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Session 5: Clarity in Clinical Trials
Session Chair(s)
Francine Lane, MBA
Senior Director of Product Management, Citeline, United States
This comprehensive session explores the critical role of Plain Language Summaries (PLS) in clinical trial disclosure, addressing the EU CTR requirement and global best practices. Attendees will gain insights into developing effective summaries that adhere to health literacy principles, navigate regulatory requirements, and overcome common challenges in the field. The session will also delve into the value of plain language writing in clinical research operations and explore the patient perspective plain-language summaries.
Learning Objective : - Develop a toolkit of industry-proven strategies for crafting Plain Language Summaries (PLS)
- Explain key challenges in maintaining consistency and protecting participant privacy when reporting clinical trial endpoints and safety data in plain language formats
- Identify and evaluate the primary sources where patients find and access clinical trial information
Speaker(s)
Oladayo Oyelola, PHD
Trial and Disclosure Operations Consultant, Independent Consultant, United States
The Value of Plain Language Writing in Clinical Research Operations and Medical Communication
Maureen Kashuba, BSN
Director, Health Literacy Projects , Merck & Co., Inc., United States
Navigating EU CTR: Mastering Effective Lay Protocol Synopses (LPS) and Plain Language Summary (PLS) Development
Deborah Collyar
President, Patient Advocates In Research (PAIR), United States
PLS Strategies That Work for Patients, Sites, & Sponsors
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