Medical Affairs and Scientific Communications Forum

With the implementation of recent regulations, the role of plain language in communicating clinical trial information to patients, the public, and regulators has risen to the forefront of transparency and disclosure commitments. From plain language summaries of results and of publications to the new kid on the block (plain language protocol synopses), medical writers must be equipped with the knowledge and skill set to translate technical information into plain language that serves a variety of audiences. In this session, we will explore the ways to effectively produce plain language documents that are fit-for-purpose. Attendees will learn key health literacy principles that highlight the difference between writing for patients and writing for regulators, including challenges in explaining complex ideas like benefit and risk to a lay audience. Then, we will dive into recent updates to regulatory guidances related to informed consent forms (ICFs). This will include tips and tricks to transform ICFs from a legal formality to a meaningful and understandable document that builds trust and empowers patients at the start of their clinical trial journey. Overall, this session aims to empower medical writers with the understanding and skill set required to produce clear, meaningful, and patient-centered clinical trial communications.