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Sunday, June 23 • 9:00am - 12:30pm
SC20: #20: Real World Evidence Studies to Evaluate the Safety and Effectiveness of Therapeutic Interventions – Is the Data Fit for Purpose and How Will You Know?

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Component Type: Tutorial
CE: ACPE 3.25 Knowledge UAN: 0286-0000-19-500-L04-P; CME 3.25; IACET 3.25; RN 3.25

This course will provide an overview of how real-world evidence is being used today for evidence generation in major markets. The primary focus is evidence generation for regulatory use, with a particular focus on comparative effectiveness, but the approaches described here are useful for health technology assessments for payers. Following the major points identified by the FDA in the Frameworks document released in December, 2019, we will explain how the fitness of evidence from real-world data are assessed for any use case, key elements of design and analysis, and the current status of FDA guidance on when real-world studies will be sufficient to meet regulatory evidence requirements. Although much of the focus will be on the FDA, the course will also include an update of recent activities by the EMA regarding use of real-world (big) data. An additional registration fee is required for all preconference short courses. Back to DIA 2019 Short Courses

Who should attend?

This short course is designed for members of the Clinical Research and Regulatory audiences.

Learning Objectives

At the conclusion of this course, participants should be able to:
  • Describe key epidemiological design principles central to interpreting the quality and validity of RWE studies;
  • Apply these learnings by evaluating and discussing case presentations focused on CV safety assessments;
  • Recognize when RWE based approaches are of sufficient quality to enable decision making.

avatar for Brian Bradbury

Brian Bradbury

Executive Director, Head, Data and Analytics, Center for Observational Research, Amgen, Inc.
Brian D. Bradbury is Executive Director in the Center for Observational Research (CfOR) at Amgen, Inc, and an Adjunct Assistant Professor of Epidemiology at UCLA. He leads a team of epidemiologists, biostatisticians, data scientists and programmers who use real-world data (RWD) to... Read More →
avatar for Nancy Dreyer

Nancy Dreyer

Chief Scientific Officer and Senior Vice President, IQVIA
Nancy Dreyer is Chief Scientific Officer and SVP at IQVIA. She crafts real-world evidence for regulators, clinicians, patients and payers through pragmatic trials and non-interventional studies. An Adjunct Professor of Epidemiology at the U. of N Carolina School of Global Public Health... Read More →
avatar for Jessica Franklin

Jessica Franklin

Assistant Professor of Medicine, Div of Pharmacoepidemiology and Pharmacoeconomi, Brigham and Women's Hospital and Harvard Medical School
Jessica Franklin, PhD, is an Assistant Professor of Medicine at Harvard Medical School and biostatistician in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital. Her research focuses on developing and applying statistical methods for the study... Read More →
avatar for Paul Muntner

Paul Muntner

Professor of Epidemiology and Associate Dean for Research, University of Alabama at Birmingham
Paul Muntner is Associate Dean for Research and Professor of Epidemiology at the University of Alabama at Birmingham. He earned a Master’s degree in biostatistics and a doctorate degree in epidemiology from the Johns Hopkins University. Since 2014, he has served as Co-Director of... Read More →

Sunday June 23, 2019 9:00am - 12:30pm PDT
Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  Short Course, Tutorial |   01: ClinSafety-PV, Tutorial
  • Level Intermediate
  • Featured Topics Real World Evidence
  • Credit Type ACPE, CME, IACET, RN
  • Tags Tutorial