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A Vision for Clinical andA Vision for Clinical and
Translational ResearchTranslational Research
Presentation to thePresent...
Acute to chronic conditionsAcute to chronic conditions
Public Health ChallengesPublic Health Challenges
Health Disparities...
The Research EnterpriseThe Research Enterprise
Basic
Research
Applied
Research
Clinical
Investigations
and Trials
Demonstr...
Challenges to Interdisciplinary ResearchChallenges to Interdisciplinary Research
 The current system ofThe current system...
Why a Roadmap?Why a Roadmap?
 Accelerated pace of discoveries in theAccelerated pace of discoveries in the
life sciencesl...
New PathwaysNew Pathways
to Discoveryto Discovery
Re-engineering theRe-engineering the
Clinical ResearchClinical Research
...
BenchBench BedsidBedsid
ee
PracticePractice
Building BlocksBuilding Blocks
and Pathwaysand Pathways
MolecularMolecular
Lib...
Major Shifts in Priorities at AHCsMajor Shifts in Priorities at AHCs
 Explosion in clinical service demands and reduction...
A Transforming Goal:A Transforming Goal:
Provide the academic home and integratedProvide the academic home and integrated
...
Clinical and Translational ScienceClinical and Translational Science
Awards (CTSA)Awards (CTSA)
 Implementing biomedical ...
Where are we starting from?Where are we starting from?
Training
Programs K30
Curriculum
GCRC
Disease
X
Center
Disease
Y
Ce...
Missing Pieces needed to form a HomeMissing Pieces needed to form a Home
for Clinical and Translational Sciencesfor Clinic...
NIH CTSA Awards:NIH CTSA Awards:
A Home for Clinical and TranslationalA Home for Clinical and Translational
ScienceScience...
New Programs Will Support DifferentNew Programs Will Support Different
Experimental Models and ApproachesExperimental Mode...
How is this transformation achieved?How is this transformation achieved?
 Through the NIH Roadmap for Medical Research,Th...
DefinitionsDefinitions
 Clinical ResearchClinical Research covers all studies ofcovers all studies of
diseases and trials...
CTSA EligibilityCTSA Eligibility
 Domestic institutions, universities, academicDomestic institutions, universities, acade...
CTSA EligibilityCTSA Eligibility
 A graduate school accredited to award higherA graduate school accredited to award highe...
CTSA EligibilityCTSA Eligibility
The opportunities offered through a CTSAThe opportunities offered through a CTSA
should b...
FY 2006 CTSA Funding OpportunitiesFY 2006 CTSA Funding Opportunities
 RM-06-002:RM-06-002: Institutional Clinical and Tra...
CTSA FundingCTSA Funding
 Up to $6 million in total costs per year in addition toUp to $6 million in total costs per year...
How to Construct a CTSA BudgetHow to Construct a CTSA Budget
T32
K30
K12
GCRC
CoresCores
Trainee SlotsTrainee Slots
Curric...
FY 2006 Timeline forFY 2006 Timeline for
Planning Grants and CTSAsPlanning Grants and CTSAs
October 12, 2005:October 12, 2...
http://nihroadmap.nih.govhttp://nihroadmap.nih.gov
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Major Trends in Biomedical Research

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Major Trends in Biomedical Research

  1. 1. A Vision for Clinical andA Vision for Clinical and Translational ResearchTranslational Research Presentation to thePresentation to the Clinical Research SeminarClinical Research Seminar The University of OklahomaThe University of Oklahoma Health Sciences CenterHealth Sciences Center Barbara Alving, M.D.Barbara Alving, M.D. Acting DirectorActing Director NCRR, NIHNCRR, NIH
  2. 2. Acute to chronic conditionsAcute to chronic conditions Public Health ChallengesPublic Health Challenges Health DisparitiesHealth Disparities Emerging DiseasesEmerging Diseases Aging PopulationAging Population BiodefenseBiodefense
  3. 3. 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 HealthHealth of theof the NationNation
  4. 4. Challenges to Interdisciplinary ResearchChallenges to Interdisciplinary Research  The current system ofThe current system of academic advancementacademic advancement favors the independentfavors the independent investigatorinvestigator  Most institutions houseMost institutions house scientists in discretescientists in discrete departmentsdepartments  Interdisciplinary researchInterdisciplinary research teams take time toteams take time to assemble and requireassemble and require unique resourcesunique resources
  5. 5. Why a Roadmap?Why a Roadmap?  Accelerated pace of discoveries in theAccelerated pace of discoveries in the life scienceslife sciences  Need for their more rapid translationNeed for their more rapid translation into practiceinto practice  Opportunities to build an integratedOpportunities to build an integrated system that is far more effective thansystem that is far more effective than current approachescurrent approaches
  6. 6. New PathwaysNew Pathways to Discoveryto Discovery Re-engineering theRe-engineering the Clinical ResearchClinical Research EnterpriseEnterprise Research Teams of the Future The Three Themes of the NIHThe Three Themes of the NIH Roadmap for Medical ResearchRoadmap for Medical Research
  7. 7. BenchBench BedsidBedsid ee PracticePractice Building BlocksBuilding Blocks and Pathwaysand Pathways MolecularMolecular LibrariesLibraries BioinformaticsBioinformatics ComputationalComputational BiologyBiology NanomedicineNanomedicine TranslationalTranslational ResearchResearch InitiativesInitiatives Integrated Research NetworksIntegrated Research Networks Clinical Research InformaticsClinical Research Informatics NIH Clinical Research AssociatesNIH Clinical Research Associates Clinical OutcomesClinical Outcomes InterdisciplinaryInterdisciplinary ResearchResearch Innovator AwardInnovator Award Public-PrivatePublic-Private PartnershipsPartnerships Cross-cutting: Harmonization, TrainingCross-cutting: Harmonization, Training Re-engineering Clinical ResearchRe-engineering Clinical Research
  8. 8. Major Shifts in Priorities at AHCsMajor Shifts in Priorities at AHCs  Explosion in clinical service demands and reductionExplosion in clinical service demands and reduction in financial margins side-lines the training ofin financial margins side-lines the training of clinician scientistsclinician scientists  Marked increase in numbers of faculty leads to aMarked increase in numbers of faculty leads to a “dilution” effect with a decreasing valuation“dilution” effect with a decreasing valuation attached to translational and clinical sciencesattached to translational and clinical sciences  The complexity of knowledge needed to be anThe complexity of knowledge needed to be an effective translational scientist is not easily acquiredeffective translational scientist is not easily acquired  Young clinical faculty have trouble finding a realYoung clinical faculty have trouble finding a real “HOME” for their aspirations“HOME” for their aspirations
  9. 9. A Transforming Goal:A Transforming Goal: Provide the academic home and integratedProvide the academic home and integrated resources needed to advance the newresources needed to advance the new intellectual discipline of clinical andintellectual discipline of clinical and translational sciences, create and nurture atranslational sciences, create and nurture a cadre of well-trained investigators, andcadre of well-trained investigators, and advance the health of the nation byadvance the health of the nation by transforming patient observations and basictransforming patient observations and basic discovery research into clinical practicediscovery research into clinical practice
  10. 10. Clinical and Translational ScienceClinical and Translational Science Awards (CTSA)Awards (CTSA)  Implementing biomedical discoveriesImplementing biomedical discoveries made in the last 10 years demands anmade in the last 10 years demands an evolution of clinical scienceevolution of clinical science  New prevention strategies andNew prevention strategies and treatments must be developed, tested,treatments must be developed, tested, and brought into medical practiceand brought into medical practice more rapidlymore rapidly  CTSA awards will lower barriersCTSA awards will lower barriers between disciplines, and encouragebetween disciplines, and encourage creative, innovative approaches tocreative, innovative approaches to solve complex medical problemssolve complex medical problems  These clinical and translationalThese clinical and translational science awards will catalyze change --science awards will catalyze change -- breaking silos, breaking barriers, andbreaking silos, breaking barriers, and breaking conventionsbreaking conventions
  11. 11. Where are we starting from?Where are we starting from? Training Programs K30 Curriculum GCRC Disease X Center Disease Y Center
  12. 12. Missing Pieces needed to form a HomeMissing Pieces needed to form a Home for Clinical and Translational Sciencesfor Clinical and Translational Sciences TrainingTraining ProgramsPrograms K30K30 CurriculumCurriculum GCRCGCRC DiseaseDisease XX CenterCenter DiseaseDisease YY CenterCenter ClinicalClinical ResearchResearch DesignDesign IncubatorIncubator NIHNIH RAIDRAID TranslationalTranslational corescores UpgradedUpgraded biostatisticsbiostatistics DegreeDegree grantinggranting UpgradedUpgraded informaticsinformatics IRBIRB UpgradedUpgraded regulatoryregulatory adviceadvice NECTARNECTAR NCRANCRA
  13. 13. NIH CTSA Awards:NIH CTSA Awards: A Home for Clinical and TranslationalA Home for Clinical and Translational ScienceScience Trial DesignTrial Design AdvancedAdvanced Degree-GrantingDegree-Granting ProgramsPrograms ParticipantParticipant & Community& Community InvolvementInvolvement RegulatoryRegulatory SupportSupport BiostatisticsBiostatistics ClinicalClinical ResourcesResources BiomedicalBiomedical InformaticsInformatics ClinicalClinical ResearchResearch EthicsEthics CTSACTSA HOMEHOME Industry Industry OtherOther Institutions Institutions
  14. 14. New Programs Will Support DifferentNew 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 HaveHave HaveHave NeedNeed NeedNeed Research-Intensive AHC Small AHCResearch-Intensive AHC Small AHC
  15. 15. 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 andcreate 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,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  support for participant recruitment, human subject safetysupport 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
  16. 16. DefinitionsDefinitions  Clinical ResearchClinical Research covers all studies ofcovers all studies of diseases and trials of treatments that takediseases and trials of treatments that take place in human subjects.place in human subjects.  Translational ResearchTranslational Research describes the stepsdescribes the steps between a fundamental discovery and itsbetween a fundamental discovery and its application in clinical medicine.application in clinical medicine.
  17. 17. CTSA EligibilityCTSA Eligibility  Domestic institutions, universities, academicDomestic institutions, universities, academic health centers, or other organizationshealth centers, or other organizations conducting clinical and translational researchconducting clinical and translational research may apply.may apply.  Partnerships with independent and otherPartnerships with independent and other research institutions are strongly encouraged.research institutions are strongly encouraged.  Institutions can only submit, or be part of, aInstitutions can only submit, or be part of, a single application.single application.
  18. 18. CTSA EligibilityCTSA Eligibility  A graduate school accredited to award higherA 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 ratherThe graduate school could be at an affiliate rather than the applicant institution. Prior awarding ofthan the applicant institution. Prior awarding of higher degrees in clinical research (MS, PhD) ishigher 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 fosterNIH expects to create en environment that will foster the development of clinical and translational sciencethe development of clinical and translational science as a distinct disciplineas a distinct discipline
  19. 19. CTSA EligibilityCTSA Eligibility The opportunities offered through a CTSAThe opportunities offered through a CTSA should be wide ranging. Participation byshould be wide ranging. Participation by multiple schools (e.g., nursing, pharmacy,multiple schools (e.g., nursing, pharmacy, dentistry, engineering—to name a few) anddentistry, engineering—to name a few) and partnerships with independent and otherpartnerships with independent and other research institutions are strongly encouraged.research institutions are strongly encouraged.
  20. 20. FY 2006 CTSA Funding OpportunitiesFY 2006 CTSA Funding Opportunities  RM-06-002:RM-06-002: Institutional Clinical and TranslationalInstitutional Clinical and Translational Science Award RFAScience Award RFA  RM-06-001:RM-06-001: Planning Grant RFA for InstitutionalPlanning 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
  21. 21. CTSA FundingCTSA Funding  Up to $6 million in total costs per year in addition toUp 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 FYApproximately $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 aggregatePlan to expand to 60 awards, costing in aggregate up to $500 M, by 2012up to $500 M, by 2012
  22. 22. How to Construct a CTSA BudgetHow to Construct a CTSA Budget T32 K30 K12 GCRC CoresCores Trainee SlotsTrainee Slots CurriculumCurriculum Pilot ProjectsPilot Projects GovernanceGovernance Existing componentsExisting components New CTSANew CTSA Governance Pilot Projects Curriculum T32 Slots Cores, Clinical Translational Design/Stat/Ethic Community Regulatory Transition existingTransition existing resources into anresources into an integrated programintegrated program RM NIH NCRR RM NCRR T32T32 K12K12 U54U54 K12 Slots BudgetBudget
  23. 23. FY 2006 Timeline forFY 2006 Timeline for Planning 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
  24. 24. http://nihroadmap.nih.govhttp://nihroadmap.nih.gov More InformationMore Information

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