enhancing translational research through the clinical and translational science awards afmr 2007

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Enhancing Translational Research Through the Clinical and Translational Science Awards AFMR 2007. Barbara Alving, M.D. Director NCRR, NIH. Participatory. The Future Paradigm: Transform Medicine from Curative to Preemptive. Predictive. Preemptive. Personalized. - PowerPoint PPT Presentation

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  • Enhancing Translational Research Through the Clinical and Translational Science Awards AFMR 2007Barbara Alving, M.D.Director NCRR, NIH

  • The Future Paradigm: Transform Medicine from Curative to PreemptivePreemptivePersonalizedPredictive

  • Rising U.S. Health ExpendituresBiomedical research must be part of the solution8%10%12%14%16%18%20%201520122009200620032000199719941991198819851982National Health Expenditures as a Percent of GDP1980ActualProjectedPercent of U.S. GDP

  • Balanced National Biomedical Research Portfolio

  • New Pathwaysto DiscoveryRe-engineering theClinical Research EnterpriseResearch Teamsof the FutureThe Three Themes of the NIH Roadmap for Medical Research

  • Clinical and Translational Science AwardsImplementing biomedical discoveries made in the last 10 years demands an evolution of clinical science

    New prevention strategies and treatments must be developed, tested, and brought into medical practice more rapidly

    CTSA awards will lowerbarriers between disciplines,and encourage creative, innovative approaches to solve complex medical problems

    These clinical and translational science awards will catalyze change -- breaking silos, breaking barriers, and breaking conventions

  • Definitions Clinical Research covers all studies of diseases and trials of treatments that take place in human subjects.

    Translational Research describes the steps between a fundamental discovery and its application in clinical medicine.

  • CTSA GoalsDevelop novel designs for clinical trials

    Educate the next generation

    Build diversity in leadership

    Assemble interdisciplinary teams

    Enhance public trust

    Forge new partnerships with private and public health care organizations

    Create a national consortium

  • NIH CTSA Award: A Home for Clinical and Translational ScienceTrial DesignAdvanced Degree-GrantingProgramsParticipant& CommunityInvolvement

    RegulatorySupportBiostatisticsClinicalResourcesBiomedicalInformaticsClinicalResearchEthicsCTSAHOMENIHOtherInstitutionsIndustry

  • First CTSA Awards Announced October 312 Academic Health Centers nationwide

    52 planning grants to prepare applications to join consortium

    In 2012, approximately 60 institutions will be linked to energize clinical and translational scienceNIH Funds a Dozen 'Homes' for Translational Research

  • Building A National CTSA Consortium FY 2006 CTSA Awards & Planning Grants

  • Training and Career DevelopmentCore curriculum could include:BiostatisticsBioethics Clinical trials designInformatics Health data standardsObservational study designAnd more

  • Training and Career Development Key components of CTSAFeatures:Graduate-granting and post graduate programsDiverse disciplines: pediatrics, surgery, dentistry, pharmacologyIncludes study coordinators, project managers, key personnelIntegrated and flexible research educationPredoctoral trainingCareer development environment

  • PartnershipsFood and Drug Administration (FDA)Center for Medicare and Medicaid Services (CMS) Data analysis, clinical trialsVeterans Administration (VA)Informatics, clinical trialsPublic-Private PartnershipsDeveloping better approaches for IP, cofunding large initiatives through the Foundation for the NIH

  • Opportunities for Best PracticesCTSA ExamplesRockefeller University Establish national research nursing standardsShare research pharmacy best practicesCollaborate with NIH Clinical Center to measure the experience of clinical research participants

    University of PennsylvaniaInvolve industry scientists in teaching and in trainingBridge the pediatric/adult interface

    University of California, DavisPartner with schools of veterinary medicine, biological sciences, engineering, environmental sciences, and the state health care system in cross-disciplinary effortsProvide clinical consultations through novel telecommunications

  • Examples of CTSA ActivitiesDuke UniversityTranslate bench-bedside findings to populations using advanced informatics and health services delivery methods

    University of California, San Francisco Pursue new opportunities with the San Francisco VA and Kaiser Permanente Create new community research centers to expand efforts in minority and medically underserved populations

    Oregon Health and Science UniversityDeveloping informatics capabilities to partner with Kaiser Permanente NW Center for Health Research, Oregon Rural Practice Research Network, Portland VA Medical Center for intervention research

  • Informatics ChallengesThe challenges to the informatics community are to:

    Adopt standards that can structure data, syntactically and semantically, from devices into the EHR and then into the longitudinal record

    Harmonize clinical informatics standards with research standards

    Work with research community to provide interactive clinical and research records.

  • Examples of Cancer Bioinformatics Grid (caBIG) Activities at CTSA InstitutionsMayo Clinic and University of PennsylvaniaInvolved in caBIG architecture, data sharing and intellectual capital, strategic planning, tissue banks and pathology tools, and training

    University of Pennsylvania Involved in caBIG imaging initiative and clinical trial management systems Mayo ClinicInvolved in caBIG vocabularies and common data elements

  • Beyond the CTSA Consortium: Opportunities for Interaction with Diverse CommunitiesCTSAs can develop partnerships with grantees at Research Centers in Minority Institutions (RCMIs) and in Institutional Development Award (IDeA) states

    Developing states and institutions offer geographically and ethnically diverse representation

    IDeA and RCMI grantees have track record in training and mentoring

  • Research Centers in Minority Institutions18 Centers in 10 States, the District of Columbia, and Puerto Rico

  • IDeA-Eligible StatesMTWYIDWAORNVUTCAAZNDSDNECONMTXOKKSARLAMOIAMNWIILINKYTNMSALGAFLSCNCVAWVOHMINYPAMEVTAKHIPRMDDENJCTRIMANHDC12= IDeA-Eligible States23 statewide networks among universities and colleges

    73 thematic research centers

  • LARIAT:U. HawaiiU. NevadaRenoU. WyomingU. of IdahoMontana State U.U. AlaskaConnecting universities and researchers in the rural west to advanced national cyberinfrastructure for access to e-science opportunities and informatics resources. MTWYIDORNVUTWACANDNEAZSDCONMTXOKKSARLAMOIAMNWIILINKYTNMSALGAFLSCNCVAWVOHMINYPAMEAKVTHIPRMDDENJCTRIMANHDC12

  • The FutureThe CTSA consortium offers an unparalleled opportunity to disseminate standards and best practices that will guide both translational and clinical research and health care delivery

    The success of the CTSA consortium will be measured in part by the acceptance of its standards

    CTSAs will partner with geographically and ethnically diverse institutions that broaden their impact

    The ultimate goal: continuous improvement in the health of populations and individuals throughout the nation

  • Working as a Consortium http://ctsaweb.org/

    Needed to support tasks at large institutionsINCLUDES ACADEMIC COMPONENT AND SERVICEOn October 3rd, I announced the names of the 12 academic health centers that would receive the first CTSAs. In addition, 52 academic health centers received planning grants to help them prepare applications to join the consortium.The twelve grants we made are substantially more than the seven or so that were originally envisionedWe were very impressed with the responsethe number of applicationsand the quality of the responseMany of the applications did so well during the peer review process that we felt it was appropriate to fund more of these institutions, since they clearly demonstrated an understanding of the CTSA vision and specific plans to achieve its goalsWhen fully implemented in 2012, about 60 institutions will be linked together to energize the discipline of clinical and translational research I want to make it clear that we are taking great care at NIH to preserve the investigator-initiated research support pool in these times of constrained budgets. Since the funding for the CTSAs is being derived from existing clinical research programs and the NIH Roadmap, no funds are being transferred away from basic research23 States and Puerto Rico are IDeA eligible. IDeA Eligible States have added challenges in developing a competitive research infrastructure. Many of the IDeA eligible states have only 1, or no medical school at all. And for Alaska (AK), Hawaii (HI), and Puerto Rico (PR), they have the added challenge of being physically separated from the rest of the continental US. The IDeA and RCMI programs are working to reduce the burdens of these challenges. Through the IDeA program, 23 INBRE statewide networks and 73 thematic COBRE research centers that are funded. One way that NCRR is doing this is through IDeANET, a part of the IDeA Program.

    IDeANet is an Internet-based network providing connectivity for high-bandwidth science applications. IDeANet will enable collaboration among institutions, ultimately supporting all participants in the IDeA Program, and also participants in the Research Centers in Minority Institutions (RCMI) Program. IDeANet will also provide connectivity to other NCRR-supported networks, such as the Biomedical Informatics Research Network (BIRN). IDeANet currently supports a test-bed consortium called Lariat, (http://www.lariat-west.org/) which consists of six IDeA states: Montana, Idaho, Nevada, Alaska, Hawaii, and Wyoming. The project supports staff in bioinformatics and data management cores, computer hardware and software, and Internet2 broad-bandwidth access.

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