Danica Marinac-Dabic, MD, PhD, MMSc, FISPE Director...

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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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Danica.Marinac-Dabic@fda.hhs.gov