Clinical Trials: Myths and Misconceptions
When patients are given the option of enrolling in a clinical trial, they or their family members likely have many questions. The decision to participate in a clinical trial is a very personal one, and patients should always feel free to ask questions of their care team.
To better understand what a clinical trial is – and what it is not – UW Carbone Cancer Center clinical research manager Hilary Hernan, MPH, helps clear up some clinical trial myths and misconceptions.
Please note that the following information is for clinical trials in general; you should ask your care team to clarify any questions you have about your specific trial.
Myth: I’ll just be a “guinea pig” for testing new drugs
Although it is certainly understandable that patients have hesitation about receiving drugs that are not approved by the FDA, each clinical trial has gone through comprehensive reviews with a Scientific Review Board and a Human Subjects Protection Board (also referred to as the IRB) to ensure that subjects are treated safely and ethically. Preclinical testing of drugs is also required prior to giving the drugs to any human subjects. It is true that Phase I trials are designed to find a safe but effective dose. But again, the drugs and the clinical trial protocol are extensively reviewed prior to a Phase I trial. In a Phase II or III trial, decisions about safe doses of drugs are based off of the Phase I study information.
Myth: If I go on a study, I may be placed in the “placebo” group and not receive any treatment for my cancer at all
A placebo is a “drug” that is given that does not contain any active ingredients. So it may be something like a sugar pill or IV fluids. Many studies do include placebos. However, the placebo is used in studies where the standard of care treatment option may not work as well as we would like and researchers are trying to understand if an additional medication is better than what’s considered standard. It’s important to point out that everyone on these trials will still receive the standard of care; some patients will additionally receive the trial drug.
Myth: I will have to pay for the additional medical care I receive on a trial
Generally, research subjects do not have to pay anything additional for the costs associated with their care when they are part of a clinical trial. There are costs associated with a study that are considered “routine care”, which means patients would have those procedures done even if they weren’t in the study, and those costs are billed to the patient and/or insurance. We always encourage patients call their insurance company to confirm that they will cover these costs. The other type of cost associated with a study are considered “research costs” and will not be billed to insurance.
Myth: If I go on a study, all my medical costs will be covered
Like the statement above, if you are on a study, costs for procedures done only for the research study will be covered. However, any routine care procedures are still the responsibility of a patient and/or insurance.
Myth: If I am eligible for a study but say no, my care team will start treating me differently
The decision to participate in a study is entirely up to you. The care you receive at UW Health and the UW Carbone Cancer Center will not change if you choose not to participate in the study.
Myth: If I am offered a clinical trial, I have no other options for care
In some cases, a provider offers a clinical trial when there are no further standard-of-care options available to treat a patient. However, it is more likely that there are clinical trials available even when there are standard treatment options available as well. Studies often involve the standard treatment option plus an additional medication to see if that new medication helps. There are also several clinical trials available that help prevent or treat symptoms of cancer treatment, gather information about quality of life, or are meant to help prevent cancer. The decision to participate in a trial is a very personal one and we always want our patients to be well informed of their options. We encourage you to discuss your treatment options with your provider.
Myth: I will have to travel far, sometimes out of state, to participate in a study
Your provider will try to offer you a clinical trial that is available at UW Health so you would not have to travel further than Madison to participate. However, it is possible that UW Health does not have a trial available to you but another location does. In those situations, you may have to travel out of state to participate. As with all trials, the decision to participate is entirely up to you.
Myth: I can’t change my mind once I’m on the study no matter what
If you choose to participate in a study, you will always have the right to change your mind. This is true even if you’ve signed a consent form or have started treatment. The decision to participate in a trial or continue in a trial is always yours. We do recommend that you discuss your decision to go off study with your provider to ensure you stop your treatment in the safest way possible.