you're helping others who have the condition."

Bonnie Jacob spoke with Ken Getz, president and publisher of CenterWatch, an information resource headquartered in Boston.

Vitality magazine, April 2001 Self-Health supplement