Creating patient-friendly informed consent form (ICF): Insights from global oncology patient insights panels (GOPIPs).

Abstract

e24199 Background: The informed consent form (ICF) provides patients with information to facilitate an informed decision about participation in a clinical trial. Legal and regulatory requirements, professional jargon and technical terms make ICFs long and complicated, creating barriers for patients to understand the participation requirements, which may lead to negative impact on recruitment and increased drop-out rates. Methods: Patient advocates with relevant knowledge of patient experiences in their respective disease areas were invited to review, edit, and provide recommendations for improving draft ICFs for company clinical trials to facilitate better understanding. These advocates are members of the Global Oncology Patient Insight Panels (GOPIPs), contracting with the company to provide the patient perspective along the clinical development continuum. The advocates received draft ICFs and completed a questionnaire regarding its readability, content, and formatting, or provided open-ended feedback. Researchers interviewed advocates to elicit in-depth responses and recommendations for improvement. A qualitative analysis was performed on all data collected to identify primary themes, which were incorporated into an internal guidance for clinical development teams, “Tips for Creating Patient-friendly ICFs: Insights from Global Oncology Patient Insights Panels (GOPIPs) 2018-2022.” Results: 36 draft ICFs for clinical trials were reviewed by 47 advocates in 13 hematology/oncology disease areas and 14 countries between 2018 and 2022. Qualitative analysis identified 5 primary themes: 1) Create easy-to-read documents through simplifying words and using visuals; 2) clearly communicate participation requirements in patient friendly terms, including an executive summary or table of logistical, financial, and patient reported outcomes requirements; 3) provide transparency: background on the treatment and personnel involved in study, explain the study’s privacy policies and what happens if the patient is no longer eligible for the trial; 4) provide supplemental information materials to aid understanding; 5) provide instructions for the investigator/trial team presenting the patient with the ICF. Conclusions: Feedback provided aligns with a recent proposal by the FDA to change existing regulations on informed consent to “facilitate a prospective [trial participant’s] decision about whether to participate in the research.” Findings from this analysis of patient advocate insights will be used to update the organization’s ICF template with improved comprehensibility of the form.