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Tuesday, June 20 • 2:00pm - 3:00pm
#260: Comparative Effectiveness: State of the Art and Stakeholder Perspectives

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-17-510-L04-P; CME 1.00; IACET 1.00; RN 1.00

In this session, we will think through the designs and endpoints for comparative effectiveness and safety. This work is typically performed by NIH and PCORI in the US but has been proposed to CDER and CBER.

Learning Objectives

Review key areas where multiple stakeholders are converging around real world evidence for effectiveness, safety and value; Discuss the importance of patient-relevant endpoints in effectiveness and safety from PCORI's perspective; Describe how changing regulations may impact health technology assessment.


Robert W DuBois, MD, PhD


Mind the ‘Efficacy-Effectiveness’ Gap: Will Changes in Regulations on Real-World Research Revolutionize Health Technology Assessment?
David Thompson, PhD

Update From PCORI
Jean Slutsky, MPH

avatar for Robert DuBois

Robert DuBois

Executive Vice President and Chief Science Officer, National Pharmaceutical Council
Robert W. Dubois, MD, PhD, is the chief science officer and executive vice president of the National Pharmaceutical Council (NPC). Dr. Dubois, who is board certified in internal medicine, brings more than 25 years of experience in health care research. Dr. Dubois received his AB from... Read More →

avatar for Jean Slutsky

Jean Slutsky

Chief Engagement and Dissemination Officer, Patient-Centered Outcomes Research Institute (PCORI)
Jean Slutsky is PCORI’s Chief Engagement and Dissemination Officer leading engagement activities and dissemination and implementation efforts. Before joining PCORI, Slutsky directed the Center for Outcomes and Evidence at the Agency for Healthcare Research and Quality, where she... Read More →
avatar for David Thompson

David Thompson

Senior Vice President, Real World Evidence Consulting, Inventiv Health
David Thompson, PhD is Senior Vice President, Real World Evidence & Insights, for InVentiv Health. Dr. Thompson is a health economist with 25+ years of experience in the real-world research arena. Prior to joining inVentiv Health, he held leadership positions at Quintiles (2012-2016... Read More →

Tuesday June 20, 2017 2:00pm - 3:00pm CDT
S405b McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
  10: Value-Access, Session