National Cardiovascular National Cardiovascular Research Infrastructure (NCRI)Research Infrastructure (NCRI)

Summary Slide SetSummary Slide Set

National Cardiovascular National Cardiovascular Research Infrastructure (NCRI)Research Infrastructure (NCRI)

Summary Slide SetSummary Slide Set

May 5, 2010May 5, 2010May 5, 2010May 5, 2010

Clinical Research in CrisisClinical Research in CrisisClinical Research in CrisisClinical Research in Crisis

Most clinical guideline recommendations founded only Most clinical guideline recommendations founded only upon “expert consensus”upon “expert consensus”

Repetitive creation and disassembly of operational Repetitive creation and disassembly of operational infrastructure for individual trialsinfrastructure for individual trials

Only 10% of sites enroll 40% of patients in large Only 10% of sites enroll 40% of patients in large cardiovascular clinical trials. cardiovascular clinical trials.

15% of sites obtaining IRB approvals never enroll anyone. 15% of sites obtaining IRB approvals never enroll anyone.

Fragmented data collection prevents true interoperability, Fragmented data collection prevents true interoperability, costing $156 million annually in data transfers.costing $156 million annually in data transfers.

Most clinical guideline recommendations founded only Most clinical guideline recommendations founded only upon “expert consensus”upon “expert consensus”

Repetitive creation and disassembly of operational Repetitive creation and disassembly of operational infrastructure for individual trialsinfrastructure for individual trials

Only 10% of sites enroll 40% of patients in large Only 10% of sites enroll 40% of patients in large cardiovascular clinical trials. cardiovascular clinical trials.

15% of sites obtaining IRB approvals never enroll anyone. 15% of sites obtaining IRB approvals never enroll anyone.

Fragmented data collection prevents true interoperability, Fragmented data collection prevents true interoperability, costing $156 million annually in data transfers.costing $156 million annually in data transfers.

NCRI MissionNCRI MissionNCRI MissionNCRI Mission

Integrate existing resources to efficiently execute large Integrate existing resources to efficiently execute large simple clinical research projectssimple clinical research projects

Site recruitment and education (CTNBP)Site recruitment and education (CTNBP) Randomization (DCRI)Randomization (DCRI) Data collection (NCDR)Data collection (NCDR) Data standards (CDISC, HL7) Data standards (CDISC, HL7) Guideline development (ACC)Guideline development (ACC)

The Infrastructure and operations requirements go far The Infrastructure and operations requirements go far beyond software and database programmingbeyond software and database programming

Integrate existing resources to efficiently execute large Integrate existing resources to efficiently execute large simple clinical research projectssimple clinical research projects

Site recruitment and education (CTNBP)Site recruitment and education (CTNBP) Randomization (DCRI)Randomization (DCRI) Data collection (NCDR)Data collection (NCDR) Data standards (CDISC, HL7) Data standards (CDISC, HL7) Guideline development (ACC)Guideline development (ACC)

The Infrastructure and operations requirements go far The Infrastructure and operations requirements go far beyond software and database programmingbeyond software and database programming

NCRI MissionNCRI MissionNCRI MissionNCRI Mission

Adding randomization to data acquisition harnesses Adding randomization to data acquisition harnesses the NCDR backbone to create an efficient platform the NCDR backbone to create an efficient platform for large simple randomized clinical trials. for large simple randomized clinical trials.

Extend the NCDR mission from measuring Extend the NCDR mission from measuring healthcare quality to healthcare quality to

providing key evidence to inform evolving evidence-providing key evidence to inform evolving evidence-based practice guidelinesbased practice guidelines

enhancing patient safety through post market enhancing patient safety through post market surveillance and pharmacovigilancesurveillance and pharmacovigilance

Adding randomization to data acquisition harnesses Adding randomization to data acquisition harnesses the NCDR backbone to create an efficient platform the NCDR backbone to create an efficient platform for large simple randomized clinical trials. for large simple randomized clinical trials.

Extend the NCDR mission from measuring Extend the NCDR mission from measuring healthcare quality to healthcare quality to

providing key evidence to inform evolving evidence-providing key evidence to inform evolving evidence-based practice guidelinesbased practice guidelines

enhancing patient safety through post market enhancing patient safety through post market surveillance and pharmacovigilancesurveillance and pharmacovigilance

Specific AimsSpecific AimsSpecific AimsSpecific Aims

Aim 1: Expanding NCDR Site Capability Aim 1: Expanding NCDR Site Capability

Aim 2: Facilitate standards and interoperability for Aim 2: Facilitate standards and interoperability for cardiovascular clinical research founded on NCDR cardiovascular clinical research founded on NCDR and CDISC.and CDISC.

Aim 3: A large simple randomized clinical trials Aim 3: A large simple randomized clinical trials platform to solicit and advance research questions platform to solicit and advance research questions that fill critical evidence gaps.that fill critical evidence gaps.

Aim 4: An integrated electronic repository of tools Aim 4: An integrated electronic repository of tools and programs to assist clinical research site and programs to assist clinical research site activities accessible by a Web-based informatics activities accessible by a Web-based informatics infrastructure infrastructure

Aim 1: Expanding NCDR Site Capability Aim 1: Expanding NCDR Site Capability

Aim 2: Facilitate standards and interoperability for Aim 2: Facilitate standards and interoperability for cardiovascular clinical research founded on NCDR cardiovascular clinical research founded on NCDR and CDISC.and CDISC.

Aim 3: A large simple randomized clinical trials Aim 3: A large simple randomized clinical trials platform to solicit and advance research questions platform to solicit and advance research questions that fill critical evidence gaps.that fill critical evidence gaps.

Aim 4: An integrated electronic repository of tools Aim 4: An integrated electronic repository of tools and programs to assist clinical research site and programs to assist clinical research site activities accessible by a Web-based informatics activities accessible by a Web-based informatics infrastructure infrastructure

American Recovery & Reinvestment Act of 2009 American Recovery & Reinvestment Act of 2009 (ARRA)(ARRA)

NIH Research and Research Infrastructure “Grand NIH Research and Research Infrastructure “Grand Opportunities” (GO) initiativeOpportunities” (GO) initiative

““Substantially accelerate comparative effectiveness Substantially accelerate comparative effectiveness research, advance methods development and priority research, advance methods development and priority setting, and forge robust infrastructure to support the setting, and forge robust infrastructure to support the conduct of comparative effectiveness research.”conduct of comparative effectiveness research.”

NHLBI Award 1RC2HL101512-01NHLBI Award 1RC2HL101512-01

$2.6M over 2 years$2.6M over 2 years

American Recovery & Reinvestment Act of 2009 American Recovery & Reinvestment Act of 2009 (ARRA)(ARRA)

NIH Research and Research Infrastructure “Grand NIH Research and Research Infrastructure “Grand Opportunities” (GO) initiativeOpportunities” (GO) initiative

““Substantially accelerate comparative effectiveness Substantially accelerate comparative effectiveness research, advance methods development and priority research, advance methods development and priority setting, and forge robust infrastructure to support the setting, and forge robust infrastructure to support the conduct of comparative effectiveness research.”conduct of comparative effectiveness research.”

NHLBI Award 1RC2HL101512-01NHLBI Award 1RC2HL101512-01

$2.6M over 2 years$2.6M over 2 years

Funding SupportFunding SupportFunding SupportFunding Support

OrganizationOrganizationOrganizationOrganization

Principal InvestigatorRobert A. Harrington

Principal InvestigatorRobert A. Harrington

Project LeaderBritt Barham

Project LeaderBritt Barham

Advisory CommitteeChair: Eric Peterson

With Representatives From: ACC NIH/NHLBI CMS AHRQ FDA (CDER/CBER/CDRH) AHA FDA (Postmarket) SCAI

Advisory CommitteeChair: Eric Peterson

With Representatives From: ACC NIH/NHLBI CMS AHRQ FDA (CDER/CBER/CDRH) AHA FDA (Postmarket) SCAI

Operations GroupChair: David F. Kong

DCRI: E. Peterson ACC: J. Rumsfeld L. Melton K. Hewitt

With Representatives From: NCDR Scientific Committee CTNBP NCDR Informatics Committee

Operations GroupChair: David F. Kong

DCRI: E. Peterson ACC: J. Rumsfeld L. Melton K. Hewitt

With Representatives From: NCDR Scientific Committee CTNBP NCDR Informatics Committee

ACC Project Manager Laura Ritzenthaler

ACC Project Manager Laura Ritzenthaler

Educational Tools

Educational Tools

Data Management

Data Management

DCRI Information Technology

DCRI Information Technology

NCDR Site Management/

Contracts

NCDR Site Management/

Contracts

Guidelines CommitteesGuidelines

CommitteesNCDR

Information Technology

NCDR Information Technology

ImplementationImplementationData Reporting ProcessData Reporting Process

ImplementationImplementationData Reporting ProcessData Reporting Process

EducationEducationEducationEducation

Deliver educational content and tools via NCRI web Deliver educational content and tools via NCRI web portalportal

Screening and recruitment techniquesScreening and recruitment techniques Human subjects protectionHuman subjects protection GCPGCP Managing a clinical research practiceManaging a clinical research practice Protocol writingProtocol writing Site finances and budgetingSite finances and budgeting

Deliver educational content and tools via NCRI web Deliver educational content and tools via NCRI web portalportal

Screening and recruitment techniquesScreening and recruitment techniques Human subjects protectionHuman subjects protection GCPGCP Managing a clinical research practiceManaging a clinical research practice Protocol writingProtocol writing Site finances and budgetingSite finances and budgeting

Site DevelopmentSite DevelopmentSite DevelopmentSite Development

Develop NCDR participating sites as a clinical Develop NCDR participating sites as a clinical research networkresearch network

Master contractingMaster contracting Adapt workflows from registry to researchAdapt workflows from registry to research Selected data items collected at point-of-careSelected data items collected at point-of-care Foster relationships between quality and research Foster relationships between quality and research

personnel at the site levelpersonnel at the site levelPhysiciansPhysiciansResearch coordinatorsResearch coordinatorsQuality managersQuality managersDatabase administratorsDatabase administrators

Develop NCDR participating sites as a clinical Develop NCDR participating sites as a clinical research networkresearch network

Master contractingMaster contracting Adapt workflows from registry to researchAdapt workflows from registry to research Selected data items collected at point-of-careSelected data items collected at point-of-care Foster relationships between quality and research Foster relationships between quality and research

personnel at the site levelpersonnel at the site levelPhysiciansPhysiciansResearch coordinatorsResearch coordinatorsQuality managersQuality managersDatabase administratorsDatabase administrators

Contribute NCDR registry data elements to standards Contribute NCDR registry data elements to standards development process development process

Robust, vocabulary-based data element definitionsRobust, vocabulary-based data element definitions

Harmonize EHRs, quality reporting, and research systemsHarmonize EHRs, quality reporting, and research systems

Inform regulatory processes through FDA, AHRQInform regulatory processes through FDA, AHRQ

Representations in CDISC and HL7 RIM-based standardsRepresentations in CDISC and HL7 RIM-based standards

Submission for 2011 HL7 ballotSubmission for 2011 HL7 ballot

ACC Data Standards Task Force and Informatics ACC Data Standards Task Force and Informatics Committee to ensure collaboration across complimentary Committee to ensure collaboration across complimentary NCRI and ACC initiatives.NCRI and ACC initiatives.

Contribute NCDR registry data elements to standards Contribute NCDR registry data elements to standards development process development process

Robust, vocabulary-based data element definitionsRobust, vocabulary-based data element definitions

Harmonize EHRs, quality reporting, and research systemsHarmonize EHRs, quality reporting, and research systems

Inform regulatory processes through FDA, AHRQInform regulatory processes through FDA, AHRQ

Representations in CDISC and HL7 RIM-based standardsRepresentations in CDISC and HL7 RIM-based standards

Submission for 2011 HL7 ballotSubmission for 2011 HL7 ballot

ACC Data Standards Task Force and Informatics ACC Data Standards Task Force and Informatics Committee to ensure collaboration across complimentary Committee to ensure collaboration across complimentary NCRI and ACC initiatives.NCRI and ACC initiatives.

InteroperabilityInteroperability

Data standardsData standards

InteroperabilityInteroperability

Data standardsData standards

Proof-of-concept clinical trialProof-of-concept clinical trialProof-of-concept clinical trialProof-of-concept clinical trial

TransRAdial Education, Training, and Therapy TransRAdial Education, Training, and Therapy (TREATT)(TREATT)

Assess the impact of trans-radial and trans-femoral Assess the impact of trans-radial and trans-femoral device technique on safety of anticoagulant and device technique on safety of anticoagulant and antiplatelet medications.antiplatelet medications.

Part of the FDA Critical Path initiative and the Part of the FDA Critical Path initiative and the Cardiac Safety Research Consortium public-private Cardiac Safety Research Consortium public-private partnership (CSRC, www.cardiac-safety.org).partnership (CSRC, www.cardiac-safety.org).

Think tank June 23, 2010Think tank June 23, 2010

TransRAdial Education, Training, and Therapy TransRAdial Education, Training, and Therapy (TREATT)(TREATT)

Assess the impact of trans-radial and trans-femoral Assess the impact of trans-radial and trans-femoral device technique on safety of anticoagulant and device technique on safety of anticoagulant and antiplatelet medications.antiplatelet medications.

Part of the FDA Critical Path initiative and the Part of the FDA Critical Path initiative and the Cardiac Safety Research Consortium public-private Cardiac Safety Research Consortium public-private partnership (CSRC, www.cardiac-safety.org).partnership (CSRC, www.cardiac-safety.org).

Think tank June 23, 2010Think tank June 23, 2010