Subject Yourself to a Study?

Armed with information gained from the Internet and elsewhere, more patients than ever are referring themselves to clinical trials and tests of experimental drugs. That’s a change from a time when most patients relied on their doctors to get into research studies.

They are joining trials of experimental cancer drugs, new therapies to relieve arthritis pain and new treatments for depression.

If you have a long-standing and solid relationship with a primary care doctor, he or she can advise you on the pluses and minuses of joining a clinical trial.

But in these days of turmoil in health care, some patients don’t have that kind of relationship. People who change jobs or whose employers switch medical insurers may be shifted to new health plans and doctors. That can require taking charge of your own health care.

“Often I ask, who is your doctor, and patients say ‘I don’t know,’ ” or they give the name of the health insurer, said Dr. John I. Gallin, who runs the National Institutes of Health clinical center in Bethesda, Md., a 300-bed hospital that runs more than 900 treatment trials annually.

Just as the personal link between doctors and patients has become frayed, patients themselves “are becoming much smarter” by seeking out medical information on the Internet, he said.

Patients must remember that a trial is just what it says, a test of something that hasn’t been conclusively proved to be medically beneficial. And because the drug is unproven, the tests carry some risk.

Take the hypothetical example of a cancer patient given only a few months to live by his doctor. He learns of a compound tested in animals that arrests the cancer but that often results in major liver damage. Here the risk is probably worth taking.

Take another example of an obese person who is considering a new diet drug. It’s been tested on 50 people, one of whom died during the trial. It’s not clear, however, if the drug had something to do with the death. But the obese person is otherwise healthy. He will likely say, “That drug might help me, but it’s not worth the risk.”

Check Out Group Running the Trial

Medical trials are promoted on the radio, listed in the newspapers, posted on the Internet, announced through hospitals and doctor’s offices. Consumers thinking about signing up should be sure a reputable sponsor is running the trial: an academic medical center like one of the University of California medical schools, or the USC medical school; an institution such as Cedars-Sinai Medical Center; a health plan such as Kaiser or one of the Blue Cross or Blue Shield plans; a government facility operated by the Department of Defense or the Department of Veterans Affairs; or a program run by the National Cancer Institute or another of the federal National Institutes of Health. There also are cooperative oncology groups, in which medical institutions work together on cancer treatment trials.

There are private trials, but they may not have the safeguards and strict procedures required by university or government groups, warned Dr. Joe Toupin, chief medical officer for the UC system.

Universities and hospitals have institutional review boards that are required to follow strict standards designed to protect patients in drug trials, said Dr. Charles M. Cutler, chief medical officer for the American Assn. of Health Plans, a Washington, D.C.-based trade group for HMOs.

Before joining a trial, prospective patients should read consent forms carefully. An individual must understand the goals of the trial, the treatments, the risks and side effects. Also, considering that 80% of experimental drugs being tested for the first time on humans won’t work, patients should not set their expectations too high, advised Dr. Joseph Carver, senior medical director for Aetna U.S. Healthcare, the nation’s biggest health insurer.

Not everyone with a disease can qualify for a trial dealing with the particular condition. The research study, for example, might be limited to people between ages 40 and 65 who have a family history of the disease. But a determined person may be able to find some relevant study among the thousands conducted each year.

Study Won’t Conflict With Regular Care

More tests are available in places with large concentrations of medical centers, such as Boston, New York and Los Angeles. But regional oncology cooperatives mean cancer treatment trials are widespread. And the National Institutes of Health clinical center is a national hospital. Anyone who qualifies for one of the trials will be cared for at the NIH center free of charge.

If you join a medical trial and have health insurance, your policy will continue paying for all of your regular care. You won’t need your health plan’s permission to join a trial, Toupin said, and your participation won’t jeopardize your coverage. “But if you have a regular physician,” he advised, “you want to keep that person informed.”

Health insurers will not pay for procedures considered experimental. In a clinical or experimental trial, the new treatments and drugs are free; all costs are borne by the institution sponsoring the trial.

Aetna U.S. Healthcare encourages the use of clinical trials. Only 3% to 5% of U.S. cancer patients enter clinical trials, a low percentage that is “astoundingly horrible,” Carver said. “There have been an unbelievable number of barriers built up over the years.” Doctors too often have been reluctant to encourage their patients to enroll, and patients have been fearful that they would be guinea pigs, he said.

But the reality is that a patient participating in a clinical trial will get the best conventional care available for his ailment, plus whatever compound, drug or technique is under investigation. Study participants typically are more closely observed than they would be under ordinary circumstances in a doctor’s office. “Some patients are disappointed when the study is over because they cannot check into a hospital every three months for a full battery of tests and observations,” said the NIH’s Gallin.

While comparatively few adults with cancer are in trials, the majority of children with the disease have been enrolled, Gallin said. Pediatric oncologists--cancer specialists for children--often are affiliated with teaching hospitals and have long been enthusiastic supporters of clinical trials. As a result, childhood cure rates for cancer are making dramatic progress.

Be Aggressive in Cancer Treatment

Adults, Carver said, should take the same aggressive approach to cancer for themselves as they would for their kids.

The patient recruitment line for the National Institutes of Health is (800) 411-1222. The National Cancer Institute line is (800) 422-6237.

Information on AIDS trials is available at (800) 874-2572.

On the Web, a one-stop shopping center for information on clinical trials is https://www.nih.gov/health/trials.

Some Web sites with information about clinical trial include:

* AIDS: https://www.actis.org/actis.asp.

* Allergies and infectious diseases: https://www.niaid.nih.gov/clintrials.

* Alzheimer’s disease: https://www.alzheimers.org/trials/index.html.

* Cancer: https://cancertrials.nci.nih.gov.

* Eye diseases: https://www.nei.nih.gov/neitrials/inde.htm.

* General clinical studies: https://clinicalstudies.info.nih.gov/.

* Heart, lung and blood: https://www.nhlbi.nih.gov/guidelines/index.htm.

* Rare diseases: https://rarediseases.info.nih.gov/ord/research-ct.html.

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