Enhancing Translational Research Enhancing Translational Research Through the Clinical and Translational Through the Clinical and Translational

Science AwardsScience Awards

AFMR 2007AFMR 2007

Barbara Alving, M.D.Director

NCRR, NIH

The Future Paradigm:The Future Paradigm: Transform Medicine from Curative to Preemptive

PreemptivePreemptivePersonalizedPersonalizedPredictivePredictive

ParticipatoryParticipatory

Rising U.S. Health ExpendituresRising U.S. Health ExpendituresBiomedical research must be part of the solutionBiomedical research must be part of the solution

8%

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20152012

20092006

20032000

19971994

19911988

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National Health Expenditures as a Percent of GDP

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Balanced National Biomedical Research Portfolio

NIH - $28B

Clinical Research

Basic Research

Translational Research

Private Sector - $59B

Clinical Research

Basic Research

Translational Research

New PathwaysNew Pathwaysto Discoveryto Discovery

Re-engineering theRe-engineering theClinical Research Clinical Research EnterpriseEnterprise

Research Teamsof the Future

The Three Themes of the NIH The Three Themes of the NIH Roadmap for Medical ResearchRoadmap for Medical Research

Clinical and Translational Science Awards Implementing 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 lower barriers 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 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 Goals

Develop 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

Trial DesignTrial Design

AdvancedAdvanced Degree-GrantingDegree-Granting

ProgramsPrograms

ParticipantParticipant& Community& CommunityInvolvementInvolvement

RegulatoryRegulatorySupportSupport

BiostatisticsBiostatistics

ClinicalClinicalResourcesResources

BiomedicalBiomedicalInformaticsInformatics

ClinicalClinicalResearchResearch

EthicsEthics

CTSACTSAHOMEHOME

NIH

OtherInstitutions

IndustryIndustry

NIH CTSA Award: A Home for Clinical and Translational Science

First CTSA Awards Announced October 3

12 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 science

NIH Funds Network for Medical Research

WEDNESDAY, OCTOBER 4, 2006

U.S. funds creation of national health research

network

NO. 1 IN THE USA . . . FIRST IN DAILY NEWS

NIH Funds a Dozen 'Homes' for Translational Research

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

Planning Grants (52)CTSA Awards (12)

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UTHSC, Houston

Mayo-Rochester

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Training and Career Development

Core curriculum could include: Biostatistics Bioethics Clinical trials design Informatics Health data standards Observational study design And more

Training and Career Development Key components of CTSA

Features: Graduate-granting and post graduate programs Diverse disciplines: pediatrics, surgery, dentistry,

pharmacology Includes study coordinators, project managers, key

personnel Integrated and flexible research education Predoctoral training Career development environment

Partnerships

Food and Drug Administration (FDA) Center for Medicare and Medicaid Services (CMS)

Data analysis, clinical trials Veterans Administration (VA)

Informatics, clinical trials Public-Private Partnerships

Developing better approaches for IP, cofunding large

initiatives through the Foundation for the NIH

Opportunities for Best PracticesOpportunities for Best PracticesCTSA ExamplesCTSA ExamplesRockefeller University Establish national research nursing standards Share research pharmacy best practices Collaborate with NIH Clinical Center to measure the experience of

clinical research participants

University of Pennsylvania Involve industry scientists in teaching and in training Bridge the pediatric/adult interface

University of California, Davis Partner with schools of veterinary medicine, biological sciences,

engineering, environmental sciences, and the state health care system in cross-disciplinary efforts

Provide clinical consultations through novel telecommunications

Examples of CTSA ActivitiesDuke University Translate 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 University Developing 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 Challenges The 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 Institutions

Mayo Clinic and University of Pennsylvania Involved 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 Clinic

Involved in caBIG vocabularies and common data elements

Beyond the CTSA Consortium: Opportunities for Interaction with Diverse Communities CTSAs 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 Institutions

18 Centers in 10 States, the District of Columbia, and Puerto Rico

IDeA-Eligible States

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= IDeA-Eligible States= IDeA-Eligible States

2323 statewide networks among statewide networks among universities and collegesuniversities and colleges

7373 thematic research centers thematic research centers

U. Hawaii

U. NevadaReno

U. Wyoming

U. of Idaho Montana State U.

U. Alaska

Connecting universities and researchers in the rural west to advanced national Connecting universities and researchers in the rural west to advanced national cyberinfrastructure for access to e-science opportunities and informatics resources. cyberinfrastructure for access to e-science opportunities and informatics resources.

LARIAT:LARIAT:

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The Future The 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 Working as a Consortium http://ctsaweb.org/http://ctsaweb.org/