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Tuesday, June 26 • 8:00am - 9:30am
#217: Triple-A RWE: Adequate Data, Appropriate Study Designs, and Actionable Evidence

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Component Type: Forum
Level: Advanced
CE: ACPE 1.50 Knowledge UAN: 0286-0000-18-570-L04-P; CME 1.50; IACET 1.50; RN 1.50

The last several years have seen increasing effort to better understand when and how real-world data and evidence could better support a wide range of regulatory decisions. And while sponsors, researchers, policymakers, and regulatory agencies continue to develop real world evidence (RWE) frameworks to achieve that express aim, guiding principles are emerging related to the selection of adequate real-world data sources and appropriate study designs within specific regulatory contexts: How do specific characteristics related to disease area, data source, or analytical method affect questions around maintaining randomization? When can well-done observational studies suffice for generating actionable evidence? Are we nearing truly proof-of-concept pilot opportunities?

Speakers
avatar for Paul Bleicher

Paul Bleicher

Chief Executive Officer, OptumLabs
Paul Bleicher, MD, PhD, is CEO of OptumLabs, a collaborative research and innovation center. Previously, he was CMO for Humedica, a next-generation clinical informatics company. He founded Phase Forward, which helped bring clinical trials from paper to the web. Dr. Bleicher holds... Read More →
avatar for Jacqueline Corrigan-Curay

Jacqueline Corrigan-Curay

Director, Office of Medical Policy, CDER, FDA
Jacqueline Corrigan-Curay, J.D., M.D., serves as Director of the Office of Medical Policy (OMP) in the Center for Drug Evaluation and Research, FDA. OMP is comprised of the Office of Prescription Drug Promotion (OPDP) and the Office of Medical Policy Initiatives (OMPI). Dr. Corrigan-Curay... Read More →
avatar for Cathy Critchlow

Cathy Critchlow

Vice President, Center for Observational Research, Amgen Inc.
Dr. Critchlow leads Amgen’s Center for Observational Research, providing strategic leadership to the design & conduct of observational studies for multiple stakeholders. Their Real World Data Platform with data for 160M patients uses a common data model and visualization/analytic... Read More →
avatar for Gregory Daniel

Gregory Daniel

Deputy Director and Clinical Professor, Duke-Margolis Center For Health Policy
Gregory Daniel, PhD, MPH is the Deputy Director of the Duke-Robert J. Margolis, MD Center for Health Policy and a Clinical Professor in Duke's Fuqua School of Business. He directs the DC-based office of the Center leading its pharmaceutical and medical device policy portfolio, and... Read More →
avatar for Pall Jonsson

Pall Jonsson

Associate Director Research and Development, National Institute for Health and Care Excellence (NICE)
Dr Jonsson heads Research and Development UK's National Institute for Health and Care Excellence (NICE). He leads NICE's contribution to a portfolio of international research projects, in areas including big data and real-world evidence. Dr Jonsson has a PhD in biochemistry from University... Read More →


Tuesday June 26, 2018 8:00am - 9:30am
Room 210AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  • Level Advanced
  • format json
  • Credit Type ACPE, CME, IACET, RN
  • Tags Forum