You’ve probably heard various things about clinical studies—some true, some false—that may impact your decision about whether to participate. Here are some myths and facts to consider.
MYTH: Clinical studies are not safe. I’d be gambling with my health if I signed up.
FACT: Many measures are in place to protect the safety of people who take part in studies—from careful study design to oversight by institutional review boards and periodic monitoring of study data by independent experts. Clinical study participants receive regular and careful medical attention and are closely observed for safety concerns. During the study, researchers must inform you of any new risks, benefits, or side effects they discover. By taking part in a Phase III clinical study, you have the chance to try a new treatment that is generally not available outside of a clinical study. If the treatment is better than standard therapy, as a clinical study participant you may be among the first to benefit from it. Read more about participant safety and clinical study phases.
MYTH: I should agree to take part in a clinical study only if my cancer is terminal or there are no other treatment options available outside a study.
FACT: Some clinical studies are reserved for cancer patients who have exhausted all the treatment options for their disease, but studies are open to patients in other situations too. There are clinical studies that look at methods to prevent cancer in people at high risk. Some studies focus on ways to detect and diagnose cancer. Other studies focus on preventing recurrence in patients whose cancer is in remission. And other studies focus on treatment of patients with advanced cancer or on the quality of life of cancer patients and survivors. Read more about the various types of clinical studies.
MYTH: My health insurance won’t pay for treatment provided through a clinical study.
FACT: Many people don’t even consider a clinical study because they are afraid that their health insurance company will not cover the treatment. In fact, your health insurance may pay for treatment. The majority of patients in clinical studies do receive at least some reimbursement from their health insurance, but health insurance may not pay all the costs. Most often, the study itself will pay for the study therapy and insurance companies will pay for the routine care procedures. You can ask Seattle Cancer Care Alliance (SCCA) staff and your insurance company in advance for help determining which costs are likely to be covered. Read more about health insurance and clinical studies.
MYTH: In a clinical study cancer patients may be given therapy known to be ineffective.
FACT: Placebos, which do not contain any known active ingredient, are used in research to control for the placebo effect—the expectation that an intervention will work. A placebo may not be used in a study as a comparison or control if it would mean putting people at risk by denying them effective therapy. This is particularly true for serious illnesses, such as cancer, where placebos are rarely used. A placebo may be used in a study to test drugs that might prevent cancer, but the people enrolled in such a study would not have cancer. If a placebo is used by itself in another type of cancer study, it is used because no standard treatment exists. In this case, the study would compare the effects of a new treatment with the effects of a placebo. More often studies compare a standard treatment plus a placebo with the same standard treatment plus an investigational treatment. You can find out in advance if a study you are considering might involve a placebo.
MYTH: I will receive poorer or better medical treatment in a clinical study.
FACT: Whether you decide to participate in a clinical study or not, through SCCA you will receive the same high quality of care from some of the world’s leading cancer specialists. People in clinical studies are monitored very closely, which can be reassuring. In Phase III clinical studies, participants receive either the standard treatment or an investigational treatment that researchers have reason to believe is better than the standard treatment. In a randomized study (nearly all Phase III studies) researchers cannot guarantee which treatment you will receive, and they cannot guarantee outcomes. If one treatment arm in a study is proven to be significantly more effective during the course of the study, the participants may all be moved to that arm of the study.
MYTH: If I join a clinical study, I won’t be able to drop out without jeopardizing the quality of my treatment.
FACT: You may quit a clinical study for any reason at any time. The quality of care you receive through SCCA will not be affected by your decision to participate in or withdraw from a study. If you decide to withdraw, your medical team may ask to continue monitoring you for a period of time to assess any long-term effects of the treatment you received in the study.
MYTH: Researchers do not want to enroll older cancer patients.
FACT: Older patients are underrepresented in clinical studies but not because researchers don’t want to sign them up. People age 65 or older make up 54 percent of people with new cancer diagnoses but only about one-third of adult participants (people age 30 or older) in cancer clinical studies. It’s important to test interventions in a wide variety of people because they can work differently in people of different ages, races, ethnicities, and genders; older patients are welcome in many studies. Learn more about older patients and clinical studies.