MA08.04 Initial Steps in Creating a Patient-Centric Addendum to Clinical Trial Informed Consent Forms

      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.
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