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Challenges and Best Practices for Writing Lay Summaries of Clinical Study Results
Session Chair(s)
Thomas Schindler, PHD
Director Global Regulatory Affairs - Regulatory Operations
BioNTech SE, Germany
The EU Regulation 536/2014 requires that sponsors provide summaries of study results that are understandable for lay people. While the regulation provides a framework in regard to the content, many questions remain. Which information is most important for lay readers? How much numerical information should be provided? This session will address the key challenges in the writing of lay summaries and will demonstrate potential solutions.
Speaker(s)
Returning Overall Trial Results in “Lay Language” – Successes and Challenges in Global Implementation
Behtash Bahador, MS
Center for Information and Study on Clinical Research Participation (CISCRP), United States
Senior Director, Community Engagement & Partnerships
Feedback from Lay Summary Testing and General Principles in Writing Summaries for Lay Audiences
D.K.Theo Raynor, PHD, MPHARM
University of Leeds, United Kingdom
Professor of Pharmacy Practice
The WHO Registry Perspective: 10 Years of Experience with Information on Clinical Trials in Lay Language
Gabriele Dreier, DrMed
Medical Center - University Freiburg, Germany
Head of Cooperations and Networks