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So You're Ready To Be A Guinea Pig


Personal Business: HEALTH

SO YOU'RE READY TO BE A GUINEA PIG

If you or someone close to you suffers from a serious illness, you're probably acutely aware of any reports of new or experimental treatments. But getting access to them is tougher. You can either wait the several years it takes for a new drug to win Food & Drug Administration approval, or you can volunteer for a clinical trial.

When it comes to determining the effects of new drugs in people, there's no substitute for a human guinea pig. Each year, drugmakers and the National Institutes of Health (NIH) conduct thousands of closely monitored human trials of new medicines to determine their effectiveness. And they are constantly looking for test subjects. The National Cancer Institute estimates that only 3% to 5% of U.S. cancer patients sign up for such trials, and other disease studies do no better. "We'd be getting better answers a lot faster if more people enrolled," says Dr. Leonard Zwelling, head of research administration at M.D. Anderson Cancer Center in Houston.

One reason for the low sign-up rate is payment. Insurers often refuse to cover the medical-care costs of experimental treatments, even though drugs in most clinical trials are free. However, many hospitals have case managers who will work with the insurer to increase the chances of coverage.

You don't have to be deathly ill to volunteer. James Dougherty, chief of clinical affairs at Memorial Sloan-Kettering Cancer Center in New York, says: "The appropriate time to enroll is early in the disease." At that point, a test may even shorten treatment time. Recent trials of a colon-cancer drug, for example, found that only six months of follow-up chemotherapy were needed after surgery, vs. the standard 12 months.

Most trials are conducted at highly regarded teaching hospitals. To qualify, participants must be closely matched in terms of disease stage, overall health, and sometimes, age and gender. Enrollees must sign an informed-consent form that explains the procedures and potential benefits and risks.

Three types of trials need volunteers: limited Phase Ones that test a drug for safety, larger Phase Twos that examine efficacy and best dosage, and huge Phase Threes that measure a drug or procedure against the best standard treatment. Studies are also conducted after drugs are approved to determine their effectiveness for other uses.CAVEAT. In Phase Two and Three trials, be forewarned that participants don't necessarily get the drug under study. Patients are randomly divided into two groups: One gets the new drug, the other the best conventional treatment. Neither patient nor researchers are told who gets what.

Patient advocates sometimes criticize such randomized, double-blind trials because some participants are denied a therapy researchers expect to prove more effective. But the NIH will end a trial early if a new treatment shows a major benefit--or dangerous side effects. A six-year trial to determine if a standard breast-cancer treatment, tamoxifen, can prevent the disease in high-risk women was just halted two years early by the the National Cancer Institute because data in favor of the drug were so strong.

If you're interested in participating in a clinical trial, ask your doctor or call the hospital that is administering the program. The NIH offers information on clinical trials at 800 411-1222, as does the National Cancer Institute at 800 4-CANCER. You can also check out several Web sites: cancernet.nci.nih.gov; www. centerwatch.com, a privately run site; and www.clinicaltrials.org, run by M.D. Anderson Cancer Center. Your efforts could literally be a life-saver.EDITED BY AMY DUNKINReturn to top

TABLE

Hierarchy of Clinical Trials

PHASE ONE

Tests a new drug's safety in the human body. A small number of healthy volunteers are usually paid to participate.PHASE TWO

Tests for efficacy in several hundred patients. There can be two groups, one of which receives the standard treatment or a placebo.PHASE THREE

Studies of as many as several thousand patients. This is the last step before a pharmaceutical company can request FDA approval.POST-MARKETING

These trials come after FDA approval. They compare the drug with other drugs, monitor effectiveness, or see if it works on other illnesses.Return to top


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