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MDEPINET INTERNATIONAL REGISTRY CONSORTIA, DATA AND MODELS
Danica Marinac-Dabic, MD, PhD, MMSc, FISPE
Director, Division of Epidemiology, FDA/CDRH
American Joint Replacement Registry Australian Orthopaedic Assoc. RegistryAustrian Arthroplasty Register California Joint Replacement RegistryCanadian Joint Replacement Registry England & Wales National Joint RegistryHealthEast Joint Registry Hip and Knee Registry of the NetherlandsHospital for Special Surgery Italian Register of Orthopaedic ImplantsKaiser Permanente Massachusetts General HospitalMayo Clinic New England Baptist Hospital RegistryNew Zealand Joint Register Norwegian Arthroplasty RegisterOrthoCarolina Portuguese Arthroplasty RegisterRush University Med. Ctr. Joint Registry Slovakian Arthroplasty RegisterScFCOT THA Registry Swedish Hip and Knee RegistersScottish Arthroplasty Project UMass FORCE RegistryVirginia State Registry Western Slope Study Group
2011 ICOR Inaugural Meeting at FDA
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Global MDEpiNet
Future MDEpiNet Chapter
Academic Centers
Data Sources
Existing MDEpiNet Chapter
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Public-Private-Partnership• Over 130 partners• Over 100 registries • Over 750 clinical experts • Over 100 methodologists• National and State claims data• International EHRs• Integrated Health Care Delivery Systems (e.g. Kaiser)• Collaborations with PCORNet and Sentinel • HIVE collaborative space with petabytes of storage space
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MDEpiNet Coordinated Registries Network (CRNs)
National• Orthopedics CRN• Vascular CRN –VISION• Neurology CRN – DAISI • Gastrointestinal (GI) CRN – Obesity• HIFU CRN• Robotic Surgery CRN• Plastic Surgery – NBIR/PROFILE • Women’s Health Technologies –
COMPARE-UF, NPFD, Sterilization Devices
International• International Consortium
Orthopedics Registries (ICOR)• International Consortium
Vascular Registries (ICVR)• International Consortium of
Cardiovascular Registries (ICCR)• International Collaboration of
Breast Registries Activities (I-COBRA)
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Impact – selected examples
• National Medical Device Registry Task Force Report
• Over 125 papers
• Significant contributions to:– 2 IMDRF Registry General Principles documents
(published)
– IMDRF Registry Assessment tool for regulatory decision making (new)
• Innovative Methodologies for TPLC Evaluationwww.fda.gov
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Public-Private-Partnership
www.fda.gov
http://mdepinet.org/who-we-are/
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2010 2011 2012 2013 2014 2015 2016 2017
MDEpiNetLaunch
International Consortia(e.g. ICOR, ICCR)
Reports:• Planning
Board • Registry Task
Force • IMDRF
Started May 9-10, 2011 Meeting Organizing CommitteeCo: chairs:Art Sedrakyan, Cornell, HSS and FDA Danica Marinac-Dabic, FDA Office of Surveillance & Biometrics
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Mission and Goals
• To advance the research and improve evidence (including CER) for the safety and effectiveness of orthopedic devices and procedures – Develop strategic plan for establishment of scientific infrastructure
for collaboration– Harmonizing the data among US based and international
orthopedic registries– Implementing a distributed data analysis system and conduct
studies to monitor the safety and effectiveness of various orthopedic devices
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International Consortium of Orthopedic Registries (ICOR)
• Comparative effectiveness / safety studies (27 papers published in JBJS,)
• Catalyzed the development of ICOR-USA/ Ortho CRN
• Informed the International Medical Device Regulators Forum (IMDRF) Registry Working Group
• Served as a model for new International Consortia of Vascular, Transcatheter Valve, and Breast Implant registries
Partnership: 29 Registries, (8 contributing data)
Over 5,200,000 implants
Methods: Common Data Model to combine
and de-identify data
UDI Promotion: Global Clinically-Meaningful
Attributes Database for Hips and Knees
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ICOR model
• ICOR helps to enhance and harmonize the registry data worldwide
• Supports CER research to understand the safety and effectiveness of various devices and procedures
• Registries maintain full control– Who will use their data– Research they choose to participate in– Type of data that they can provide
• At intermediate stage only distributed data analyses are conducted
• Surveillance platform is being established
Analytical code
Frequencies, Crosstabs, Cox regression results, survival probabilities
Registry 1
Registry 2
Registry 3
ICOR Coordinating Center
• Write & distribute code• Aggregate findings across
• Support Registry leads
ICOR Distributed Network Model
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