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Wednesday, June 21 • 10:30am - 11:45am
#328: Real-World Data to Real World Evidence for Assessing Efficacy and Effectiveness

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-17-560-L04-P; CME 1.25; IACET 1.25; RN 1.25

In the US and EU, there are opportunities and challenges for new medicines development, regulatory review, and health technology. The efficacy and effectiveness gap is challenging the value in decision making and the generalizability of findings from the traditional gold standard randomized controlled trials (RCT) to use of medicines outside of the studied population. Many decisions that need to be made by HTA agencies must rely on the RCT-generated evidence in their analysis and deliberations with respect to the expected effectiveness of new medicines.

Join Patient Engagement Community for a follow up Round Table discussion at 12:00pm in the Community Corner.

Learning Objectives

Evaluate whether RWD can enable decision making by complementing evidence from RCTs using data from other sources, including observational studies, EHRs, claims databases, or other nonstandard information sources.


Lawrence Eugene Liberti, MS, RPh, RAC


Using Real World Evidence and Real-World Data to Build Confidence in Regulatory Decision-Making
Jonathan P. Jarow, MD, PhD

Using Real World Evidence and Real-World Data to Inform New Indications and Build Confidence in a Development Plan
James Harnett, PharmD, MS

How Various Stakeholders are Using or Thinking of Using Real World Evidence and Real-World Data to Inform Their Decisions
Jean Slutsky, MPH

avatar for Lawrence Liberti

Lawrence Liberti

Head, Regulatory Collaborations, Centre for Innovation in Regulatory Science (CIRS)
Dr Liberti has worked in pharmaceutical regulatory affairs, communications and clinical R&D for the past four decades. Since 2009 he has served as the Executive Director of CIRS (the Centre for Innovation in Regulatory Science, Ltd, forming part of Clarivate Analytics). He has been... Read More →


James Harnett

Senior Director, Lead, Real World Data and Analytics, Patient & Health Impact, Pfizer Inc.
Dr. James Harnett is a Senior Director in Real World Data and Analytics (RWDnA) for Pfizer’s Patient Health & Impact organization. Dr. Harnett has worked at Pfizer for over 15 years and supported establishing the RWDnA function. He has conducted research across numerous therapeutic... Read More →
avatar for Jonathan Jarow

Jonathan Jarow

Senior Medical Advisor, FDA
Dr. Jonathan P. Jarow is currently the senior medical advisor to the Center Director and chair of the medical policy council in CDER at FDA. Jonathan previously served as the director of CDER’s Office of Medical Policy and as deputy director of the Office of Hematology and Oncology... 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 →

Wednesday June 21, 2017 10:30am - 11:45am CDT
N230b McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
  10: Value-Access, Session