Among those who recruit patients for lung cancer clinical trials, it is likely most feel the process is too difficult. Now, new research presented at the International Association for the Study of Lung Cancer (IASLC) World Conference on Lung Cancer in Vienna shows that one barrier to enrolling new patients in a clinical study are the informed consent forms (ICFs).
While ICFs are intended to provide vital information about the risks and benefits of a potential treatment, researchers at the LUNGevity Foundation found that they are often overwhelming to patients, written using jargon and containing information not pertinent to the clinical trial. As such, these ICFs may actually impede enrolling new patients, said Bellinda King-Kallimanis, PhD., LUNGevity’s director of patient-focused research.
For this study, a team of researchers led by King-Kallimanis engaged multiple stakeholders including patients and caregivers, trialists, regulators, and clinical trial sponsors to look for ways to improve the informed consent process. As a first step, the team audited 20 ICFs that were guided by U.S. Department of Health and Human Services regulations for the protection of human subjects in research. The ICFs reviewed were from Phase I, II, and III clinical trials and were predominantly for non-small cell lung cancer. Of the 20 ICFs, 12 were for global trials. While most of the legally required CFR topics were covered, the forms were long, ranging from 15 to 34 pages, and averaged 21 pages. Readability varied by section but the average reading level across the section was 10th grade, whereas average US reading level is 8th grade.
In the qualitative stage of the research, patients were provided with a hypothetical ICF and asked to provide their opinions. Study participants noted generally feeling overwhelmed by the hypothetical ICF, while the depth of information presented was considered good, the participants said that it was difficult to find the most important information about the trial that was needed to make the decision to participate.
An idea that emerged from the interviews to make the consent process easier—and to make the ICFs easier to understand—was to create an addendum for ICFs that provides a summary of the information provided, along with page references if the patient was interested in digging deeper. Based on how well this was received by the participants in the study, the team’s next step will be to create a tri-fold addendum to the hypothetical ICF to test how effective it is for caregivers and patients.
“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,” King-Kallimanis said in a press release. “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.”