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Session 8 Track 2: Plain and Powerful: Mastering Clear Communication in Clinical Trials
Session Chair(s)
Sudipta Chakraborty, PhD
Clinical Trial Transparency Strategy Lead
Biogen, United States
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.
Learning Objective : - Describe key global regulations and guidances that require the use of plain language in clinical trial communications
- Identify key health literacy principles that aim to improve the understanding of clinical trial information in patients and the public
- Employ best practices that integrate patient perspectives and readability improvements into documents that empower patients and build trust in clinical research
Speaker(s)
Communicating with Patients: Are we Hitting the Mark?
Lisa Chamberlain-James, PhD
Trilogy Writing & Consulting, United Kingdom
Senior Partner
Revolutionizing Informed Consent: Empowering Medical Writers to Drive Patient-Centered Change
Marialena Davis, PhD, MS
Aroga Biosciences, United States
Regulatory Medical Writer