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Global Clinical Trial Disclosure and Data Transparency Conference

Learn about the latest requirements in clinical trial disclosure and data transparency, share best practices, and engage in in-depth discussions on hot topics.


Session 7: Patient Focus in Disclosure: From Intent to Action

Session Chair(s)

Patrick  Fawcett

Patrick Fawcett

  • Information Disclosure Administrator, Office of Research Protections
  • University of Pittsburgh, United States
Deborah  Collyar

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)

Robyn  Bent, MS, RN

Speaker

Robyn Bent, MS, RN

  • Director, Patient Focused Drug Development Program, OCD, CDER
  • FDA, United States
Dyan  Bryson, MBA

Speaker

Dyan Bryson, MBA

  • Patient Engagement Strategist/Patient Advocate
  • Inspired Health Strategies, United States
Catina  O'Leary, PhD

Speaker

Catina O'Leary, PhD

  • President and Chief Executive Officer
  • Health Literacy Media (HLM), United States
Ting  Pun, PhD

Speaker

Ting Pun, PhD

  • Volunteer Stanford Healthcare Patient Partner
  • Iconquerms, United States