CLINICAL TRIALS ARE THE GOLD STANDARD for advancing the practice of evidence-based medicine and potentially improving patient outcomes. They’re necessary for determining if a new drug, medical device, product or approach is safe and effective. Yet, the American Society of Clinical Oncology estimates that less than 5% of adults with cancer choose to participate in clinical trials.
One likely barrier is the informed consent form itself. Voluntary consent is legally required for patients to enroll in a study, but what are you signing up for, exactly? It’s not always easy to tell. “Informed consent forms, which outline the risks and benefits of an interventional clinical trial to a patient, are overwhelming and complicated,” says Bellinda King-Kallimanis, director of patient-focused research at LUNGevity Foundation in Bethesda, Maryland.
King-Kallimanis and her colleagues reviewed 20 informed consent forms from clinical trials covering predominantly non-small cell lung cancer. They also hosted focus groups of people given typical informed consent forms to read and asked them how patient-friendly the process was. King-Kallimanis presented the preliminary results of the project in August at the International Association for the Study of Lung Cancer’s World Conference on Lung Cancer in Vienna.
“We generally found that informed consent forms are long, an average of 21 pages, and that information for deciding whether to participate in the trial, such as potential side effects, was hard to find. And informed consent forms are generally written at a 10th grade reading level, which may be too high for many people,” King-Kallimanis says. The average U.S. reading level is seventh to eighth grade, according to the Center for Plain Language.
Informed consent forms must meet certain content criteria, established by the U.S. Department of Health and Human Services, to provide enough information to allow potential study participants to make an informed decision about joining the trial. Yet, these forms aren’t standardized. Trial organizations have leeway in terms of reading level or how the information is presented.
According to King-Kallimanis’ research, adding a short, patient-friendly addendum that summarizes key points about the trial that are most relevant to patients is a step toward making informed consent forms less intimidating. The addendum should include pertinent information—such as the criteria for being included in the study, a description of the treatments in the trial and control arms of the study, the most important side effects to be aware of, how the drug will be administered, and information on privacy—in a bulleted format with handy page number references patients can turn to for more information.
Understanding the Informed Consent Process
Follow these steps to help make enrolling in a clinical trial easier.
There’s more work to be done to making the informed consent process more patient-friendly. Meanwhile, Bellinda King-Kallimanis, director of patient-focused research at LUNGevity Foundation, recommends taking these steps to help make enrolling in a clinical trial easier, especially if you’re also experiencing the anxiety of a cancer diagnosis.
- Check with your doctor or nurse navigator. If you don’t understand something about the clinical trial on the informed consent form, ask your doctor or nurse to explain. “They want to help you understand it,” King-Kallimanis says.
- Phone a friend. If you’re alone at your medical appointment and unsure about signing an informed consent form, take a minute to call a trusted friend or family member for their opinion.
- Don’t feel pressured to sign on the spot. “It’s your health care decision. If you need extra time to read through the consent form and decide on whether to participate in a clinical trial, you should take it,” King-Kallimanis says.
Wenora Johnson, a patient advocate in the Chicago area and herself a three-time cancer survivor, is in favor of simplifying the informed consent form as a way of recruiting more participants, particularly patients of color, who are generally underrepresented in clinical trials. “We want more people of color to participate in clinical trials because a treatment that works for one group of individuals may not have the same impact for us,” says Johnson, who is Black. She contends that informed consent forms should be written in layman’s terms, without legalese or medical jargon. “Language that’s easy to understand can help patients decide whether they want to participate or not,” Johnson says. “But sometimes it’s a matter of just being asked to participate in a clinical trial, then breaking down what the ask is. If the informed consent form is too confusing, speak up and ask questions.”
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