The purpose of an informed consent form (ICF) is to outline the risks and benefits of an interventional clinical trial to a patient. However, according to data presented on the final day of WCLC, most ICFs use scientific jargon and include extraneous information not pertinent to the patient.
The research (abstract 240) was presented by Bellinda King-Kallimanis, PhD, director of patient-focused research at LUNGevity Foundation, Bethesda, MD.
Dr. King-Kallimanis and her colleagues conducted a multi-step project involving patients and caregivers, trialists, regulators, and clinical trial sponsors to streamline the informed consent process. The first step included an audit of 20 ICFs guided by US Department of Health and Human Services regulations for the protection of human subjects in research. The second step involved focus groups and in-depth interviews with nine patients living with lung cancer to learn what information was critical when considering participation in a clinical trial using a hypothetical ICF to guide the conversation.
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The 20 ICFs reviewed in the group’s analysis were from phase 1, 2, and 3 clinical trials predominantly studying non-small cell lung cancer (NSCLC). Most of the Code of Federal Regulations topics legally required by the US Food and Drug Administration were covered in the 20 ICFs. However, the forms were long, ranging between 15 to 34 pages, with an average length of 21 pages. Readability varied by section, but the average reading level across all sections was 10th grade, whereas the average reading level in the US is 8th grade.
The second step of the study was the qualitative research component, in which participants were presented with a hypothetical ICF. Participants generally noted feeling “overwhelmed” by the hypothetical ICF. It was noted that “a lot of information was good,” but important information for deciding whether to participate was often too hard to find. When asked to explain the intent of ICFs, one study participant responded, “to cover their butts.”
The idea of an addendum that provides a summary referencing page numbers in the ICF for more details was well received by patients in the study. The next phase of this work is to develop a trifold addendum and test it with patients and caregivers, Dr. King-Kallimanis said.
“While ICFs place greatest emphasis on trial procedures and risks, variations in ICF architecture and readability make it difficult for patients to make an informed decision to participate in a clinical trial,” she said. “Our study implications extend beyond lung cancer, highlighting key areas for improvements to the ICFs and providing a clear roadmap for developing a patient-centric addendum for ICFs in all cancer clinical trials.”
