Misconception: Cancer clinical trial patients are given a placebo instead of actual treatment.
Fact: Not true. Women who join clinical trials are either given the “standard of care,” which is the best treatment available for her type of ovarian cancer, or receive the new treatment that is being tested. Placebos may be used in situations where the new treatment being tested is an “add on” to the standard of care or if there is no standard of care.
For example, there are clinical trials that look at whether extra chemotherapy after the standard first-line course of treatment improves women’s health. In this kind of trial, a placebo would be used, but all women receive the best treatment available first. In addition to that standard treatment, some women would receive placebos and others would get additional chemotherapy.
Misconception: Insurance does not cover the costs associated with clinical trials.
Fact: Unfortunately, not all insurance companies cover the patient care costs, such as costs for additional medical tests associated with clinical trials, but many do. What is covered varies by health plan and by study. Under the Affordable Care Act, insurers are prohibited from dropping or limiting coverage because you choose to participate in a clinical trial. If you find a trial in which you want to participate, ask your doctor or the office’s research nurse to help you determine what your insurance covers. In many studies, the costs not covered by insurance will be paid by the study. (Note that extra costs associated with travel to additional appointments or daycare are typically not covered, but are in some cases.)
For example, all clinical trials that are conducted at the National Cancer Institute’s (NCI) campus in Bethesda, MD, provide reimbursement for travel from anywhere in the United States for participating patients. More information about insurance coverage can be found in the NCI’s resource, Clinical Trials and Insurance Coverage: A Resource Guide.
Misconception: Medicare does not cover the patient care costs of cancer clinical trials.
Fact: Medicare has been covering these costs since June 2000.
Misconception: You need to be near a big hospital to take part in a cancer clinical trial.
Fact: Many cancer clinical trials take place at local hospitals. Some also take place at local cancer clinics and doctor’s offices.
Misconception: Once I sign the consent form, I have to stay enrolled.
Fact: You also have the right to leave a cancer clinical trial at any time for any reason, without giving up access to other treatment.
Misconception: Clinical trials are a last resort for patients.
Fact: A woman may be eligible for a clinical trial at any point in her experience with ovarian cancer – during front line therapy, recurrence and even survivorship. Many women think of clinical trials as an option for the treatment of their cancer only after other treatments have failed them. There are a lot of trials for women in this situation, but many other trials are available.
For example, trials are conducted for women who have not yet had surgery. This type of trial might try to find better ways to diagnose ovarian cancer. There are also clinical trials for women who have just finished their first treatment. These trials may test ways to prevent or delay recurrence. In addition, women who do not have ovarian cancer, but may be at high risk because of a family history of the disease, can also take part in trials focused on ways to prevent it.
Misconception: Informed consent only protects researchers and doctors, not patients.
Fact: Informed consent is a full explanation of the trial that explains the voluntariness, possible risks, benefits, and privacy protections involved with participation. Informed consent does not require you to give up your right to protection if the medical team is negligent or does something wrong.
Misconception: If my doctor did not mention a clinical trial, then it is not for me.
Reality: Unfortunately, many physicians do not know about clinical trials that may be available to their patients or they may be concerned about how their patients will react if they bring up clinical trials. It is up to you to ask about trials if your doctor did not mention them. There may not be appropriate clinical trials for you, but it does no harm to explore the options with your doctor, just as you would ask about other aspects of your care.
Misconception: Patients are not always told all the risks that might come with participating in the trial.
Reality: All women must be able to provide “informed consent” before they decide to participate in a clinical trial. This is your right as a clinical trial participant. Before you give your consent, you will be told all the facts about the study including any risks and benefits that might be experienced.
Some trials may present more risks than others and each woman should consider the risks and discuss them with her doctor before making a decision to participate. In addition, if new risks or side effects come up as more women enroll in the study, you will be informed of this as well. You can leave the study at any time if you feel it is no longer in your best interest to participate.
For more information about clinical trials, please visit learnaboutclinicaltrials.org