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Session 7: Patient Focus in Disclosure: From Intent to Action
Session Chair(s)
Patrick Fawcett
Information Disclosure Administrator, Office of Research Protections
University of Pittsburgh, United States
Deborah Collyar
President
Patient Advocates In Research (PAIR), United States
This session will help attendees turn intent into action concerning patient focused clinical trial disclosure practices. The US FDA’s Patient-Focused Drug Development (PFDD) Program will be highlighted as a systematic approach to help ensure that patients’ experiences, perspectives, needs, and priorities are captured and meaningfully incorporated into drug development and evaluation. Implications for clinical trial disclosure will be introduced, followed by a panel discussion covering the sponsor, regulator, and patient perspectives.
Learning Objective : At the conclusion of this session, participants should be able to:
- Apply the principles of PFDD to clinical trial disclosure practices
- Use disclosure as a tool for achieving the global aims of PFDD
- Adapt disclosure practices to achieve greater diversity of clinical trial participant populations
Speaker(s)
Speaker
Robyn Bent, MS, RN
FDA, United States
Director, Patient Focused Drug Development, OCD, CDER
Speaker
Dyan Bryson
Inspired Health Strategies, United States
Global Strategic Solutions, Clinical Operations Lead, DEICT
Speaker
Catina O'Leary, PhD
Health Literacy Media, United States
President and Chief Executive Officer
Speaker
Ting Pun, PhD
Stanford Health Care, United States
Patient Partner
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