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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?

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
Dr. Corrigan-Curay brings to the position a unique legal, scientific policy, and clinical background with expertise in risk and scientific assessment, and clinical trial design and oversight. Before joining FDA, she served as supervisory medical officer with the Immediate Office of... 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
Dr. Gregory Daniel is Deputy Director and Clinical Professor in the Duke-Robert J. Margolis Center for Health Policy. Dr. Daniel directs the DC-based office and leads its pharmaceutical and medical device policy portfolio aimed at developing strategies for improving development 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