FDA Mini-Sentinel as a National Resource Jeffrey Brown Harvard - - PowerPoint PPT Presentation

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fda mini sentinel as a national resource
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FDA Mini-Sentinel as a National Resource Jeffrey Brown Harvard - - PowerPoint PPT Presentation

Oct 19, 2022 313 likes •482 views

Opportunities to Expand the Public Health Impact of the Sentinel Initiative FDA Mini-Sentinel as a National Resource Jeffrey Brown Harvard Pilgrim Health Care Institute Harvard Medical School January 31, 2013 info@mini-sentinel.org 1 Outline

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info@mini-sentinel.org 1

Opportunities to Expand the Public Health Impact of the Sentinel Initiative

FDA Mini-Sentinel as a National Resource

Jeffrey Brown Harvard Pilgrim Health Care Institute Harvard Medical School January 31, 2013

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info@mini-sentinel.org 2

Outline

 External engagement  How Mini-Sentinel operates

  • The pieces that make the whole

 Leverage the pieces to accelerate research

  • Example of the NIH Health Care System Collaboratory
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External engagements

 OMOP  Clinical Trials Transformation Initiative  ONC Standards & Interoperability Framework

(Query Health)

 NIH Health Care System Collaboratory  IOM Roundtable on Value and Science-Driven Health

Care

 Academy Health EDM Forum  Other new partners as opportunities present

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Goals of the external engagements

 Know what others are doing to inform our activities  Describe what we are doing to inform their activities  Build resources consistent with national standards

  • Data standards
  • Security
  • Distributed querying

 Inform others of our approaches and lessons learned

  • IOM, AcademyHealth, AMIA, ad-hoc

 Find shared needs across stakeholders

  • PCORI, NIH, CDC, ONC, etc
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How Mini-Sentinel Works

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Mini-Sentinel distributed analysis

1- User creates and submits query (a computer program) 2- Data partners retrieve query 3- Data partners review and run query against their local data 4- Data partners review results 5- Data partners return results via secure network 6 Results are aggregated

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How it works: Coordinating Center

Coordinating Center

  • Governance and Operations

 Policies and contracting  Standard operating procedures  Legal and regulatory compliance  Internal and external engagement  Expectations for participation  Communications

  • Data Integrity and Availability

 Data model management  Data integrity: Fitness for purpose  Refresh management and approval  Data, methods, and use expertise  Immediate information and Data Partner access

  • Query Tools

 Data security and privacy  Querying capabilities  Querying processing and reporting

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Coordinating Center

  • Governance and Operations
  • Data Integrity and Availability
  • Query Tools

Data Partners

  • Data Availability

 Data model and expansion  Data refreshes and integrity  Immediate access to analysts and investigators to assist interpretation of findings

  • Query Responsibilities

 Maintain infrastructure for rapid response  Rapid response based on service level agreement

  • Query Tools

 Testing and review of querying tools  Query tool approval

How it works: Data resources

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Why it works for Mini-Sentinel

Coordinating Center Data Partners Mini-Sentinel needs

  • Responsiveness

Frequent rapid response queries Quickly modify existing query types Design / test new query types Design / test new data resources Determine fitness of data for new uses Investigate unanticipated results

  • Data Partner Commitment

Data always available for use Guaranteed response times

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Mini-Sentinel needs

  • Responsiveness
  • Data Partner Commitment

Tightly Coupled Network Daily interaction between Coordinating Center and Data Partners Coordinating Center Data Partners

Why it works for Mini-Sentinel

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How (and Why) to Leverage It To Build Other Networks

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It’s really hard to build a network from scratch

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Multiple Networks Sharing Infrastructure

FDA Mini-Sentinel

Health Plan 2 Health Plan 1 Health Plan 5 Health Plan 4 Health Plan 7 Hospital 1 Health Plan 3 Health Plan 6 Health Plan 8 Hospital 3 Health Plan 9 Hospital 2 Hospital 4 Hospital 6 Hospital 5 Registry 1 Research Dataset 3 Research Dataset 1 Registry 2 Research Dataset 4 Research Dataset 2

Other Network NIH

 Partner Organizations can choose to participate in

multiple networks

 Networks can leverage existing data, query tools,

program libraries

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NIH Health Care Systems Collaboratory

Home of the NIH Distributed Research Network

A Virtual Home for Knowledge about Pragmatic Clinical Trials using Health Systems

Millions of lives. Strong collaborations. Privacy first.

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NIH Distributed Research Network (as envisioned)

Health Plan 2 Health Plan 5 Hospital 3 Registry 1 Research Dataset 1

NIH Distributed Network Coordinating Center

Designed to allow use of existing Mini-Sentinel and others tools

  • Can use many data types, e.g., EHR, claims, registries
  • Can use many data models, e.g., Mini-Sentinel, i2b2, OMOP
  • Can use existing querying tools, e.g., Mini-Sentinel modular programs

Studies involve negotiation, planning, and investigation of data’s

fitness for purpose

Registry 2 Research Dataset 2 Hospital 6

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Thank you!