PERSONAL HEALTH : Clinical Trials--Free Help for the Asking
When you’ve tried every treatment on the market for what ails you--and you’re still ailing--what’s left?
Perhaps a clinical trial.
These closely supervised investigations evaluate new medical treatments for maladies, ranging from headaches to AIDS. At any time, hundreds of thousands of people participate in such trials worldwide, says Maria Lebron, managing editor of the Online Journal of Current Clinical Trials in Washington, D.C. (More specific statistics are difficult, she adds, because there is no international registry.)
People participate mostly to relieve their symptoms, but some mention the altruistic motivation of contributing to science. Other draws: free medical care and, for some, a chance to pocket some cash in exchange for being poked and prodded.
The Stereotypes
“Some people worry that they’re going to be experimented on,” says Dr. Thomas Kovacs, UCLA associate professor of medicine and director of the Center for Ulcer Research and Education (CURE) Peptic Ulcer Clinic at the Veterans Administration Medical Center, West Los Angeles.
To reverse what he calls “the guinea pig notion,” Kovacs tells potential subjects: Most medications under study have already been used extensively in other countries; many have already been proven effective in previous trials. If symptoms don’t improve, participants can be taken off the medication and another treatment prescribed.
The Rules
A good clinical trial, Kovacs tells participants, is one in which subjects are randomly assigned to treatment groups without the doctor or patients knowing which treatment they are getting (in trial jargon, “randomized and double-blinded”). Often, Kovacs says, a trial needs to have a placebo group, especially when studying a problem like ulcers, which tend to disappear and recur spontaneously.
Trials can take a few weeks to a few years. For ulcer medicine studies, the typical length is 8 to 12 weeks for the “acute” phase, Kovacs says, and much longer for a study investigating maintenance medicine.
Protocols can be rigid. Some trials require that people quit taking medication for a specific period before the study, and rule out those with chronic health problems such as heart disease.
Not all volunteers make the grade. “For one smoking-cessation study, we screened 1,500 people to get 200 subjects,” recalls Nina Schneider, UCLA associate research psychologist and chief of nicotine research at the Veterans Administration Medical Center.
Trials must be approved by a committee on human studies. Participants must read and sign a lengthy consent form that outlines the number of visits required, potential side effects and other details.
The Drawbacks
The consent form spells out worst-case scenarios. For instance, a study of medications to relieve acute erosive esophagitis warns that the sedative used before a tube is placed down the throat may cause vomiting, breathing problems or dizziness, among other problems. The spray to numb the back of the throat can slow the heartbeat and make blood pressure drop. The tube could perforate the stomach. One of the medicines studied could cause diarrhea, rash, headache and abdominal pain.
The Progress
Today, many trials tend to be large, studying 1,000 patients or more, says Dr. Richard Ungerleider, chief of the clinical investigations branch of the National Cancer Institute, Bethesda.
Patient Opinions
Enrique Cabrera of Los Angeles is a veteran subject. A long-term ulcer patient, he is now enrolled in a maintenance study at the UCLA’s CURE clinic. Although he doesn’t know if he is taking anti-ulcer medicine or placebo, his last exam found that the ulcer is completely healed.
His advice to others who don’t feel better with medicine that’s on the market? Give trials a try.
Some patients say they take better care of themselves while enrolled in a trial. “Just the act of coming to a (research) lab will help them,” says Schneider of some cigarette-smoking patients trying to quit. “It’s like going to a gym instead of (trying to) exercise at home.”
Hooking Up
Some patients are referred to trials by physicians or by friends who have participated. Some patients call the study center directly, alerted by advertisements.
Join one study at a time, Kovacs sometimes reminds patients, who have been known to double dip. “People have tried coming here and USC to work on the same ulcer,” he says.
Many clinical trials, but not all, are conducted at universities or metropolitan hospitals. “Many private practice physicians take part in clinical trials,” notes the NCI’s Ungerleider, “so it is often possible to stay in the community and take part in clinical trials.”
Following Up
Participants are often required to return to the study center for frequent follow-up, but the investment of time is clearly spelled out in the consent form. Sometimes patients must keep a detailed diary.
The Upside
Medical care during a clinical trial is free. Some participants are reimbursed for their time and expenses. For instance, during an ulcer medicine trial requiring endoscopy, in which a flexible viewing tube is passed through the mouth into the intestines, a subject might pocket $400 or so during the course of the study, Kovacs says, in exchange for his or her time and discomfort.
Subjects might see more of the doctor running the clinical trial than they would their own. “We tend to have more time to spend with patients,” says Kovacs of UCLA. “In a busy practitioner’s office, there is sometimes not very much time for patient education.”
The Souvenir Seekers
Some subjects really get into the swing of science. During a recent UCLA ulcer medication study, recall Robyn Altman and Melissa Thronson, research coordinators, a few subjects asked if they could invite their significant others to watch while they underwent endoscopy. “If significant others want to come in and see their (partner’s) insides,” Thronson says, they try to oblige.
They even gave one subject, who requested it, a souvenir full-color print of the ulcer, as seen through the endoscope, suitable for framing.
To Participate
For information on cancer clinical trials, call 800-4-CANCER; for information on ulcer studies, call CURE at (310) 312-9283.
