Patient Review of Informed Consent Form as Best Practice in Clinical Trial Design

Background: The informed consent form (ICF) is one of the most important documents in a clinical trial, because it contains all essential and relevant information on both what will happen within a study and what is expected and provided to a study participant. However, rigorous reviews by members of the patient population being studied are not done consistently in the study design and development process. Our objective was to optimize readability and understandability of patient-facing clinical study materials for kidney transplant-related interventional clinical trial by facilitating asynchronous review of informed consent form (ICF) by global panel of kidney transplant patients and advocates. Methods: Three separate asynchronous 10-day reviews of draft ICF were provided to individual (3) global patient reviewers via a secure online platform in August, October, and December 2023. Results: Elevate Advocacy, in partnership with one of its sponsor clients, facilitated three separate reviews by three global patients and advocates who had experience with post-kidney transplant complications. Although the three reviewers were from different countries, racial and ethnic backgrounds, trial experience (e.g., naive vs experienced), sexes, and ages, 68% of their comments and suggestions were independently aligned. In total, 183 comments, questions and suggestions were provided on a 19-page draft ICF. An in-depth review of all comments was conducted to understand what feedback should be incorporated into the ICF (50%). Recommendations included: ● A schematic design of the study visits, dosing schedule, and timeline ● A pronunciation guide for the study drug ● Language that was universally understood by global audiences ● Formatting changes of dense text into sections and bulleted lists Conclusion: Patients and advocates can provide valuable insights and feedback on patient-facing study materials to make them more understandable for clinical trial participants. Patient-facing study materials review can be a safe, low-cost, and highly valuable exercise that benefits both the study and the study participants. To be most successful, reviews should be iterative and allow enough time for patient reviewers to provide feedback (7-10 days), internal program teams to analyze and discuss the incorporation of comments into the ICF, and internal review committees to determine if template changes should be made. Funding: Commercial Support - argenx