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Thursday, June 18 • 5:00pm - 6:00pm
#529 OD: ON DEMAND - Impact Patient Centered Initiatives in Clinical Trial Design and Execution

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Component Type: Session
Level: Intermediate

The Patient Experience Initiative developed tools to provide more effective ways to engage with patients in design and execution of clinical studies. These tools will be presented and their impact will be discussed.

Learning Objectives

Discuss patient perspectives on clinical trial access, design, conduct and post-trial follow-up, based on recent forums and collaborations; Describe publicly available tools for engaging patients in study design and measuring experiences during clinical trials; Describe how gathering patient feedback during protocol development and from clinical study patients during the study may help improve patient experience and reduce patient burden.

Chair

Mary Elmer, BSN, MSN, RN

Speaker

A Stage IV Cancer Patient's Perspective on Clinical Trials
Laura Holmes Haddad

Putting Patients at the Heart of Clinical Research: New Learnings, Solutions, and Best Practices
Pamela Tenaerts, MD, MBA

Multi-Stakeholder Approach to Incorporating the Patient Voice into Medicines Development
David Leventhal, MBA

Patient Focused Drug Development: Considerations for Clinical Trial Design and Execution
Robyn Bent, MS, RN



Speakers
avatar for Pamela Tenaerts

Pamela Tenaerts

Executive Director, Clinical Trials Transformation Initiative (CTTI), United States
Pamela Tenaerts is the Executive Director at the Clinical Trials Transformation Initiative (CTTI) where she works closely with the Executive Committee to develop and implement strategies to accomplish CTTI’s mission. She provides senior level oversight of the day-to-day operations... Read More →
avatar for Mary Elmer

Mary Elmer

Executive Director, Patient Innovation Organization, Merck & Co., Inc.
Mary Elmer is the Executive Director of Patient Insights for Oncology at Merck. This group seeks to obtain patient insights and engages patients in optimizing their health, wellbeing, and healthcare outcomes. In her prior role, she led a patient engagement team that brings the voice... Read More →
avatar for Robyn Bent

Robyn Bent

Director, Patient Focused Drug Development Program, OCD, CDER, FDA, United States
Robyn Bent joined the US FDA in 2019 as the director of CDER’s Patient-Focused Drug Development (PFDD) Initiative, an effort to systematically obtain patient input and facilitate the incorporation of meaningful patient input into drug development and regulatory decision making... Read More →
avatar for Laura Holmes Haddad

Laura Holmes Haddad

Writer & Speaker, Patient Advocate, Independent Consultant
avatar for David Leventhal

David Leventhal

Senior Director, Clinical Trial Experience, Pfizer Inc
David is Senior Director, Clinical Trial Experience, Pfizer, Inc., He is responsible for External Engagement and Clinical Trial Participant Experience activities within the Global Product Development (GPD) Division. In this role, he is responsible for developing innovative approaches... Read More →


Thursday June 18, 2020 5:00pm - 6:00pm EDT
TBD Virtual Event Horsham, PA 19044