Back to Agendas
Returning Results to Study Participants: Health Literacy and Effective Language
Session Chair(s)
Barbara Godlew, RN
Associate Consultant, Scientific Communications, GSC-Bio-Medicines
Eli Lilly and Company, United States
Beginning in 2016, the European Clinical Trial (ECT) regulation will require clinical trial sponsors to provide trial results to the participants in a format and language appropriate and understandable to the participant. This session will focus on the history and principles of return of results to participants, including the history and generation of guidance for this effort, key principles of health literacy and numeracy that can guide the effective communication of study results, including language, formatting, and the presentation of data and discuss the integration and dissemination of health literacy principles driven by the need for clear communication for all audiences and not just those with limited literacy.
Learning Objective : Discuss the mandate for return of results to participants; Identify principles of the Multiregional Clinical Trials (MRCT) Return of Results guidelines for participant summaries; Identify principles of health literacy and numeracy in returning trial results to participants; Describe application and integration of these principles.
Speaker(s)
MRCT Principles and the Mandate for Transparency
Barbara E Bierer, MD
Harvard Medical School, United States
Faculty Director, MRCT Center; Professor of Medicine
Incorporation of Health Literacy Into the Corporate Structure
Laurie M. Myers, MBA
Merck & Co., Inc. , United States
Global Health Literacy Director
Regulatory Considerations in Implementing Clinical Trial Summaries for Study Participants
Nancy Ostrove, PhD
EXPRE , United States
Principal
Have an account?