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

2. Clinical Research in Crisis n Most clinical guideline recommendations founded only upon “expert consensus” n Repetitive creation and disassembly of operational infrastructure for individual trials n Only 10% of sites enroll 40% of patients in large cardiovascular clinical trials. n 15% of sites obtaining IRB approvals never enroll anyone. n Fragmented data collection prevents true interoperability, costing $156 million annually in data transfers. n Most clinical guideline recommendations founded only upon “expert consensus” n Repetitive creation and disassembly of operational infrastructure for individual trials n Only 10% of sites enroll 40% of patients in large cardiovascular clinical trials. n 15% of sites obtaining IRB approvals never enroll anyone. n 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 n Site recruitment and education (CTNBP) n Randomization (DCRI) n Data collection (NCDR) n Data standards (CDISC, HL7) n Guideline development (ACC) The Infrastructure and operations requirements go far beyond software and database programming Integrate existing resources to efficiently execute large simple clinical research projects n Site recruitment and education (CTNBP) n Randomization (DCRI) n Data collection (NCDR) n Data standards (CDISC, HL7) n Guideline development (ACC) The Infrastructure and operations requirements go far beyond software and database programming

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

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

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

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

8. Implementation Data Reporting Process

9. EducationEducation n Deliver educational content and tools via NCRI web portal l Screening and recruitment techniques l Human subjects protection l GCP l Managing a clinical research practice l Protocol writing l Site finances and budgeting n Deliver educational content and tools via NCRI web portal l Screening and recruitment techniques l Human subjects protection l GCP l Managing a clinical research practice l Protocol writing l Site finances and budgeting

10. Site Development n Develop NCDR participating sites as a clinical research network l Master contracting l Adapt workflows from registry to research l Selected data items collected at point-of-care l Foster relationships between quality and research personnel at the site level l Physicians l Research coordinators l Quality managers l Database administrators n Develop NCDR participating sites as a clinical research network l Master contracting l Adapt workflows from registry to research l Selected data items collected at point-of-care l Foster relationships between quality and research personnel at the site level l Physicians l Research coordinators l Quality managers l Database administrators

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

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