MDEpiNet: Accomplishments and Capabilities Danica Marinac-Dabic, MD, PhD, MMSc, FISPE Director, Division of Epidemiology, CDRH/FDA On Behalf of MDEpiNet
Summary • Brief MDEpiNet history/in the context of FDA vision for the national system • Scalable Domains • Examples of Partnerships/Capabilities: A Strategic look 2
THE VISION FOR NATIONAL SYSTEM LAUNCHED Reports: FDA 4- day Public • Planning Meeting Board Day 1. Launch of • MDEpiNet FDA strategy International Registry Task Day 2. MDEpiNet Consortia Force MDEpiNet Annual (e.g. ICOR, ICCR) • IMDRF Launch Days 3-4. Registries 2010 2011 2012 2013 2014 2015 2016 2017 MDEpiNet MDEpiNet Develop and Partnership Methodology test drive Coordinating Center at novel methods Harvard Center at Duke and scientific infrastructure MDEpNet Science for device and evidence Infrastructure generation Center at Cornell synthesis and appraisal nationally and internationally 3
MDEpiNet – Quick Facts Over 130 partnering public and private sector organizations from the device • ecosystem globally (academia, professional associations, registries, industry, patient organizations, health systems and more); Access to over 30 million patient/device Over 100 national/regional registries from 37 countries; • 11 National CRNs and 4 International Registry Consortia; • encounters in registries Over 750 clinical experts across clinical areas; • Over 150 methodologists (statisticians, epidemiologists, data scientists, • informaticians, health care researchers and more); Access to hundreds of millions of claims records • National and State claims data (e.g. CMS, NY SPARCS) • National and International EHRs (e.g. PCORNet, Sentinel, VA, UK, Australia) • Integrated Health Care Delivery Systems (e.g. Kaiser) • Over 60 demonstration projects including projects with PCORNet and Sentinel High Performance Integrated Virtual Environment (HIVE) collaborative space • with petabytes storage space and analytical tools 4
www.fda.gov
Global MDEpiNet Existing MDEpiNet Chapter Academic Centers Future MDEpiNet Chapter Data Sources 6
Registry Development MDEpiNet National/International Consortia Development Infrastructure Electronic Device Data Capture (UDI) Work Task Force -Coordinated Registry Networks(CRNs) PASSION Initiative Streams Active Surveillance Comparative Effectiveness Evidence Synthesis Claims Validation Methods Linkage with other Data Sources Big Data Analytics Translational Epidemiology Augmenting Registries with PROs and Explant Analysis for Precision Medicine Assessing Minimally Important Difference (MID) for implants Patient Engagement Patient and Family Engagement Committee Patient-led Device/Disease Specific Round Table 7
Scalable Domains of MDEpiNet Tools Infrastructure Methodology Partnerships 8
Tools 9
Data Extraction and Longitudinal Track Analysis (DELTA) • DELTA software was produced by collaborative work and support from FDA, NLM, Harvard and Leahy at Tufts. It was first validated on outcomes and clinical trial databases and shown to • efficiently identify very low frequency events utilizing an array of Bayesian and frequentist inference methods. It now supports multiple simultaneous analyses, tracking the accumulating • experience of multiple devices, while monitoring multiple independent datasets simultaneously. • Scalability demonstrated through series of retrospective then prospective studies: a. Health Care System Level - including Partners Healthcare in Boston b. State level – including MA Angioplasty Registry sites linked to Massachusetts inpatient Claims DB, and MA Vital Statistics c. National level – NCDR Cath PCI registry ( e.g. vascular closure devices). By the end of the year it is expected to be installed in ICD registry and TVT • registry Earlier this year – DELTA became an open source available to all • stakeholders at no cost. 10
UDI as a Key Component of MDEpiNet Methodology Work UDI – part of Real World Data RAPID Registry Assessment of Peripheral Interventional Devices http://mdepinet.org/rapid/ Use DI to pull data from GUDID and auto-populate fields BUILD Building UDI Into Longitudinal Data Sets for Medical Device Evaluation CARDIOVASCULAR DEVICES See http://mdepinet.org/build/ 11
Public HIVE as MDEpiNet Resource maxi-HIVE mini-HIVE Public-HIVE Public-elastic HIVE location: White Oak /CDRH HPC storage: ~2 Petabytes location: White Oak/CBER server room location: GWU Dr Mazumder’s lab location: ColonialOne/Ashburn cpu: 3000 cores, extensible to storage: ~1 Petabytes storage: ~300 Terabytes datacenter 5000 cpu: ~1500 cores cpu: ~400 cores storage: extensible to Petabytes wan : 10Gb Þ Internet2 wan: 10Gb wan: 1Gb cpu: +1000 cores lan: 40Gb Þ Infiniband lan: 56 GB lan: 10 GB wan : 10Gb Þ Internet2 platform: metal + SunGrid platform: barebone metal platform: metal lan: 10Gb Þ Infiniband platform: Lustre open source goal: ATO approved regulatory goal: research and scientific NGS portal with goal: support and integrate wider next-gen support platform for cutting edge production quality tools community of researchers into HIVE goal: to become extensibility long term storage and large process, allow access to cutting edge platform for public HIVE users scale computations; to support regulatory complaint tools and standards, for their large scale regulatory submissions for NGS perform pilot free projects with computational needs for large and standardization portal for academic, industry and government clinical research projects. NGS evidence submissions entities to promote and ease the access to novel NGS techniques. To incorporate HIVE into education. HIVE is an ecosystem of HIVE-ZONE hardware/software/expertise allowing developers and users to implement variety location: virtual cloud of infrastructures/ tools/ visual interfaces storage: ~extensible Amazon manipulate large amount of complex data cpu: ~extensible wan: ~extensible through sophisticated computational lan: ~extensible pipelines in this “sandbox” like environment . goal: support large scale sporadic surge usage patterns for extra large clinical computations through openFDA .gov initaitve for FDA and for openHIVE platform for wider scientific research and education community. 12
Methods 13
Examples of Expertise Causal inference with high-dimensional, complex, observational • data: – Bayesian propensity score using regularizing prior distributions – Robust likelihood approaches for comparing many devices via Super Learning – Making better use of claims codes via Bayesian hierarchical prior distribution Meta-analysis of individual participant data for identification of • device-effect heterogeneity and for OPC construction Device surveillance that incorporate regulator loss functions • Handling missing data in CRNs that use a distributed system • Common Data Elements (CDE) • Distributed models • And much more!!! • 14
Infrastructure 15
CRNs • Approach is to facilitate and/or leverage national investments in registries and other relevant data Focus is to provide timely systems (dual purposing) to create ‘ National Medical information on device Device Evaluation System on a fairly immediate basis, greatly minimizing the cost or development resources experiences for decision needed ’ making by patients, – Major ‘Quality and safety’ registries initiated by professional societies, physicians, regulators and all states, healthcare systems, NIH/AHRQ, other – CMS claims including Part A,B,C,D other stakeholders – Commercial claims – PCORI CDRNs – All payer State databases – Comprehensive EHRs 16
Evolving CRN Portfolio National International Ortho CRN (aka ICOR- USA • International Consortium Orthopedics • • Vascular CRN – VISION Registries (ICOR) • Cardiac CRN International Consortium Vascular • Neurology CRN – DAISI • Registries (ICVR) Gastrointestinal CRN – Obesity • International Consortium of Cardiac • SPARED CRN – Prostate ablation • Registries (ICCR) • Robotic Surgery CRN • International Collaboration of Breast • TMD/TMJ Registries Activities (I-COBRA) VANGUARD • Women’s Health Technologies – • Uterine Fibroids, Pelvic Floor Disorders, Sterilization Devices, Breast Implants (NBIR pilot under • way) • Abdominal Hernia CRN 17
Coordinated Registry Network (CRNs) as part of NEST Address ecosystem questions efficiently Government Patients Health Care Providers Harmonization/Interoperability ONC Device Industry States EHR Data Registry Registry Registry Structured Data Capture (SDC) EHR Vendors Researchers Hospitals Integrated www.fda.gov Delivery Systems 18
Selected Data Sources • 10-20 years of clinical registries data (national/international) • Hospital discharge data • State data • Medicare/Medicaid data • AHRQ data sources • Truven data • RoPR - Searchable central listing of patient registries • Gene Expression Omnibus (GEO/NCBI) • Ingenuity Pathway Analysis (IPA) • Electronic Medical Records and Genomics Network at the • National Human Genome Research Institute (eMERGE/NHGRI) including MCRI – Marshfield Clinic Research Institute ) • And more! 19
Partnerships 20
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