Patient fears about experimental treatments, placebos, unnecessary testing, insurance coverage, and access are among the biggest barriers to enrollment in cancer clinical trials. Many of these fears are unfounded and are strong enough in the general population to slow down the pace of cancer research. Following are some of the myths that surround cancer clinical trials. Please read our Disclaimer.
Myth: Patients in cancer clinical trials are treated like guinea pigs.
Fact: Every effort is made to protect and promote the welfare of patients and to provide the best medical and nursing care possible. The medical teams that coordinate the care of patients in clinical trials have an obligation to let patients know what is happening during the trials and to answer any questions patients may have.
Myth: Cancer clinical trial patients have a chance of not being treated at all.
Fact: Patients who join cancer treatment trials are given the best cancer treatment options available. They may also have the chance to receive a new treatment or new ways of using existing treatments. Placebos, an inactive medicine designed to look like the medicine being tested, are rarely used in cancer clinical trials and never in place of standard treatment. For example, they may be used in a clinical trial that compares standard therapy plus a new treatment, with standard therapy plus a placebo. Using a placebo in this way can help prevent patients and their doctors from figuring out to which treatment group they were assigned and help prevent bias in research. The patient will always be told if the study uses a placebo.
Myth: Cancer clinical trial patients may not leave the trial even if their cancer grows worse and their health deteriorates.
Fact: The study doctor closely monitors each patient in the trial and may take a patient out of the study if the patient’s health changes and the study is no longer in their best interest. Also, the study doctor will tell the patient about new information or changes in the study that may affect their health or their willingness to continue in the study.
Myth: Patients cannot expect medical personnel to listen to their questions or keep them informed.
Fact: An important benefit of participating in a clinical trial is the high level of patient care. Patients in cancer clinical trials are usually followed more closely by their doctors and nurses. The research team has a duty to keep patients informed, make sure they understand the information, and answer any questions. Every patient will be given the name of a key contact person to stay in touch with throughout the trial.
Myth: Health insurance will not cover the costs of a cancer clinical trial.
Fact: Federal law requires most health insurance plans to cover routine patient care costs in clinical trials under certain conditions:
- the patient must be eligible for the trial
- the trial must be approved by the federal government
- the trial does not involve out-of-network doctors or hospitals, if out-of-network is not part of the patient’s plan
If a patient does join an approved clinical trial, most health plans cannot refuse to let them take part or limit their benefits. For more detailed information, please go to National Cancer Institute.
Myth: Medicare does not cover the costs of cancer clinical trials.
Fact: If patients have Medicare, they may be reimbursed for some of the costs related to taking part in trials of new ways to diagnose or treat cancer. For more detailed information: see the Centers for Medicare and Medicaid Services publication, Medicare and Clinical Research Studies and call Medicare at 1-800-MEDICARE (1-800-633-4227).
Myth: Patients need to be near a big hospital to take part in a cancer clinical trial.
Fact: Depending upon the type of cancer treatment, trials are conducted in doctors’ offices, cancer centers, other medical centers, community hospitals and clinics, and veterans’ and military hospitals in cities and towns across the United States and around the world.
Myth: Signing the informed consent document is the most important part of the process.
Fact: Putting a signature on an informed consent document is only part of the process for a person enrolled in a trial. The heart of informed consent is a participant’s ongoing interactions and discussions with the study doctor and other medical personnel, both during and after the cancer clinical study.
Myth: Once a patient signs the consent form, they have to enroll and stay enrolled in the study.
Fact: A patient can decide to stop at any time for any reason, but it is important to let the study doctor know as soon as possible to learn how to stop safely. Also, the study doctor may take a patient out of the study:
- if the patient’s health changes and the study is no longer in their best interest
- if new information becomes available
- if the patient does not follow study rules
- if the study is stopped by the sponsor or the federal agency that approved the trial
Myth: Informed consent is meant primarily to protect the legal interests of researchers.
Fact: The purpose of informed consent is to protect cancer clinical trial participants by giving information that can help people make informed choices about whether to take part in research. It also makes patients aware of their rights as a participant.