Presentation on theme: "A Vision for Clinical and Translational Research Presentation to the Clinical Research Seminar The University of Oklahoma Health Sciences Center Barbara."— Presentation transcript:
1A Vision for Clinical and Translational Research Presentation to the Clinical Research Seminar The University of Oklahoma Health Sciences Center Barbara Alving, M.D. Acting Director NCRR, NIH
2Public Health Challenges Acute to chronic conditionsAging PopulationHealth DisparitiesEmerging DiseasesBiodefense
3The Research Enterprise Basic ResearchApplied ResearchClinical Investigations and TrialsDemonstration and Education ResearchKnowledge AcquisitionKnowledge ValidationKnowledge TransferKnowledge DisseminationHealth of the Nation
4Challenges to Interdisciplinary Research The current system of academic advancement favors the independent investigatorMost institutions house scientists in discrete departmentsInterdisciplinary research teams take time to assemble and require unique resourcesa single PI is recognized; indirect costs from collaborating institutions become embedded in direct costs of the “lead” institution indirect costs follow the PI.
5Why a Roadmap? Accelerated pace of discoveries in the life sciences Need for their more rapid translation into practiceOpportunities to build an integrated system that is far more effective than current approaches
6The Three Themes of the NIH Roadmap for Medical Research New Pathwaysto DiscoveryResearch Teamsof the FutureRe-engineering theClinical ResearchEnterprise
7Re-engineering Clinical Research InterdisciplinaryResearchInnovator AwardPublic-Private PartnershipsBenchBedsidePracticeBuilding Blocksand PathwaysMolecular LibrariesBioinformaticsComputationalBiologyNanomedicineIntegrated Research NetworksClinical Research InformaticsNIH Clinical Research AssociatesClinical OutcomesTranslationalResearchInitiativesCross-cutting: Harmonization, Training
8Major Shifts in Priorities at AHCs Explosion in clinical service demands and reduction in financial margins side-lines the training of clinician scientistsMarked increase in numbers of faculty leads to a “dilution” effect with a decreasing valuation attached to translational and clinical sciencesThe complexity of knowledge needed to be an effective translational scientist is not easily acquiredYoung clinical faculty have trouble finding a real “HOME” for their aspirations
9A Transforming Goal:Provide the academic home and integrated resources needed to advance the new intellectual discipline of clinical and translational sciences, create and nurture a cadre of well-trained investigators, and advance the health of the nation by transforming patient observations and basic discovery research into clinical practice
10Clinical and Translational Science Awards (CTSA) Implementing biomedical discoveries made in the last 10 years demands an evolution of clinical scienceNew prevention strategies and treatments must be developed, tested, and brought into medical practice more rapidlyCTSA awards will lower barriers between disciplines, and encourage creative, innovative approaches to solve complex medical problemsThese clinical and translational science awards will catalyze change -- breaking silos, breaking barriers, and breaking conventions
11Where are we starting from? TrainingProgramsK30CurriculumGCRCDiseaseXCenterY
12Missing Pieces needed to form a Home for Clinical and Translational Sciences UpgradedbiostatisticsUpgradedinformaticsDiseaseXCenterClinicalResearchDesignIncubatorIRBGCRCUpgradedregulatoryadviceNECTARNCRATranslationalcoresTrainingProgramsDiseaseYCenterNIHRAIDDegreegrantingK30Curriculum
13NIH CTSA Awards: A Home for Clinical and Translational Science IndustryClinicalResearchEthicsTrial DesignBiomedicalInformaticsAdvancedDegree-GrantingProgramsCTSAHOMEOtherInstitutionsParticipant& CommunityInvolvementClinicalResourcesBiostatisticsRegulatorySupport
14New Programs Will Support Different Experimental Models and Approaches Research-Intensive AHC Small AHCNeedHaveFlexible programs with adjustable sizes for different needs
15How is this transformation achieved? Through the NIH Roadmap for Medical Research, create an integrated environment for the clinical and translational researcher that can provide:an academic home for clinical research (a Center, Department, or Institute [C/D/I])support for protocol preparation, regulatory compliance, and data managementsupport for participant recruitment, human subject safety monitoringeducation leading to advanced degrees in clinical researchspecialized cores and services for translational research
16DefinitionsClinical 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.Needed to support tasks at large institutionsINCLUDES ACADEMIC COMPONENT AND SERVICE
17CTSA EligibilityDomestic institutions, universities, academic health centers, or other organizations conducting clinical and translational research may apply.Partnerships with independent and other research institutions are strongly encouraged.Institutions can only submit, or be part of, a single application.
18CTSA EligibilityA graduate school accredited to award higher degrees in clinical research must be included.The graduate school could be at an affiliate rather than the applicant institution. Prior awarding of higher degrees in clinical research (MS, PhD) is expected.By requiring a degree-granting academic program, NIH expects to create en environment that will foster the development of clinical and translational science as a distinct discipline
19CTSA EligibilityThe opportunities offered through a CTSA should be wide ranging. Participation by multiple schools (e.g., nursing, pharmacy, dentistry, engineering—to name a few) and partnerships with independent and other research institutions are strongly encouraged.
20FY 2006 CTSA Funding Opportunities RM : Institutional Clinical and Translational Science Award RFARM : Planning Grant RFA for Institutional CTSAsan academic home for clinical research (a Center, Department, or Institute [C/D/I])support for protocol preparation, regulatory compliance, and data management~50 awards, $150K direct costs; $11.5 M total? Increase later on to average size of other program…
21CTSA FundingUp to $6 million in total costs per year in addition to combined current total costs of certain NIH awardsNCRR: K12, K30, M01 (GCRC)Roadmap: T32 and K12Approximately $30 M to support 4 –7 awards in FY 2006, in addition to amounts from existing awardsLength of awards: 5 yearsPlan to expand to 60 awards, costing in aggregate up to $500 M, by 2012
22How to Construct a CTSA Budget New CTSABudgetT32 SlotsT32K12U54Existing componentsK12 SlotsCurriculumCoresTrainee SlotsCurriculumPilot ProjectsGovernanceDesign/Stat/EthicRMNIHNCRRT32K30K12GCRCCommunityCores, ClinicalTranslationalTwo implementation issuesHow to constructSizeWhere is money coming fromTransition existing resources into an integrated programPilot ProjectsRegulatoryGovernance
23FY 2006 Timeline for Planning Grants and CTSAs October 12, 2005: Published RFAs (CTSAand Planning Grant)October 17, 2005: CTSA Pre-Submission MeetingDecember 7, CTSA Technical Grant WritingWorkshopFebruary 27, 2006: Letters of Intent DueMarch 27, 2006: Applications DueSummer 2006: Review ApplicationsSeptember 2006: Fund Grants