Danica Marinac-Dabic MD, PhDDirector, Division of Epidemiology

Contemporary Efforts in Gap Analysis/Research Prioritization Space

Regulatory Context

MDEpiNet Partnership

Two Examples: Orthopedics; MCM

Next Steps: ◦

Work in Progress: Development of Formal Framework

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Multiple stakeholders and ongoing efforts (AHRQ, PCORI, Cochrane, NIH Consensus Development, MDEpiNet )

Criteria for gaps identification and prioritization

Multiple methods used

Consensus?

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Research questions are readily available

Regulatory/Public Health

Driving forces for prioritization

Leverage existing efforts

Transparency and confidentiality

Opportunities of Public Private Partnerships

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FDA MDEpiNet InitiativeFDA MDEpiNet Initiative

To develop national/international  infrastructure and innovative 

methodological approaches for conducting  robust studies and surveillance to improve  medical device safety and effectiveness 

understanding throughout the device life  cycle through Public Private Partnership 

with academia and other stakeholders . 

MISSION

INFRASTRUCTURE

PARTNERSHIP

TPLC GLOBAL

PATIENT CENTERED

Co-Principal Investigators:Sharon-Lise Normand, PhD

Harvard Medical School & Harvard School of Public Health

Frederic S. Resnic, MD MSc Lahey Clinic Medical Center & Tufts University School of Medicine

Harvard Medical School Harvard  School of 

Public HealthLahey Clinic  Medical 

Center

Principal Investigator:Art Sedrakyan, MD, PhD Art Sedrakyan, MD, PhD

Associate ProfessorWeill Cornell Medical College

Director of Comparative Effectiveness Research Program

Principal Investigator: Mitchell W. Krucoff, MD, FACC

Professor, Medicine/CardiologyDuke University Medical Center

Director, Cardiovascular Devices UnitCo-Director, CSRC

Duke Clinical Research Institute

Cardiac Safety Research Consortium

Cardiac Safety Research Consortium

Research Question

Systematic Review of Evidence

StakeholderEngagement

Transformation to Goals

Identification of Gaps

ReportReportFDA/ FDA/

MDEpiNetMDEpiNetTeam Team

Public Public meeting/meeting/

workshopworkshopFDA/FDA/

stakeholder stakeholder RFARFA

Proposed Approaches

FDA/FDA/MDEpiNetMDEpiNet

Team Team

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Imposed by the FDA at the time of approval

Focus on long–term performance and clinical outcomes associated with ceramic on ceramic hips in a real-world setting

Lack of adequate postmarket infrastructure

Burden of individual studies

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Scientific framework for International Consortium of Orthopedic Registries (ICOR)

Inaugural Public meeting held at FDA

29 registries (14 nations)

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The ICOR Project UpdatesThe ICOR Project Updates◦

Developed a strategic plan for establishment of scientific infrastructure for collaboration: www.icor-initiative.org◦

In process of signing all MOUs◦

Knee implant database harmonized among pilot registry participants (AU, Sweden, Kaiser) and now available to all registry partners to test, implement and enhance◦

Hip implant database in process (AU, Norway, Kaiser)◦

Distributed data analysis system is implemented for two comparative effectiveness studies: hip bearing surface and mobile knee platforms for hip and knee replacements.

International Steering Committee

Worldwide framework for gap analysis and research prioritization

Internet portal –

ICOR Website

Forum for sharing experience with introduction of new technology

Distributed networks

Methodology development

Furthering the system

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Limited safety/effectiveness data now or during CBRN

Recent natural disasters help us focus: ◦

Hurricanes (Katrina, Sandy) ◦

Earthquakes (Asia, Haiti) ◦

Nuclear (Japan, Chernobyl)

Make incremental steps to evaluate performance and advance innovation

Learn how disasters affect devices including implants

Conduct Systematic search of peer-reviewed and gray literature:

Hand search the Tables of Contents of disaster-related journals-

Disaster Info

Management Research Center

GrayGray--literature searches on the literature searches on the WebWeb

The  evidence framework

Systematic appraisal of premarket and other available evidence

New real world studies to fill the gaps/ Research

consortium development

Translate the results for decision making and dissemination for patients

and physicians

Combined Evidence

What shall we look for: Device type? Disaster What shall we look for: Device type? Disaster type?, Disastertype?, Disaster--related problem or threat? related problem or threat? Intervention type?Intervention type?

Talk with experts with first-hand knowledge of

disaster effect on

the performance◦

Clinicians, administrators, hospital technicians with experience in responding to catastrophic incidents

Interviewing via Webinars and formal telephone interviews

Some international issues need on-ground investigation but we lack resources for visits

Base on AHRQ surge model

Evaluate device functionality on outcomes:◦

Need for transfers when facing widespread device failure

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Systems for repair/replacement of devices during & after catastrophic events (emphasis on supply chain life & morbidity)

Steps include:◦

Scenario development◦

Specification of failure modes◦

Use of discrete event simulation software package -create familiar user interface and experience

In collaboration with In collaboration with Brookings Institution Brookings Institution

Discuss the gaps in data, methodology needs ◦

prioritize pressing issues

Hold multi-stakeholder expert discussions

Develop white papers

Unifying framework -

Reflects the need continuum of evidence in regulatory setting

Comprehensive

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Systematic identification of all relevant data

Focused

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around device content areas

Expertise driven –

FDA/MDEpiNet

Dynamic -

integration, synthesis and evaluation of data

Patient centered –

reflects patient needs

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Working with MDEpiNet Partners to formalize the process for gap analysis/research prioritization within the Public Private Partnership

Transparency

danica.marinac-dabic@fda.hhs.gov

(301) 796-6689

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