Transcript NCRI Project Summary

National Cardiovascular
Research Infrastructure (NCRI)
Summary Slide Set
May 5, 2010
Clinical Research in Crisis
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Most clinical guideline recommendations founded only
upon “expert consensus”
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Repetitive creation and disassembly of operational
infrastructure for individual trials
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Only 10% of sites enroll 40% of patients in large
cardiovascular clinical trials.
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15% of sites obtaining IRB approvals never enroll anyone.
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Fragmented data collection prevents true interoperability,
costing $156 million annually in data transfers.
NCRI Mission
Integrate existing resources to efficiently execute large
simple clinical research projects
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Site recruitment and education (CTNBP)
Randomization (DCRI)
Data collection (NCDR)
Data standards (CDISC, HL7)
Guideline development (ACC)
The Infrastructure and operations requirements go far
beyond software and database programming
NCRI Mission
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Adding randomization to data acquisition harnesses
the NCDR backbone to create an efficient platform
for large simple randomized clinical trials.
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Extend the NCDR mission from measuring
healthcare quality to
 providing key evidence to inform evolving evidencebased practice guidelines
 enhancing patient safety through post market
surveillance and pharmacovigilance
Specific Aims
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Aim 1: Expanding NCDR Site Capability
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Aim 2: Facilitate standards and interoperability for
cardiovascular clinical research founded on NCDR
and CDISC.
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Aim 3: A large simple randomized clinical trials
platform to solicit and advance research questions
that fill critical evidence gaps.
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Aim 4: An integrated electronic repository of tools
and programs to assist clinical research site
activities accessible by a Web-based informatics
infrastructure
Funding Support
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American Recovery & Reinvestment Act of 2009
(ARRA)
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NIH Research and Research Infrastructure “Grand
Opportunities” (GO) initiative
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“Substantially accelerate comparative effectiveness
research, advance methods development and priority
setting, and forge robust infrastructure to support the
conduct of comparative effectiveness research.”
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NHLBI Award 1RC2HL101512-01
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$2.6M over 2 years
Organization
Principal Investigator
Robert A. Harrington
Operations Group
Chair: David F. Kong
DCRI: E. Peterson
L. Melton
ACC: J. Rumsfeld
K. Hewitt
With Representatives From:
NCDR Scientific Committee
NCDR Informatics Committee
CTNBP
Advisory Committee
Chair: Eric Peterson
With Representatives From:
ACC
CMS
FDA (CDER/CBER/CDRH)
FDA (Postmarket)
ACC Project Manager
Laura Ritzenthaler
NCDR Site
Management/
Contracts
Guidelines
Committees
NCDR
Information
Technology
NIH/NHLBI
AHRQ
AHA
SCAI
Project Leader
Britt Barham
Educational
Tools
Data
Management
DCRI
Information
Technology
Implementation
Data Reporting Process
Education
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Deliver educational content and tools via NCRI web
portal
 Screening and recruitment techniques
 Human subjects protection
 GCP
 Managing a clinical research practice
 Protocol writing
 Site finances and budgeting
Site Development
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Develop NCDR participating sites as a clinical
research network
 Master contracting
 Adapt workflows from registry to research
 Selected data items collected at point-of-care
 Foster relationships between quality and research
personnel at the site level
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Physicians
Research coordinators
Quality managers
Database administrators
Interoperability
Data standards
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Contribute NCDR registry data elements to standards
development process
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Robust, vocabulary-based data element definitions
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Harmonize EHRs, quality reporting, and research systems
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Inform regulatory processes through FDA, AHRQ
Representations in CDISC and HL7 RIM-based standards
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Submission for 2011 HL7 ballot
ACC Data Standards Task Force and Informatics
Committee to ensure collaboration across complimentary
NCRI and ACC initiatives.
Proof-of-concept clinical trial
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TransRAdial Education, Training, and Therapy
(TREATT)
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Assess the impact of trans-radial and trans-femoral
device technique on safety of anticoagulant and
antiplatelet medications.
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Part of the FDA Critical Path initiative and the
Cardiac Safety Research Consortium public-private
partnership (CSRC, www.cardiac-safety.org).
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Think tank June 23, 2010