Danica Marinac-Dabic, MD, PhD, MMSc, FISPE Director, Division of Epidemiology, FDA/CDRH MDEPINET INTERNATIONAL REGISTRY CONSORTIA, DATA AND MODELS
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1 Danica Marinac-Dabic, MD, PhD, MMSc, FISPE Director, Division of Epidemiology, FDA/CDRH MDEPINET INTERNATIONAL REGISTRY CONSORTIA, DATA AND MODELS 1
2 2011 ICOR Inaugural Meeting at FDA American Joint Replacement Registry Austrian Arthroplasty Register Canadian Joint Replacement Registry HealthEast Joint Registry Hospital for Special Surgery Kaiser Permanente Mayo Clinic New Zealand Joint Register OrthoCarolina Rush University Med. Ctr. Joint Registry ScFCOT THA Registry Scottish Arthroplasty Project Virginia State Registry Australian Orthopaedic Assoc. Registry California Joint Replacement Registry England & Wales National Joint Registry Hip and Knee Registry of the Netherlands Italian Register of Orthopaedic Implants Massachusetts General Hospital New England Baptist Hospital Registry Norwegian Arthroplasty Register Portuguese Arthroplasty Register Slovakian Arthroplasty Register Swedish Hip and Knee Registers UMass FORCE Registry Western Slope Study Group
3 Global MDEpiNet Existing MDEpiNet Chapter Future MDEpiNet Chapter Academic Centers Data Sources 3
4 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 4
5 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) 5
6 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 Evaluation 6
7 Public-Private-Partnership 7
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9 MDEpiNet Launch International Consortia (e.g. ICOR, ICCR) Reports: Planning Board Registry Task Force IMDRF
10 Started May 9-10, 2011 Meeting Organizing Committee Co: chairs: Art Sedrakyan, Cornell, HSS and FDA Danica Marinac-Dabic, FDA Office of Surveillance & Biometrics
11 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 11
12 International Consortium of Orthopedic Registries (ICOR) UDI Promotion: Global Clinically-Meaningful Attributes Database for Hips and Knees Partnership: 29 Registries, (8 contributing data) Over 5,200,000 implants Comparative effectiveness / safety studies (27 papers published in JBJS,) Catalyzed the development of ICOR-USA/ Ortho CRN Methods: Common Data Model to combine and de-identify data 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 12
13 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 13
14 ICOR Distributed Network Model ICOR Coordinating Center Write & distribute code Aggregate findings across Support Registry leads Analytical code Frequencies, Crosstabs, Cox regression results, survival probabilities Registry 1 Registry 2 Registry 3
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