building the national evaluation system for medical ......us dollars (inflation-adjusted) spent on...
TRANSCRIPT
![Page 1: Building the National Evaluation System for Medical ......US dollars (inflation-adjusted) spent on research and development (R&D) has halved roughly every 9 years since 1950. Scannell](https://reader033.vdocument.in/reader033/viewer/2022042413/5f2d242ee7da4301390784d4/html5/thumbnails/1.jpg)
Building the National Evaluation
System for Medical Devices
The Role of MDEpiNet PPP
J. Matthew Brennan, MD, MPH Interventional Cardiology
Duke Triangle Heart Associates
Assistant Professor of Medicine
Duke University School of Medicine
![Page 2: Building the National Evaluation System for Medical ......US dollars (inflation-adjusted) spent on research and development (R&D) has halved roughly every 9 years since 1950. Scannell](https://reader033.vdocument.in/reader033/viewer/2022042413/5f2d242ee7da4301390784d4/html5/thumbnails/2.jpg)
All Rights Reserved, Duke Medicine 2007
Overview
![Page 3: Building the National Evaluation System for Medical ......US dollars (inflation-adjusted) spent on research and development (R&D) has halved roughly every 9 years since 1950. Scannell](https://reader033.vdocument.in/reader033/viewer/2022042413/5f2d242ee7da4301390784d4/html5/thumbnails/3.jpg)
All Rights Reserved, Duke Medicine 2007
Eroom’s Law. The number of new drugs approved by the FDA per billion US dollars (inflation-adjusted) spent on research and development
(R&D) has halved roughly every 9 years since 1950.
Scannell et al., Nature Reviews Drug Discovery 11:191, 2012
Product Development in the U.S. Increasingly Slow & Expensive
![Page 4: Building the National Evaluation System for Medical ......US dollars (inflation-adjusted) spent on research and development (R&D) has halved roughly every 9 years since 1950. Scannell](https://reader033.vdocument.in/reader033/viewer/2022042413/5f2d242ee7da4301390784d4/html5/thumbnails/4.jpg)
All Rights Reserved, Duke Medicine 2007
4
Product Development in the U.S. Ineffective
![Page 5: Building the National Evaluation System for Medical ......US dollars (inflation-adjusted) spent on research and development (R&D) has halved roughly every 9 years since 1950. Scannell](https://reader033.vdocument.in/reader033/viewer/2022042413/5f2d242ee7da4301390784d4/html5/thumbnails/5.jpg)
All Rights Reserved, Duke Medicine 2007
The Digital Revolution An Opportunity for Regulatory Reform
5
![Page 6: Building the National Evaluation System for Medical ......US dollars (inflation-adjusted) spent on research and development (R&D) has halved roughly every 9 years since 1950. Scannell](https://reader033.vdocument.in/reader033/viewer/2022042413/5f2d242ee7da4301390784d4/html5/thumbnails/6.jpg)
All Rights Reserved, Duke Medicine 2007
The Digital Revolution
Impediments to Change
![Page 7: Building the National Evaluation System for Medical ......US dollars (inflation-adjusted) spent on research and development (R&D) has halved roughly every 9 years since 1950. Scannell](https://reader033.vdocument.in/reader033/viewer/2022042413/5f2d242ee7da4301390784d4/html5/thumbnails/7.jpg)
All Rights Reserved, Duke Medicine 2007
The Digital Revolution
Impediments to Change
Clinical
Research Clinical
Practice
Slide with permission from M Krucoff, DUH
![Page 8: Building the National Evaluation System for Medical ......US dollars (inflation-adjusted) spent on research and development (R&D) has halved roughly every 9 years since 1950. Scannell](https://reader033.vdocument.in/reader033/viewer/2022042413/5f2d242ee7da4301390784d4/html5/thumbnails/8.jpg)
All Rights Reserved, Duke Medicine 2007
MDEpiNet Public-Private Partnership
“You can’t break down silos,
but you can connect them.” Christiaan W. Lustig
![Page 9: Building the National Evaluation System for Medical ......US dollars (inflation-adjusted) spent on research and development (R&D) has halved roughly every 9 years since 1950. Scannell](https://reader033.vdocument.in/reader033/viewer/2022042413/5f2d242ee7da4301390784d4/html5/thumbnails/9.jpg)
All Rights Reserved, Duke Medicine 2007
MDEpiNet Public-Private Partnership Who are we?
PARTNERS AHRQ, ACC-NCDR, Avalere, Canadian Agency for Drugs and
Technologies in Health Cardiovascular European Research Center (CERC),
Centers for Medicare and Medicaid Services (CMS), IDEAL Collaboration,
Johnson & Johnson, Lahey Health, MedTech Intelligence, Medtronic, Mercy,
Northgate Public Services, National Center for Health Research, National
Institute for Health and Care Excellence (NICE), Phillips, Phillips Innovation
and You, Society for Vascular Surgery Patient Safety Organization, The TMJ
Association, LTD…. And, GROWING!
![Page 10: Building the National Evaluation System for Medical ......US dollars (inflation-adjusted) spent on research and development (R&D) has halved roughly every 9 years since 1950. Scannell](https://reader033.vdocument.in/reader033/viewer/2022042413/5f2d242ee7da4301390784d4/html5/thumbnails/10.jpg)
All Rights Reserved, Duke Medicine 2007
MDEpiNet Public-Private Partnership The Mission
![Page 11: Building the National Evaluation System for Medical ......US dollars (inflation-adjusted) spent on research and development (R&D) has halved roughly every 9 years since 1950. Scannell](https://reader033.vdocument.in/reader033/viewer/2022042413/5f2d242ee7da4301390784d4/html5/thumbnails/11.jpg)
MDEpiNet Organizational Structure
MDEpiNet Coordinating Center (Duke)
MDEpiNet Science & Infrastructure Center
(Cornell)
MDEpiNet Methodology Center
(Harvard)
MDEpiNet Stakeholder Council
Cardiovascular WG
Orthopedic WG
Additional WGs
Disease-Based Working Groups
Executive Operations Committee
Stakeholder Engagement and Sustainability Committee
International Committee
Publications Committee
Public Programs Committee
Scientific Oversight Committee
From D Marinac-Dabic
![Page 12: Building the National Evaluation System for Medical ......US dollars (inflation-adjusted) spent on research and development (R&D) has halved roughly every 9 years since 1950. Scannell](https://reader033.vdocument.in/reader033/viewer/2022042413/5f2d242ee7da4301390784d4/html5/thumbnails/12.jpg)
All Rights Reserved, Duke Medicine 2007
National Evaluation System (NESMD) Building Blocks
Infrastructure
Analytics
Implementation
![Page 13: Building the National Evaluation System for Medical ......US dollars (inflation-adjusted) spent on research and development (R&D) has halved roughly every 9 years since 1950. Scannell](https://reader033.vdocument.in/reader033/viewer/2022042413/5f2d242ee7da4301390784d4/html5/thumbnails/13.jpg)
All Rights Reserved, Duke Medicine 2007
National Evaluation System (NESMD) Infrastructure
![Page 14: Building the National Evaluation System for Medical ......US dollars (inflation-adjusted) spent on research and development (R&D) has halved roughly every 9 years since 1950. Scannell](https://reader033.vdocument.in/reader033/viewer/2022042413/5f2d242ee7da4301390784d4/html5/thumbnails/14.jpg)
All Rights Reserved, Duke Medicine 2007
Identify & Access Global Data Streams
![Page 15: Building the National Evaluation System for Medical ......US dollars (inflation-adjusted) spent on research and development (R&D) has halved roughly every 9 years since 1950. Scannell](https://reader033.vdocument.in/reader033/viewer/2022042413/5f2d242ee7da4301390784d4/html5/thumbnails/15.jpg)
All Rights Reserved, Duke Medicine 2007
Coordinated Registry Networks (CRNs)
A. Linked complementary registries B. Multiple source structured data extraction
C. Distributed data networks
![Page 16: Building the National Evaluation System for Medical ......US dollars (inflation-adjusted) spent on research and development (R&D) has halved roughly every 9 years since 1950. Scannell](https://reader033.vdocument.in/reader033/viewer/2022042413/5f2d242ee7da4301390784d4/html5/thumbnails/16.jpg)
All Rights Reserved, Duke Medicine 2007
Create a Unified Syntax
![Page 17: Building the National Evaluation System for Medical ......US dollars (inflation-adjusted) spent on research and development (R&D) has halved roughly every 9 years since 1950. Scannell](https://reader033.vdocument.in/reader033/viewer/2022042413/5f2d242ee7da4301390784d4/html5/thumbnails/17.jpg)
All Rights Reserved, Duke Medicine 2007
Incorporate Unique Device Identifier(UDI)
![Page 18: Building the National Evaluation System for Medical ......US dollars (inflation-adjusted) spent on research and development (R&D) has halved roughly every 9 years since 1950. Scannell](https://reader033.vdocument.in/reader033/viewer/2022042413/5f2d242ee7da4301390784d4/html5/thumbnails/18.jpg)
All Rights Reserved, Duke Medicine 2007
Validate Data Accuracy
‘Big Data’
![Page 19: Building the National Evaluation System for Medical ......US dollars (inflation-adjusted) spent on research and development (R&D) has halved roughly every 9 years since 1950. Scannell](https://reader033.vdocument.in/reader033/viewer/2022042413/5f2d242ee7da4301390784d4/html5/thumbnails/19.jpg)
All Rights Reserved, Duke Medicine 2007
National Evaluation System (NESMD) Data Analytics
![Page 20: Building the National Evaluation System for Medical ......US dollars (inflation-adjusted) spent on research and development (R&D) has halved roughly every 9 years since 1950. Scannell](https://reader033.vdocument.in/reader033/viewer/2022042413/5f2d242ee7da4301390784d4/html5/thumbnails/20.jpg)
All Rights Reserved, Duke Medicine 2007
Data Extraction and Longitudinal Trend
Analysis (DELTA)
Uniform Stratified Risk Adjusted
Frequentist Statistical
Process
Control
(SPC)
Stratified
SPC
CUSUM
Logistic Models
SPRT
Propensity Match
Survival Analysis
Bayesian Bayesian
Updating
System
(BUS)
Stratified
Bayesian
Hierarchical
(Bayesian)
Logistic
Regression(HLR)
![Page 21: Building the National Evaluation System for Medical ......US dollars (inflation-adjusted) spent on research and development (R&D) has halved roughly every 9 years since 1950. Scannell](https://reader033.vdocument.in/reader033/viewer/2022042413/5f2d242ee7da4301390784d4/html5/thumbnails/21.jpg)
All Rights Reserved, Duke Medicine 2007
MDEpiNet Strategic Projects Redesigning the Pipeline
App 1 Late-Phase Pre-Market Clinical Trials
App 2 Label Extension & Post-Approval Studies
App 4 Claims-based ‘Performance Goals’
App 3 ‘Dedicated’ Post-Approval Analyses
App 5 Automated Safety Surveillance
![Page 22: Building the National Evaluation System for Medical ......US dollars (inflation-adjusted) spent on research and development (R&D) has halved roughly every 9 years since 1950. Scannell](https://reader033.vdocument.in/reader033/viewer/2022042413/5f2d242ee7da4301390784d4/html5/thumbnails/22.jpg)
All Rights Reserved, Duke Medicine 2007
National Evaluation System (NESMD) Redesigning the Pipeline
![Page 23: Building the National Evaluation System for Medical ......US dollars (inflation-adjusted) spent on research and development (R&D) has halved roughly every 9 years since 1950. Scannell](https://reader033.vdocument.in/reader033/viewer/2022042413/5f2d242ee7da4301390784d4/html5/thumbnails/23.jpg)
All Rights Reserved, Duke Medicine 2007
MDEpiNet PPP A Shared Philosophy
Contact Information
Duke Coordinating Center
Project Manager
![Page 24: Building the National Evaluation System for Medical ......US dollars (inflation-adjusted) spent on research and development (R&D) has halved roughly every 9 years since 1950. Scannell](https://reader033.vdocument.in/reader033/viewer/2022042413/5f2d242ee7da4301390784d4/html5/thumbnails/24.jpg)
All Rights Reserved, Duke Medicine 2007
THANK YOU
J. Matthew Brennan, MD, MPH Interventional Cardiology
Duke Triangle Heart Associates
Assistant Professor of Medicine
Duke University School of Medicine