In the next few weeks, 300 volunteers in the Baltimore-Washington area are going to be enlisted to take an experimental AIDS vaccine, part of the vaccine's first large-scale human test, which began Tuesday across the country.
That's just one clinical trial at Johns Hopkins Medical Institutions. Right now, there are 362 clinical trials of medicines, therapies or products taking place there. At the University of Maryland Medical Center, 201 trials are under way. And that's just at two medical centers in the Baltimore area.
Thousands of people are constantly needed for area clinical trials, but why should they risk taking an experimental drug or make a lifestyle change?
Sometimes, it's to try to save themselves from a dreaded disease. Jeanne Charleston, project director for Johns Hopkins Pro Health, is conducting one of the largest multisite trials in the United States, the Diabetes Prevention Program. She expects 200 people in the Baltimore area to participate because "they have relatives with diabetes, and they're willing to do almost anything if they could prevent themselves from getting diabetes."
Sometimes, clinical trials hold out the only hope. Perhaps the best example is the clinical trial carried out with the drug AZT in 1985-1986. When researchers realized that only one of the 300 participants on AZT had died but 19 taking the placebo had died, the study was stopped. Eventually, more than 4,000 people would receive AZT under new-treatment protocols before the drug would be approved as Retrovir in 1987.
Free food might be a reason to enroll in a Hopkins trial that aims to find out whether certain diets can prevent high blood pressure. Participants who are at risk for hypertension receive all of the food they will eat for 14 weeks, plus $200. To ensure compliance with the diet, though, participants must eat at least one meal a day with the staff.
People are enrolled in studies two primary ways: Either they're recruited, perhaps through newspaper ads and fliers, or they are referred by their physician. Information on various trials usually is found through the research institutions themselves or groups associated with a particular disease. The National Cancer Institute, for example, lists information on the Web at http://cancertrials.nci.nih .gov.
Risks of side effects vary from trial to trial. There is little risk in the dietary trial, but a kidney-disease-prevention trial at Hopkins requires the injection of a small amount of a radioactive isotope, a minor risk but still a risk. Immunization trials often carry greater risks.
Examining the risks falls to the institutional review board, or IRB, at any institution doing research. The IRB is made up of physicians, lay people and community representatives. They review the ethical appropriateness of every study, making sure that they don't place undue risk on participants and that they aren't prevented from receiving standard therapy that does work.
"Say you have heart disease," says Dr. Barry Meisenberg, deputy director of Greenebaum Cancer Center at the University of Maryland, "and I say, 'I want to try a new drug.' If the appropriate treatment is angioplasty, the IRB will say, 'Wait a minute, you can use this drug only if angioplasty fails.' "
No clinical studies can be done without IRB approval. Periodically, the FDA inspects all IRB records. The National Institutes of Health oversees IRBs, too.
One of the responsibilities of the IRB is to ensure that everyone consents to participation. Since 1981, the FDA has required written informed consent for all studies that involve any product that would be regulated by the FDA.
Consent is vital not just at the beginning but for every step of a trial, says Ruth Jordan, a senior vice president with Matthews Media Group, which develops educational materials to attract patients to clinical trials.
Understanding the duration of the trial is part of that consent, for if a patient drops out part-way through, a great deal of data is rendered useless. And trials can be long: The diabetes trial will take six years, the kidney trial five.
A SAMPLING OF TRIALS:
* Hopkins is studying a vaccine to fight the sexually transmitted human papilloma virus, which causes cervical cancer in women. Needed: 48 healthy men and women between ages 18 and 29 who have no previous history of HPV. The women should have had no abnormal pap smears. Information: 410-955-4055.
* UM will enroll 200 women to study the effects of hormone replacement therapy on uterine fibroids. The women must be at least 45, have reached menopause, have been diagnosed with fibroids and have their own physician. 410-706-5563.
* Hopkins is studying the efficacy of Luvox (fluvoxamine) to treat children and adolescents with anxiety problems. Needed: 60 children who are afraid to go to school, reluctant to separate from their parents or who worry excessively about bad things happening to them. 410-614-4460.
* UM Greenebaum Cancer Center is starting a study of high-dose chemotherapy combined with a stem-cell transplant for men with advanced prostate cancer that is resistant to hormonal therapy. 410-328-1299.
* Greenebaum is also recruiting women with advanced breast cancer for a study of the drug herceptin combined with another drug, IL-2, that boosts the immune system. 410-328-7904.
* Hopkins is studying the drug Effexor (venlafaxine) to determine how well it helps children and adolescents who have major depression. The 15 participants must be between 6 and 17, and they will be screened for certain criteria. 410-614-4460.
Before you enroll
The Matthews Media group prepares materials that educate the public about clinical trials. Ruth Jordan, senior vice president, offers points that everyone enrolling in a trial should consider:
* Make sure you are willing to enroll even though you may be in the group receiving a placebo.
* Be assured that all clinical trials involving humans are monitored by the National Institutes of Health.
* Know how the study will affect your daily life and for how long.
* Make sure you have enough time to read and discuss with your doctor and family the "informed consent" form before you sign.
* Find out what costs you will be expected to bear, such as for food or travel.
Pub Date: 6/28/98