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Suggested Citation:"Appendix B: Workshop One Agenda." National Academies of Sciences, Engineering, and Medicine. 2019. Examining the Impact of Real-World Evidence on Medical Product Development: Proceedings of a Workshop Series. Washington, DC: The National Academies Press. doi: 10.17226/25352.
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Page 147
Suggested Citation:"Appendix B: Workshop One Agenda." National Academies of Sciences, Engineering, and Medicine. 2019. Examining the Impact of Real-World Evidence on Medical Product Development: Proceedings of a Workshop Series. Washington, DC: The National Academies Press. doi: 10.17226/25352.
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Page 148
Suggested Citation:"Appendix B: Workshop One Agenda." National Academies of Sciences, Engineering, and Medicine. 2019. Examining the Impact of Real-World Evidence on Medical Product Development: Proceedings of a Workshop Series. Washington, DC: The National Academies Press. doi: 10.17226/25352.
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Page 149
Suggested Citation:"Appendix B: Workshop One Agenda." National Academies of Sciences, Engineering, and Medicine. 2019. Examining the Impact of Real-World Evidence on Medical Product Development: Proceedings of a Workshop Series. Washington, DC: The National Academies Press. doi: 10.17226/25352.
×
Page 150
Suggested Citation:"Appendix B: Workshop One Agenda." National Academies of Sciences, Engineering, and Medicine. 2019. Examining the Impact of Real-World Evidence on Medical Product Development: Proceedings of a Workshop Series. Washington, DC: The National Academies Press. doi: 10.17226/25352.
×
Page 151
Suggested Citation:"Appendix B: Workshop One Agenda." National Academies of Sciences, Engineering, and Medicine. 2019. Examining the Impact of Real-World Evidence on Medical Product Development: Proceedings of a Workshop Series. Washington, DC: The National Academies Press. doi: 10.17226/25352.
×
Page 152
Suggested Citation:"Appendix B: Workshop One Agenda." National Academies of Sciences, Engineering, and Medicine. 2019. Examining the Impact of Real-World Evidence on Medical Product Development: Proceedings of a Workshop Series. Washington, DC: The National Academies Press. doi: 10.17226/25352.
×
Page 153
Suggested Citation:"Appendix B: Workshop One Agenda." National Academies of Sciences, Engineering, and Medicine. 2019. Examining the Impact of Real-World Evidence on Medical Product Development: Proceedings of a Workshop Series. Washington, DC: The National Academies Press. doi: 10.17226/25352.
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Page 154

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B Workshop One Agenda Workshop One: Incentives September 19–20, 2017 National Academy of Sciences Building, Lecture Room 2101 Constitution Ave. NW, Washington, DC 20418 The National Academies of Sciences, Engineering, and Medicine is convening a three-part workshop series examining how real-world evidence development and uptake can enhance medical product development and evaluation. The workshops will advance discussions and common knowledge about complex issues relating to the generation and usage of real- world evidence, including fostering development and implementation of the science and technology of real-world evidence generation and usage. This first workshop will include discussions, and background materials, that address: Aligning incentives and addressing barriers to support collection and use of real-world evidence in health product review, payment, and delivery. Workshops two and three will foster discussions that will: Illuminate what types of data are appropriate for what specific purposes and suggest approaches for data collection that match the right data to the right questions. (Q1 2018) Examine and suggest approaches for operationalizing the collection and use of real- world evidence. (Q3 2018) DAY 1: SEPTEMBER 19, 2017 8:00 a.m. Breakfast Available Outside the Lecture Room 8:20 a.m. Welcome and Opening Remarks P REP UBLI CATI ON COP Y: UNCORR ECTED P ROOFS 147

148 EXAMINING THE IMPACT OF RWE ON MEDICAL PRODUCT DEVELOPMENT GREG SIMON, Workshop Series Co-Chair Investigator Kaiser Permanente Washington Health Research Institute KEYNOTE ADDRESS 8:30 a.m. Vision and Goals of a Collaborative, Practical, and Sustainable Real-World Evidence Program SCOTT GOTTLIEB Commissioner U.S. Food and Drug Administration 8:50 a.m. Discussion with Audience Moderator: Mark McClellan, Duke-Margolis Center for Health Policy SESSION I SEEING OUR DESTINATION Session Objectives: Explore what relevant facts the ultimate end users of evidence need to know in order to make informed decisions about using medical products. Discuss possible approaches to generating such fit-for-purpose evidence. Moderator: Andy Bindman, University of California, San Francisco 9:00 a.m. A Payer Perspective MICHAEL SHERMAN Senior Vice President and Chief Medical Officer Harvard Pilgrim Health Care 9:20 a.m. Delivery System Perspective: Integrated Care Model at Kaiser Permanente MICHAEL HORBERG Executive Director, Research, Community Benefit, and Medicaid Strategy Executive Director, Mid-Atlantic Permanente Research Institute Kaiser Permanente Mid-Atlantic Permanente Medical Group 9:40 a.m. Delivery System Perspective: Academic Health System DANIEL FORD Director, Institute for Clinical and Translational Research P REP UBLI CATI ON COP Y: UNCORR ECTED P ROOFS

APPENDIX B 149 Johns Hopkins University School of Medicine 10:00 a.m. A Patient-Focused Perspective SHARON TERRY President and Chief Executive Officer Genetic Alliance 10:20 a.m. Discussion with Audience Additional Invited Discussants: JOANNE WALDSTREICHER Chief Medical Officer Johnson & Johnson ELEANOR PERFETTO Senior Vice President, Strategic Initiatives National Health Council 11:10 a.m. BREAK 11:30 a.m. Key Messages and Themes from the September 13 FDA/Duke-Margolis Workshop: Generating Fit-for-Purpose Evidence MARK MCCLELLAN, Workshop Series Co-Chair Director Duke-Margolis Center for Health Policy 11:50 a.m. Discussion with Audience 12:00 p.m. BREAK (Lunch Available Outside the Lecture Room) SESSION II LEARNING FROM SUCCESS Session Objectives: Highlight successful completed and ongoing initiatives that could potentially be examined for real-world evidence collection and use. Explore the features that led to the success in the given examples and how they could apply to future applications: o Conditions likely to make innovation successful; and o Potential ways to recreate those conditions to make real-world evidence use more routine. Moderator: Greg Simon, Kaiser Permanente Washington Health Research Institute P REP UBLI CATI ON COP Y: UNCORR ECTED P ROOFS

150 EXAMINING THE IMPACT OF RWE ON MEDICAL PRODUCT DEVELOPMENT 1:00 p.m. Generalizing and Scaling the Salford Lung Studies MARTIN GIBSON Chief Executive Officer Northwest EHealth MARIE KANE Chief Operating Officer Northwest EHealth 1:30 p.m. Using Sentinel to Evaluate Effectiveness or Efficacy RICH PLATT Professor and Chair, Department of Population Medicine Harvard Medical School 1:50 p.m. Applying Lessons Learned from Device Registries to Other Treatment Types RACHAEL FLEURENCE Executive Director National Evaluation System for Health Technology (NEST) Coordinating Center 2:10 p.m. Discussion with Audience Additional Invited Discussants: JOHN GRAHAM Head, Value Evidence and Outcomes GlaxoSmithKline RACHEL SHERMAN Principal Deputy Commissioner U.S. Food and Drug Administration 3:00 p.m. BREAK SESSION III GETTING UNSTUCK: ALIGNING INCENTIVES Session Objectives: In a series of presentations, discuss with treatment developers and evidence generators: Incentives maintaining the current data generation process; and Disincentives and potential barriers to incorporation of real-world evidence. Moderator: Petra Kaufmann, National Center for Advancing Translational Sciences, National Institutes of Health 3:20 p.m. Contract Research Organization Perspective P REP UBLI CATI ON COP Y: UNCORR ECTED P ROOFS

APPENDIX B 151 JOHN DOYLE Senior Vice President and Managing Director QuintilesIMS 3:40 p.m. A Product Developer Perspective ELLIOTT LEVY Senior Vice President, Global Development Amgen BRIAN D. BRADBURY Executive Director, Center for Observational Research Amgen 4:00 p.m. An Academic Researcher Perspective DANIEL FORD Director, Institute for Clinical and Translational Research Johns Hopkins University School of Medicine 4:20 p.m. Data Stewards: Organizations with Large Data Sources MARCUS WILSON President HealthCore, Inc. 4:40 p.m. Discussion with Audience Additional Invited Discussants: MICHAEL HORBERG Executive Director, Research, Community Benefit, and Medicaid Strategy Executive Director, Mid-Atlantic Permanente Research Institute Kaiser Permanente Mid-Atlantic Permanente Medical Group ANNA MCCOLLISTER-SLIPP Chief Advocate for Participatory Research, Scripps Translational Science Institute Founder, VitalCrowd Co-Founder, Galileo Analytics 5:30 p.m. ADJOURN WORKSHOP DAY 1 DAY 2: SEPTEMBER 20, 2017 8:00 a.m. Breakfast Available Outside the Lecture Room P REP UBLI CATI ON COP Y: UNCORR ECTED P ROOFS

152 EXAMINING THE IMPACT OF RWE ON MEDICAL PRODUCT DEVELOPMENT 8:30 a.m. Recap Day 1 and Discussion with Workshop Participants GREG SIMON, Workshop Series Co-Chair Investigator Kaiser Permanente Washington Health Research Institute KEYNOTE ADDRESS 9:00 a.m. False Precision and Estimating the Reliability of Effects with the Traditional Evidence-Generating Process ROB CALIFF Vice Chancellor, Health Data Science, Duke University Verily Life Sciences SESSION IV GETTING UNSTUCK: MYTH-BUSTING Session Objective: Examine ideas—and misconceptions—about the necessity and acceptability of established evidence-generation practices. Moderator: Rob Califf, Duke University and Verily Life Sciences 9:30 a.m. Moving from “One Study at a Time” to “All by All” Analyses PATRICK RYAN Senior Director and Head, Epidemiology Analytics Janssen Research & Development 9:50 a.m. A Medical Product Developer Perspective JOHN GRAHAM Head, Value Evidence and Outcomes GlaxoSmithKline 10:10 a.m. BREAK 10:30 a.m. Evolve or Die: The Urgent Need to Streamline Randomized Trials RORY COLLINS Head of Nuffield Dept of Population Health University of Oxford 10:50 a.m. A Regulatory Perspective P REP UBLI CATI ON COP Y: UNCORR ECTED P ROOFS

APPENDIX B 153 JANET WOODCOCK Director Center for Drug Evaluation and Research U.S. Food and Drug Administration 11:10 a.m. Discussion with Audience Additional Invited Discussant: DEVEN MCGRAW Deputy Director, Health Information Privacy Office for Civil Rights U.S. Department of Health and Human Services 12:30 p.m. ADJOURN WORKSHOP DAY 2 P REP UBLI CATI ON COP Y: UNCORR ECTED P ROOFS

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Randomized controlled trials (RCTs) have traditionally served as the gold standard for generating evidence about medical interventions. However, RCTs have inherent limitations and may not reflect the use of medical products in the real world. Additionally, RCTs are expensive, time consuming, and cannot answer all questions about a product or intervention. Evidence generated from real-world use, such as real-world evidence (RWE) may provide valuable information, alongside RCTs, to inform medical product decision making.

To explore the potential for using RWE in medical product decision making, the National Academies of Sciences, Engineering, and Medicine planned a three-part workshop series. The series was designed to examine the current system of evidence generation and its limitations, to identify when and why RWE may be an appropriate type of evidence on which to base decisions, to learn from successful initiatives that have incorporated RWE, and to describe barriers that prevent RWE from being used to its full potential. This publication summarizes the discussions from the entire workshop series.

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