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Patients key to advancing cancer treatment through clinical research
A 2008 study in the Journal of Clinical Oncology showed that when patients were asked to participate in a cancer research study, 75% agreed. And yet nationwide, only 3% to 5% of adult cancer patients participate in clinical trials. Clinical trials are essential to the discovery of new cancer treatments. So why do so few patients participate? We talked with Maha Hussain, M.D., former-associate director of clinical research at the University of Michigan Rogel Cancer Center, to learn more..
Q: Can you explain what a clinical trial is?
A: A clinical trial is a research study in which patients partner with physicians to find better ways to improve cancer treatment or outcomes. Each trial attempts to answer a scientific question relevant to the care of the patient. Broadly speaking, studies seek better ways to prevent cancer, to diagnose cancer early, to treat it better, or to improve quality of life by reducing pain and other cancer-related symptoms.
Q: Why should a patient participate in a clinical trial?
A: There are many situations where there is no standard treatment available or it doesn't work well. Unless there's a partnership between doctors and patients, the status quo of poor outcomes will continue forever. Curing testicular cancer in younger men is now possible because patients were part of early phase clinical trials that showed certain drugs worked well. This is also true for breast cancer and several other adult and childhood malignancies. Unless we investigate new treatments in clinical trials, there will not be better treatment.
Q: Why don't more patients participate?
A: There are several factors, including the availability of clinical trials where patients are getting their cancer care as well as the willingness of a patient's physician to offer a clinical trial as part of the overall care. Patients may have concerns about the toxicity or cost of participating in a research study. Also, some people are worried that they may be used as guinea pigs. That is certainly not the case. Patients are equal partners in the whole process.
Who should consider a clinical trial?
The best time to consider a clinical trial is when you are newly diagnosed or when there's a change in your cancer -- for example, if it has spread or recurred. Each trial has strict eligibility criteria. Talk with your doctor to find out whether any studies are available to you or call the Cancer AnswerLine at 800-865-1125.
Q: Can a patient quit a study?
A: Absolutely. If a patient at some point feels uncomfortable about continuing for any reason, they have the right to withdraw with no questions asked. Furthermore, even if a patient wants to stay in a study, if his or her doctor determines that it isn't safe, the doctor can remove them from the trial.
Q: Are placebos, or sugar pills, used in cancer clinical trials?
A: First, let me debunk a myth: We never deny patients treatment for their cancer. All of our clinical trials are grounded in science that leads us to believe that the experimental therapies we are testing in clinical trials may work. In the vast majority of trials, placebos would not be used alone in a situation where we already have a treatment that is proven to help a patient. A placebo may be used if doctors are evaluating whether adding a new drug to a standard treatment would work better that the standard treatment alone. Sometimes patients who receive placebos may be offered the study drug later in the trial if it appears that the drug is helpful. In any case, doctors must inform patients about available treatments and will not delay treatment. Ultimately, it's up to the patient to decide whether participating in a research study is right for her or him.
Q: Will health insurance cover the costs of clinical trials?
A: The costs of procedures that are part of standard cancer care are generally covered by insurance. Procedures that are for research only -- for example, a blood test to assess the effects of an experimental drug -- may not be covered. Often, researchers can find funds to cover these costs for patients. The informed-consent form will fully outline what types of costs patients may have to bear if they participate.
Q: Will a patient enrolled in a clinical trial get better care than someone who isn't enrolled?
A: Although there are not specific studies for every situation, we all agree as physicians that in diseases where there are no effective treatments or cures, clinical trials offer hope. In my opinion -- and many experts share my assessment -- patients will get better care on a clinical trial.
Q: How do you balance hope while providing patients with realistic expectations?
A: Clinical trials are well thought out. There's always a fair amount of science behind a clinical trial that suggests that the question being studied is legitimate and that there is a reasonable chance that something valuable will come out of it. We don't do anything without a burden of information that gives us confidence. Obviously, there is no guarantee of benefit. But it's like playing the lottery: You don't win if you don't buy a ticket.
Visit our Clinical Trials web pages for more information.
Read the Summer, 2010 issue of Thrive.