Looking for Medical Help With a Clinical Trial

A little-noticed provision of the Affordable Care Act could open the door for many patients seeking potentially life-saving treatments.

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.

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.

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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.

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Although many patients seek out a trial when standard treatment fails, clinical trials can be a first-choice treatment option, too. "Many clinical trials test treatments for earlier forms of cancer," Gansler says.

To be eligible for a trial, a patient generally must enroll after diagnosis and before treatment begins—or when standard treatment fails. Not all trials test new treatments on sick patients, however. Some studies aimed at preventing a disease seek healthy participants who may be at risk for a medical condition. Many trials look at new ways to detect, diagnose or understand a disease.

Among the 474 clinical trials ongoing at Hopkins' cancer center, for example, some examine ways to better manage nausea or pain, while several look at various approaches to support patients and their families. Others focus on finding new ways to screen for a disease.

Finding a Perfect Match

But looking for a clinical trial can be daunting—and sometimes unsuccessful. Cynthia Solomon, 66, of Sonoma, Cal., in September searched for a clinical trial for terminal stage 4 ovarian cancer on ClinicalTrials.gov, a service of the National Institutes of Health that lists more than 150,000 publicly and privately funded trials worldwide.

Solomon, a retired business owner, was seeking a trial that was testing a particular type of drug treatment. She says most of the studies she found were outdated or closed. Solomon's doctors at the University of California–San Francisco only knew of trials at the research facilities there. "Doctors rarely bring up clinical trials unless their institution has one to offer, and they are rarely aware of other clinical trials," says Solomon. She gave up searching for a clinical trial and is focusing on her quality of life.

Meanwhile, Sisolak says he only considered a clinical trial after his hematologist called his former professor at Hopkins medical school to ask about possible research studies. The professor knew of the cutting-edge research at the university.

Despite the difficulties in navigating the system, there could well be a trial for you. If your doctor does not know of any, turn to the Internet. A good place to start your search, despite Solomon's disappointment, is ClinicalTrials.gov. A recent search, for example, found that 307 trials for Parkinson's disease were recruiting participants. You can narrow your search by location, age, trial phase and other factors. Another good resource is the nonprofit Center for Information & Study on Clinical Research Participation (www.ciscrp.org).

For cancer trials, look into the American Cancer Society's free Clinical Trials Matching Service at www.cancer.org. At the National Cancer Institute's Web site (www.cancer.gov/clinicaltrials), you can search among the 12,000 trials that are accepting patients, and you can review the results of completed research.

If you've been diagnosed with a specific condition, call its professional advocacy organization. The TrialMatch program at the Alzheimer's Association will try to put patients in touch with studies. Alzheimer's patients and their families also should check out the National Institute on Aging (www.nia.nih.gov/alzheimers/clinical-trials). Among 23 studies in California, researchers are recruiting individuals with early-onset Alzheimer's to test the impact of certain drugs.

Gansler says that many databases will screen for patients’ clinical details. Often, the treatment being studied "is not at all relevant to their type of cancer or the stage of their cancer," he says.

For example, Gansler says, initial human studies of new drugs focus on finding a safe dose and studying side effects. These trials could be a reasonable option for a patient with advanced cancer that has returned after other treatments.If you are accepted into a clinical trial, you will be given "informed consent" documents, which will describe the details of the treatment. Do not enroll until you've read the documents. "Sometimes consent documents can be intimidating, but they spell out the risks and benefits," Haugen says. Ask your doctor to go over these documents with you.

Lansey says patients and their families need to understand the number of visits that will be required, possible side effects, risks and benefits, and what the treatment entails. "Patients and their families are encouraged to ask questions throughout this discussion," Lansey says.

Find out about any out-of-pocket expenses, including lodging and food if you travel for a clinical trial. And, remember, clinical trials are voluntary and you can drop out at any time.

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Contributing Editor, Kiplinger's Retirement Report