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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.


Mary Elmer, BSN, MSN, RN


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

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 is the director of CDER’s Patient-Focused Drug Development (PFDD) Program, an effort to systematically obtain patient input and facilitate the incorporation of meaningful patient input into drug development and regulatory decision making. Prior to joining FDA, Robyn was... 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, Global Product Development, Pfizer Inc, United States
David is responsible for a portfolio of innovative approaches to address vital patient engagement challenges across Global Product Development. These challenges span the entire patient journey from before an individual might consider a clinical trial, their experience during a trial... Read More →

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