Patients have many questions about clinical trials, and understandably so. This section addresses some of the most common questions around who can participate in clinical trials, insurance coverage, how to identify trials for which you may be eligible, and more.
When should I consider participating in a clinical trial?
Although many people think of clinical trials as an option only when all other treatments have failed, clinicians recommend finding out about clinical trials as early as possible in treatment, to have a better understanding of all your treatment choices.
Are clinical trials a last resort?
The idea of clinical trials as a last resort is a common misconception. In 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 people think of clinical trials as an option for treatment only after other treatments have failed. There are a lot of trials for patients 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.
Will my doctor tell me if I'm eligible for a clinical trial?
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. You can look for a trial with our Clinical Trial finder.
What if I'm ineligible for a clinical trial? What other options are available?
Under certain circumstances someone might be able to obtain experimental treatments, also called investigational new drugs, if they cannot participate in a clinical trial. The Food and Drug Administration allows manufacturers of investigational new drugs to provide the agents to someone with a serious disease who might benefit from the treatment under what is called “expanded access.” Also, someone might be ineligible for one trial, but be eligible for another one.
Do clinical trial patients get a placebo instead of actual treatment?
Absolutely not. Clinical trial participants 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.
Do I need to be near a big hospital to take part in a cancer clinical trial?
Not necessarily. A major institution may be a coordinator of a clinical trial but under its auspices may have local physicians and community hospitals working with patients, too. Many cancer clinical trials take place at local hospitals. Some also take place at local cancer clinics and doctor’s offices.
Does insurance cover the costs of clinical trials?
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.
Does Medicare cover the costs of cancer clinical trials?
Medicare has been covering patient care costs of clinical trials since June 2000.
Are patients told the risks that might come with participating in a trial?
All eligible participants 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 person 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.
May I leave a clinical trial?
Yes. You have the right to leave a cancer clinical trial at any time for any reason, without giving up access to other treatment, but you should inform the research team about doing so and why.
Why don't more patients participate in clinical trials?
Patients may not consider clinical trials because they…
- Don’t know about clinical trials
- Don’t know how to find trials
- Are afraid or suspicious of research
- Have practical or personal obstacles
- Feel like they can’t afford to participate
- Don’t want to go against their doctor’s wishes
- Believe that if they participate they may not get any other treatment
In addition, doctors themselves can be more helpful in encouraging patients to consider clinical trials. Many doctors …
- Don’t know about clinical trials
- Are unwilling to “lose control” of a patient’s care
- Believe that standard therapy alone is best
- Are concerned that clinical trials add administrative burdens
- Are concerned about how their patient will react to the suggestion of a clinical trial
Does informed consent protect the patient, or does it only protect researchers and doctors?
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.
What does a randomization in a clinical trial mean?
Randomization is a term meaning that when someone is in a clinical trial, there is an equal likelihood that they will be given the experimental or the standard treatment. Besides randomization, a clinical trial is usually blinded, meaning that neither the participant nor the doctor treating you knows who is getting which treatment so the results of the trial are unbiased.
Can I participate in a clinical trial that does not study a new treatment?
Clinical trials often test treatments, but they also study new diagnostics, screening methods, prevention measures and quality of life improvements, such as ways to reduce side effects of treatment.