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Session 6 Track 2: Plain Language and Patient Engagement
Session Chair(s)
Sudipta Chakraborty, PhD
Plain Language Summaries / Clinical Trial Transparency Manager
PRA Health Sciences, United States
Current regulatory requirements showcase the global interest in improving clinical trial transparency, including the upcoming implementation of plain language summaries. However, the role of the patient voice should be considered throughout the drug development process. Sponsors may not currently be situated to plan for transparency requirements at earlier stages, including protocol design. In this panel discussion, the audience will hear varying perspectives related to these issues. This will include a scientist who doubles as a patient advocate for her son’s rare disease, as well as a non-profit organization geared towards educating the public and patients about the clinical trial process. The panel will also include speakers from 2 major pharmaceutical companies who have set up their organization for success in putting the patient first.
Learning Objective : At the conclusion of this session, participants should be able to:
- Recognize the importance of patient input earlier and throughout the drug development process
- Identify ways to integrate health literacy and the patient voice into regulatory writing
- Assess how current pharmaceutical companies are already employing patient-forward initiatives
Speaker(s)
Speaker
Terry Jo Bichell, PhD, MPH
COMBINEDBrain, United States
Founder and Director
Speaker
Laurie M. Myers, MBA
Merck & Co., Inc. , United States
Global Health Literacy Director
Speaker
Behtash Bahador, MS
Center for Information and Study on Clinical Research Participation (CISCRP), United States
Director, Health Literacy
Speaker
Vivian Larsen, MBA
Legacy Health Strategies, United States
Chief Operating Officer
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