A Vision for Clinical andA Vision for Clinical andTranslational ResearchTranslational Research

Presentation to thePresentation to theClinical Research SeminarClinical Research Seminar

The University of OklahomaThe University of OklahomaHealth Sciences CenterHealth Sciences Center

Barbara Alving, M.D.Barbara Alving, M.D.Acting DirectorActing Director

NCRR, NIHNCRR, NIH

Acute to chronic conditionsAcute to chronic conditions

Public Health ChallengesPublic Health Challenges

Health DisparitiesHealth Disparities

Emerging DiseasesEmerging Diseases

Aging PopulationAging Population

BiodefenseBiodefense

The Research EnterpriseThe Research Enterprise

Basic Research

Applied Research

Clinical Investigations

and Trials

Demonstration and Education

Research

Knowledge Acquisition

Knowledge Validation

Knowledge Transfer

Knowledge Dissemination

HealthHealthof the of the NationNation

Challenges to Interdisciplinary ResearchChallenges to Interdisciplinary Research

The current system of The current system of academic advancement academic advancement favors the independent favors the independent investigatorinvestigator

Most institutions house Most institutions house scientists in discrete scientists in discrete departmentsdepartments

Interdisciplinary research Interdisciplinary research teams take time to assemble teams take time to assemble and require unique resourcesand require unique resources

Why a Roadmap?Why a Roadmap?

Accelerated pace of discoveries in the Accelerated pace of discoveries in the life scienceslife sciences

Need for their more rapid translation Need for their more rapid translation into practiceinto practice

Opportunities to build an integrated Opportunities to build an integrated system that is far more effective than system that is far more effective than current approachescurrent approaches

New PathwaysNew Pathwaysto Discoveryto Discovery

Re-engineering theRe-engineering theClinical Research Clinical Research EnterpriseEnterprise

Research Teamsof the Future

The Three Themes of the NIHThe Three Themes of the NIHRoadmap for Medical ResearchRoadmap for Medical Research

BenchBench BedsideBedside PracticePractice

Building BlocksBuilding Blocks and Pathwaysand PathwaysMolecular Molecular LibrariesLibrariesBioinformaticsBioinformaticsComputationalComputational BiologyBiologyNanomedicineNanomedicine

TranslationalTranslationalResearchResearchInitiativesInitiatives

Integrated Research NetworksIntegrated Research NetworksClinical Research Informatics Clinical Research Informatics NIH Clinical Research AssociatesNIH Clinical Research AssociatesClinical OutcomesClinical Outcomes

Interdisciplinary Interdisciplinary ResearchResearchInnovator AwardInnovator Award Public-Private Public-Private

PartnershipsPartnerships

Cross-cutting: Harmonization, TrainingCross-cutting: Harmonization, Training

Re-engineering Clinical ResearchRe-engineering Clinical Research

Major Shifts in Priorities at AHCsMajor Shifts in Priorities at AHCs

Explosion in clinical service demands and reduction Explosion in clinical service demands and reduction in financial margins side-lines the training of clinician in financial margins side-lines the training of clinician scientistsscientists

Marked increase in numbers of faculty leads to a Marked increase in numbers of faculty leads to a “dilution” effect with a decreasing valuation attached “dilution” effect with a decreasing valuation attached to translational and clinical sciences to translational and clinical sciences

The complexity of knowledge needed to be an The complexity of knowledge needed to be an effective translational scientist is not easily acquired effective translational scientist is not easily acquired

Young clinical faculty have trouble finding a real Young clinical faculty have trouble finding a real “HOME” for their aspirations “HOME” for their aspirations

A Transforming Goal:A Transforming Goal:

Provide the academic home and integrated Provide the academic home and integrated resources needed to advance the new resources needed to advance the new intellectual discipline of clinical and intellectual discipline of clinical and translational sciences, create and nurture a translational sciences, create and nurture a cadre of well-trained investigators, and cadre of well-trained investigators, and advance the health of the nation by advance the health of the nation by transforming patient observations and basic transforming patient observations and basic discovery research into clinical practicediscovery research into clinical practice

Clinical and Translational Science Clinical and Translational Science Awards (CTSA)Awards (CTSA)

Implementing biomedical discoveries Implementing biomedical discoveries made in the last 10 years demands an made in the last 10 years demands an evolution of clinical scienceevolution of clinical science

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

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

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

Where are we starting from?Where are we starting from?

TrainingPrograms K30

Curriculum

GCRC

Disease X

Center

Disease Y

Center

Missing Pieces needed to form a Home Missing Pieces needed to form a Home for Clinical and Translational Sciencesfor Clinical and Translational Sciences

TrainingTrainingProgramsPrograms K30K30

CurriculumCurriculum

GCRCGCRC

DiseaseDisease XX

CenterCenter

DiseaseDisease YY

CenterCenter

ClinicalClinicalResearchResearch

DesignDesign IncubatorIncubator

NIH NIH RAIDRAID

TranslationalTranslationalcorescores

Upgraded Upgraded biostatisticsbiostatistics

Degree Degree grantinggranting

Upgraded Upgraded informaticsinformatics

IRBIRB Upgraded Upgraded regulatory regulatory

adviceadvice

NECTARNECTARNCRANCRA

NIH CTSA Awards: NIH CTSA Awards: A Home for Clinical and Translational A Home for Clinical and Translational

ScienceScience

Trial DesignTrial Design

AdvancedAdvanced Degree-GrantingDegree-Granting

ProgramsPrograms

ParticipantParticipant& Community& CommunityInvolvementInvolvement

RegulatoryRegulatorySupportSupport

BiostatisticsBiostatistics

ClinicalClinicalResourcesResources

BiomedicalBiomedicalInformaticsInformatics

ClinicalClinicalResearchResearch

EthicsEthics

CTSACTSAHOMEHOME

Industry

Industry

OtherOther

Institutio

ns

Institutio

ns

New Programs Will Support Different New Programs Will Support Different Experimental Models and ApproachesExperimental Models and Approaches

Flexible programs with adjustable sizes for different needsFlexible programs with adjustable sizes for different needs

Need

HaveHaveHaveHave

NeedNeed

NeedNeed

Research-Intensive AHC Small AHCResearch-Intensive AHC Small AHC

How is this transformation achieved?How is this transformation achieved?

Through the NIH Roadmap for Medical Research, Through the NIH Roadmap for Medical Research, create an integrated environment for the clinical and create an integrated environment for the clinical and translational researcher that can provide:translational researcher that can provide:

an academic home for clinical research (a Center, Department, an academic home for clinical research (a Center, Department, or Institute [C/D/I])or Institute [C/D/I])

support for protocol preparation, regulatory compliance, and support for protocol preparation, regulatory compliance, and data managementdata management

support for participant recruitment, human subject safety support for participant recruitment, human subject safety monitoringmonitoring

education leading to advanced degrees in clinical researcheducation leading to advanced degrees in clinical research

specialized cores and services for translational researchspecialized cores and services for translational research

DefinitionsDefinitions

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

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

CTSA EligibilityCTSA Eligibility

Domestic institutions, universities, academic Domestic institutions, universities, academic health centers, or other organizations health centers, or other organizations conducting clinical and translational research conducting clinical and translational research may apply.may apply.

Partnerships with independent and other Partnerships with independent and other research institutions are strongly encouraged.research institutions are strongly encouraged.

Institutions can only submit, or be part of, a Institutions can only submit, or be part of, a single application.single application.

CTSA EligibilityCTSA Eligibility

A graduate school accredited to award higher A graduate school accredited to award higher degrees in clinical research must be included.degrees in clinical research must be included.

The graduate school could be at an affiliate rather The graduate school could be at an affiliate rather than the applicant institution. Prior awarding of than the applicant institution. Prior awarding of higher degrees in clinical research (MS, PhD) is higher degrees in clinical research (MS, PhD) is expected.expected.

By requiring a degree-granting academic program, By requiring a degree-granting academic program, NIH expects to create en environment that will foster NIH expects to create en environment that will foster the development of clinical and translational science the development of clinical and translational science as a distinct disciplineas a distinct discipline

CTSA EligibilityCTSA Eligibility

The opportunities offered through a CTSA The opportunities offered through a CTSA should be wide ranging. Participation by should be wide ranging. Participation by multiple schools (e.g., nursing, pharmacy, multiple schools (e.g., nursing, pharmacy, dentistry, engineering—to name a few) and dentistry, engineering—to name a few) and partnerships with independent and other partnerships with independent and other research institutions are strongly encouraged.research institutions are strongly encouraged.

FY 2006 CTSA Funding OpportunitiesFY 2006 CTSA Funding Opportunities

RM-06-002:RM-06-002: Institutional Clinical and Translational Institutional Clinical and Translational Science Award RFAScience Award RFA

RM-06-001:RM-06-001: Planning Grant RFA for Institutional Planning Grant RFA for Institutional CTSAsCTSAs

an academic home for clinical research (a Center, an academic home for clinical research (a Center, Department, or Institute [C/D/I])Department, or Institute [C/D/I])

support for protocol preparation, regulatory compliance, support for protocol preparation, regulatory compliance, and data managementand data management

~50 awards, $150K direct costs; $11.5 M total~50 awards, $150K direct costs; $11.5 M total

CTSA FundingCTSA Funding

Up to $6 million in total costs per year in addition to Up to $6 million in total costs per year in addition to combined current total costs of certain NIH awardscombined current total costs of certain NIH awards NCRR: K12, K30, M01 (GCRC)NCRR: K12, K30, M01 (GCRC) Roadmap: T32 and K12Roadmap: T32 and K12

Approximately $30 M to support 4 –7 awards in FY Approximately $30 M to support 4 –7 awards in FY 2006, in addition to amounts from existing awards2006, in addition to amounts from existing awards

Length of awards: 5 yearsLength of awards: 5 years

Plan to expand to 60 awards, costing in aggregate Plan to expand to 60 awards, costing in aggregate up to $500 M, by 2012up to $500 M, by 2012

How to Construct a CTSA BudgetHow to Construct a CTSA Budget

T32K30K12

GCRC

Cores Cores Trainee SlotsTrainee SlotsCurriculumCurriculumPilot ProjectsPilot ProjectsGovernanceGovernance

Existing componentsExisting components

New CTSANew CTSA

Governance

Pilot Projects

Curriculum

T32 Slots

Cores, ClinicalTranslational

Design/Stat/Ethic

Community

Regulatory

Transition existing Transition existing resources into an resources into an integrated programintegrated program

RM

NIH

NCRRRM

NCRR

T32T32

K12K12

U54U54

K12 Slots

BudgetBudget

FY 2006 Timeline forFY 2006 Timeline forPlanning Grants and CTSAsPlanning Grants and CTSAs

October 12, 2005:October 12, 2005: Published RFAs (CTSAPublished RFAs (CTSA andand Planning Grant)Planning Grant)October 17, 2005:October 17, 2005: CTSA Pre-Submission MeetingCTSA Pre-Submission Meeting

December 7, 2005December 7, 2005 CTSA Technical Grant WritingCTSA Technical Grant Writing WorkshopWorkshop

February 27, 2006:February 27, 2006: Letters of Intent DueLetters of Intent Due

March 27, 2006:March 27, 2006: Applications DueApplications Due

Summer 2006:Summer 2006: Review ApplicationsReview Applications

September 2006:September 2006: Fund GrantsFund Grants

http://nihroadmap.nih.govhttp://nihroadmap.nih.gov

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