1. DEVELOPMENT OF Coordinated Registry NetworkS: BENEFITS to THE FDA MISSION
Danica Marinac-Dabic, MD, PhD, MMSc, FISPE
Director, Division of Epidemiology,
FDA/Center for Devices and Radiological Health

2. Summary Contextual building blocks: Via “Nets” to NEST
Coordinated Registry Networks (CRNs) and MDEpiNet’s CRN Community of Practice (COP)
Vascular CRN: Example of partnership effort VISION/RAPID
How these initiatives fit together?

3. FDA RWE Guidance 2010 2011 2012 2013 2014 2015 2016 2017 MDEpiNet
THE VISION FOR NATIONAL SYSTEM
LAUNCHED
FDA 4- day Public Meeting
Day 1. Launch of FDA strategy
Day 2. MDEpiNet Annual
Days 3-4. Registries
Reports:
Planning Board
MDEpiNet Registry Task Force
IMDRF
FDA RWE Guidance
International Consortia
(e.g. ICOR, ICCR)
MDEpiNet Launch
2010
2011
2012
2013
2014
2015
2016
2017
Develop and test drive novel methods and scientific infrastructure for device evidence generation synthesis and appraisal nationally and internationally
MDEpiNet
Methodology
Center at
Harvard
MDEpNet Science
and
Infrastructure
Center at Cornell
MDEpiNet
Launched
CRN
Community
of Practice

4. VISION CRN 2010 2011 2012 2013 2014 2015 2016 2017 MDEpiNet Launched
THE VISION FOR NATIONAL SYSTEM
LAUNCHED
FDA 4- day Public Meeting
Day 1. Launch of FDA strategy
Day 2. MDEpiNet Annual
Days 3-4. Registries
Reports:
Planning Board
MDEpiNet Registry Task Force
IMDRF
International Consortia
(e.g. ICOR, ICCR)
MDEpiNet Launch
2010
2011
2012
2013
2014
2015
2016
2017
VISION CRN
Develop and test drive novel methods and scientific infrastructure for device evidence generation synthesis and appraisal nationally and internationally
MDEpiNet
Methodology
Center at
Harvard
MDEpNet Science
and
Infrastructure
Center at Cornell
MDEpiNet
Launched
CRN
Community
of Practice

6. 2015 Medical Device Registry Task Force recommendations to FDA
Coordinated Registry Networks (CRN) Principles:
Link complementary sustainable registries/e-repositories (Professional society registries, EHRs, Claims data)
TPLC as a true continuum of structured “real world” evidence
“Dual purpose” existing site-base work flow
Krucoff MW, Normand SL et al, JAMA 2015

7. CRNs – The Key Concepts
Data capture embedded in routine practice (better, faster , cheaper)
Strategically coordinated/harmonized within the ecosystem
Clinical core data sets (including PRO where possible)
Informatics solutions (including UDI, SDC)
Sustainability (value propositions, ROI, maturity models)
Network
Term was ” Coined” for registries - but applies beyond
Include national and international/global opportunities

8. CRNs Build on International Models and Standards
“Organized system that continuously and consistently collects relevant data in conjunction with routine clinical care, evaluates meaningful outcomes and comprehensively covers the population defined by exposure to particular device(s) at a reasonably generalizable scale (e.g. international, national, regional, and health system)’ with a primary aim to improve the quality of patient care”.
The IMDRF definition of medical device registry approximates the definition of CRN.

9. Strategically Coordinated Registry Networks (CRNs)
National
International
Ortho CRN
Vascular CRN – VISION
Cardiac CRN
Neurology CRN – DAISI
Gastrointestinal CRN – Obesity
SPARED CRN – Prostate ablation
Robotic Surgery CRN
TMD/TMJ
VANGUARD
Women’s Health Technologies – Uterine Fibroids, Pelvic Floor Disorders, Sterilization Devices,
Breast Implants - NBIR
Abdominal Hernia CRN
International Consortium Orthopedics Registries (ICOR)
International Consortium Vascular Registries (ICVR)
International Consortium of Cardiac Registries (ICCR)
International Collaboration of Breast Registries Activities (I-COBRA)
Development of 11 national CRNs is underway
Four international consortia

10. In 2018 MDEpiNet has launched CRN Community of Practice
To create a learning community where Coordinated Registry Networks (CRNs) can share lessons learned and best practices.
CRN’s will continue to produce RWE to support regulatory decision making, essential for the next round of MDUFA negotiation
Currently 15 CRN under development, which will cover the majority of implantable devices
MDEpiNet is helping CRN mature (produce evidence to evaluate devices) through a Community of Practice (COP, national and international)
Share lessons learned
Develop maturity models
Minimum core data sets
Develop informatics underpinnings

11. RAPID/VISION: A Scalable Framework to Efficiently Conduct Real-world Enabled Vascular Clinical Trials  
Two MDEpiNet projects VISION (led by Cornel) and RAPID (led by Duke) were launched to complement each other
VISION - to develop National Vascular Implants Surveillance and Outcomes Network by linking VQI registry to claims and other data sources for longitudinal assessment
RAPID - to developed a core data element (CDE) set informed by multiple registries, EHR systems, and stakeholders.
Leveraging both efforts the SPEED pilot is now being designed to demonstrate how clinical trials sufficient to support regulatory decision-making can be efficiently implemented into existing healthcare systems for expanding the indications
The SPEED trial that will involve patients from the VQI registry with (estimated prospective and 8400 retrospective patients data and 2940 patients with 1 year follow-up data available for developing Objective Performance Criteria – OPCs
The projects leverage the GUDID Database to enable comparative effectiveness research of peripheral vascular technologies.
It will involve data refinement and analyses to develop contemporary OPCs using RWE, data sharing with industry stakeholders for potential labeling modification (e.g., longer lesions, heavy calcified lesions, diabetic patients).
The new paradigm is that industry will have access to the conglomerate of data plus their own data. Thus, if pre-specified statistical plan is met for a given subgroup analysis population as per examples above, a labeling modification could be requested/granted.

12. Evaluation of Medical Device Postmarket Landscape
ARRA, HITECH Acts.
125 million lives captured in mini-Sentinel.
Establishment of MDEpiNet.
Final Rule for UDI.
Evaluation of UDI within claims and EHR.
Linkage of device registries with other healthcare data sources.
Use of distributed data networks for surveillance.
Device registries and UDI fully integrated into patient healthcare dataset.
Patient info able to be tracked across datasets via “hashing” or “fuzzy logic” linking.
Postmarket infrastructure allows most evaluation via automatic data collection.
In rare instances where additional data needed, patient surveys and disease-based registries created.
2029-future
Continue to innovate and utilize novel methodologies and new technologies to better understand performance and clinical outcomes of medical devices in the postmarket.
Ongoing evaluation of postmarket landscape used to provide context for benefit-risk balance for newly developed devices.
Medical Device Reports
Enhanced Surveillance
De Novo Data Collection Decreasing –
Additional data sources available with advent of UDI, integration of registries into long-term data, and newly developed data linking capabilities
De Novo Data Collection
Sentinel Initiative –
* Signal Refinement for identified potential public health concerns
* Initially claims data, will also include electronic healthcare records
Evaluation of Medical Device Postmarket Landscape
Administrative and Claims Data
Postmarket Infrastructure and Novel Methodologies Systematically Developed and Enhanced via MDEpiNet
Electronic Healthcare Records
Use of EHR and Claims Data –
* Most data currently captured in registries is also captured by the facility at the time of the procedure.
* Incorporation and utilization of this data from the EHR and claims data allows for better understanding of medical device use in the context of other healthcare utilization and provides additional data regarding patients outcomes.
Alternative Data Collection for Registries –
* Utility of registries increases with accurate and timely data collection.
* Collecting data from EHRs or directly from patients will enhance the long-term capabilities while removing burden from healthcare facilities.
Device-Based Registries
International Consortium of Orthopedic Registries –
* 3 million lives with orthopedic procedures captured globally
* Follow-up and outcomes assessed via common data model
Secondary analysis of previously collected data –
e.g. meta-analysis, cross-design evidence synthesis
Disease-Based Registries
2009
2014
2019
2024
2029
2034

13. Thank You!