Patients seeking to participate in a clinical trial often face an obstacle: Their health insurer could limit their coverage when they enter the experimental treatment program. That's about to end. Starting January 1, a little-noticed provision of the Affordable Care Act bans insurers from denying routine medical services to clinical trial participants—and that could open the door for many patients seeking potentially life-saving treatments for cancer, heart disease and other serious medical conditions.
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But many of these patients are likely to run into another barrier: Chances are, they'll be on their own navigating the maze of thousands of government, academic and private research experiments. Many patients may not even know that a clinical trial is an option, says Dr. Ted Gansler, director of medical content for the American Cancer Society.
Gansler says that he expects the new health care law will raise awareness of clinical trials. The law was intended "to remove an obstacle for patients" to participate in clinical trials, he says.
A clinical trial helps determine whether drugs, medical devices, and new therapies and vaccines that hold promise in the laboratory are safe and effective for humans. Some trials examine whether already approved drugs can be effectively used for other diseases or work better when combined with other treatments. Still other clinical trials test new surgeries or therapies that could prevent disease or a recurrence of illness.
Retired engineer M. Dennis Sisolak, 72, of Bel Air, Md., entered a 15-month clinical trial at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital in 2008, a year after being diagnosed with advanced kidney cancer. Standard treatment had failed to halt the cancer's progression.
Sisolak's trial tested an immunotherapy drug—one designed to get rid of the cancer rather than slow its spread. "I'm feeling great," says Sisolak, who has had clean scans. "There is no cancer. I haven't taken any cancer meds for two years."
Not everyone sees such positive results. Treatments tested in clinical trials may result in outcomes no better than established treatments. In some cases, tested treatments can worsen the illness and even result in death. Adverse reactions and unpleasant side effects also are possible.
Depending on the needs of the researchers, you can enter a trial at one of three phases. Phase I trials have typically 15 to 30 patients and determine safe doses and side effects. A Phase II trial includes about 100 patients and helps determine how well a drug or treatment works and whether it is safe. In Phase III trials, a drug or treatment is given to several hundred to several thousand participants to confirm its effectiveness compared with the current standard treatments.
Several obstacles have discouraged patients from participating. For one thing, doctors typically don't discuss a clinical trial with patients as a treatment option. Also, many patients who enter trials face significant out-of-pocket costs. The researchers pay for such expenses as the drugs, medical devices and treatments that are being tested. But insurance companies often deny coverage for routine services related to the trial, such as temporary hospitalization or monitoring. The new health care law requires insurers to pay for these costs. Medicare already covers routine costs related to most government-sponsored trials.
Moreover, several myths discourage participation, experts say. One is that a patient in a Phase III trial will receive only a placebo if they are placed in a control group, which is made up of patients who do not get the experimental treatment. "You will never get inferior care," says Patricia Haugen, a breast cancer survivor, former clinical trial patient and consumer advocate in Sioux Falls, S.D. Patients on the placebo receive the current standard treatment, Haugen says.
Another fallacy: Clinical trials are a last-resort option. "That misunderstanding can prevent a patient from getting the benefit of a new treatment," says Dina Lansey, a registered nurse and clinical research recruitment specialist at Hopkins' Kimmel cancer center, in Baltimore, Md.