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National Cardiovascular Research Infrastructure (NCRI) Summary Slide Set

National Cardiovascular Research Infrastructure (NCRI) Summary Slide Set. May 5, 2010. Clinical Research in Crisis. Most clinical guideline recommendations founded only upon “expert consensus” Repetitive creation and disassembly of operational infrastructure for individual trials

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National Cardiovascular Research Infrastructure (NCRI) Summary Slide Set

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  1. National Cardiovascular Research Infrastructure (NCRI)Summary Slide Set May 5, 2010

  2. Clinical Research in Crisis • Most clinical guideline recommendations founded only upon “expert consensus” • Repetitive creation and disassembly of operational infrastructure for individual trials • Only 10% of sites enroll 40% of patients in large cardiovascular clinical trials. • 15% of sites obtaining IRB approvals never enroll anyone. • Fragmented data collection prevents true interoperability, costing $156 million annually in data transfers.

  3. NCRI Mission Integrate existing resources to efficiently execute large simple clinical research projects • 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

  4. NCRI Mission • Adding randomization to data acquisition harnesses the NCDR backbone to create an efficient platform for large simple randomized clinical trials. • Extend the NCDR mission from measuring healthcare quality to • providing key evidence to inform evolving evidence-based practice guidelines • enhancing patient safety through post market surveillance and pharmacovigilance

  5. Specific Aims • Aim 1: Expanding NCDR Site Capability • Aim 2: Facilitate standards and interoperability for cardiovascular clinical research founded on NCDR and CDISC. • Aim 3: A large simple randomized clinical trials platform to solicit and advance research questions that fill critical evidence gaps. • Aim 4: An integrated electronic repository of tools and programs to assist clinical research site activities accessible by a Web-based informatics infrastructure

  6. Funding Support • American Recovery & Reinvestment Act of 2009 (ARRA) • NIH Research and Research Infrastructure “Grand Opportunities” (GO) initiative • “Substantially accelerate comparative effectiveness research, advance methods development and priority setting, and forge robust infrastructure to support the conduct of comparative effectiveness research.” • NHLBI Award 1RC2HL101512-01 • $2.6M over 2 years

  7. Principal Investigator Robert A. Harrington Operations Group Chair: David F. Kong DCRI: E. Peterson ACC: J. Rumsfeld L. Melton K. Hewitt With Representatives From: NCDR Scientific Committee CTNBP NCDR Informatics Committee Advisory Committee Chair: Eric Peterson With Representatives From: ACC NIH/NHLBI CMS AHRQ FDA (CDER/CBER/CDRH) AHA FDA (Postmarket) SCAI ACC Project Manager Laura Ritzenthaler Project Leader Britt Barham NCDR Site Management/ Contracts Guidelines Committees NCDR Information Technology Educational Tools Data Management DCRI Information Technology Organization

  8. ImplementationData Reporting Process

  9. Education • 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

  10. Site Development • 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 • Physicians • Research coordinators • Quality managers • Database administrators

  11. InteroperabilityData standards • Contribute NCDR registry data elements to standards development process • Robust, vocabulary-based data element definitions • Harmonize EHRs, quality reporting, and research systems • Inform regulatory processes through FDA, AHRQ • Representations in CDISC and HL7 RIM-based standards • Submission for 2011 HL7 ballot • ACC Data Standards Task Force and Informatics Committee to ensure collaboration across complimentary NCRI and ACC initiatives.

  12. Proof-of-concept clinical trial • TransRAdial Education, Training, and Therapy (TREATT) • Assess the impact of trans-radial and trans-femoral device technique on safety of anticoagulant and antiplatelet medications. • Part of the FDA Critical Path initiative and the Cardiac Safety Research Consortium public-private partnership (CSRC, www.cardiac-safety.org). • Think tank June 23, 2010

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