Initial Steps in Creating a Patient-Centric Addendum to Clinical Trial Informed Consent Forms

Initial Steps in Creating a Patient-Centric Addendum to Clinical Trial Informed Consent Forms
King-Kallimanis, A. Ferris, L. Dropkin, M. Molina, L. Redway, U. Basu Roy
Journal of Thoracic Oncology, September 2022; 17(9) pp S71-S72
The purpose of the informed consent form (ICF) is to outline risks and benefits of an interventional clinical trial to a patient. In reality, most ICFs are written using scientific jargon, are long, and include extraneous information not pertinent to the patient (e.g., legalities of trial participation). Using lung cancer as a case study, we are conducting a multi-step project involving patients and caregivers, trialists, regulators, and clinical trial sponsors to streamline the informed consent process by creating a 1-2 page template addendum to the ICF summarizing key points relevant to patients.
Step 1 included an audit of 20 ICFs guided by 45 CFR 46, HHS regulations for the protection of human subjects in research, which requires the ICF to explain elements like which procedures are experimental. Step 2 included focus groups and in-depth interviews with patients with lung cancer (n=9) to learn what information was critical when considering a hypothetical ICF. In this abstract key, findings from steps 1/2 are summarized. Additional steps are planned to reach our final outcome.
The 20 ICFs reviewed were from phases 1, 2, and 3, expanded access and single patient trials covering predominantly non-small cell lung cancer and 60% were global trials. Average length of the ICFs was 21 (range 15-34) pages and most required CFR topics were covered. “What would happen if the trial failed” was least often covered (14 of 20). Average reading level was 10th grade, whereas average US reading level is 8th grade. Readability varied by section, “the purpose of the study” section had the highest reading level (11.5). In the qualitative research component (step 2), all participants were “overwhelmed” by the hypothetical ICF. When asked the intent of the forms, one participant noted “to cover their butts”. The idea of an addendum that provides a summary with reference to page numbers in the ICF for more details was well received. Participants were asked to list information they wanted included in the addendum (table). Suggestions broadly map to HHS regulations.
While ICFs place greatest emphasis on trial procedures and risks, variations in ICF architecture and readability mean it is difficult for patients to make an informed decision to participate in a clinical trial. 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.

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