1 / 22

Center for Translational Science Activities (CTSA)

Center for Translational Science Activities (CTSA). David Warner, M.D. Associate Director and Co-PI, Mayo Clinic CTSA. Clinical and Translational Science Award Background. Existing clinical research infrastructure support grants predated the CTSA Education (K12, K30) GCRC

darlene
Télécharger la présentation

Center for Translational Science Activities (CTSA)

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Center for Translational Science Activities(CTSA) David Warner, M.D. Associate Director and Co-PI, Mayo Clinic CTSA ©2011 MFMER | 3117437-1

  2. Clinical and Translational Science AwardBackground Existing clinical research infrastructure support grants predated the CTSA Education (K12, K30) GCRC Desire by NIH to strengthen translational research; emphases on Moving discoveries into the “real world” Creating an “academic home” ©2011 MFMER | 3117437-2

  3. The Translational Research Continuum What works under controlled conditions? (Up to phase III trials) “Bench” “Bedside” Basic Biomedical Discovery Clinical Efficacy T1 CTSA supports all phases of translation What works in real world settings? (e.g., Comparative Effectiveness Research) T2 What is the effect on population health? (Outcomes research) T4 Clinical Effectiveness T3 Clinical Practice Community Practices How can we change practice? (Dissemination and Implementation Research) Community Practices

  4. Clinical and Translational Science AwardNational Institutes of Health Develop and train the next generation of inter-disciplinary investigators and research teams Create and use the latest methods and technologies for medical research Improve medical care by applying new scientific advances to real world practice Develop community-based networks to reach all members of our community ©2011 MFMER | 3117437-4

  5. The Mayo Clinic CTSA One of first 12 NIH awardees - October 2006 Scored well on renewal, and anticipate NOGA this summer Mandate to enhance, align and integrate clinical and translational science at Mayo Clinic ‘Academic home’ for clinical and translational science http://ctsa.mayo.edu ©2011 MFMER | 3117437-5

  6. Becoming a Translational ResearcherEducational Options • Certificate and Masters in Clinical Research • KL2 Mentored Career Development • Ph.D. in Clinical and Translational Science • Continuing Education (CME-eligible) http://ctsa.mayo.edu/education ©2011 MFMER | 3117437-6

  7. Funding Opportunities • High Impact Pilot and Feasibility Awards (HIPFA) • Scholarly Opportunity Award (SOA) • Novel Methodology Development Award • Technology Access Fund • KL2 Mentored Career Development Award

  8. Lifecycle of a Research Protocol ©2011 MFMER | 3117437-8

  9. Study DesignBiostatistics, Epidemiology and Research Design (BERD) • Develop new statistical methods • Develop, validate and integrate research designs and statistical methodologies • Innovative methods of enhancing the power of studies • Work with investigators to craft customized design and analysis plans • Connect with other resources to provide more extended statistical support ©2011 MFMER | 3117437-9

  10. Community Settings Office for Community-Engaged Research Also provides support for recruiting a diverse population of research subjects Mayo clinical practice Translating Comparative Effectiveness Research Into Practice (TRACER) Unit Community practices Practice-Based Research Network (PBRN) “Real World” research settingsHow can I access? ©2011 MFMER | 3117437-10

  11. Study Design – Research EthicsWhy would I need an ethics consultation? • "I am the principal investigator for an industry-sponsored clinical trial and would like to recruit subjects for this study from my practice. Do I need to worry about perceived or real conflict of interest?" • "What are the potential ethical implications of putting a human neuronal stem cell into the brain of a developing mouse embryo?" • "I have completed a study looking at genetic variations across several different populations, including some from Africa and Asia. I have identified a few variants, including variants for several behavioral traits. How should I report these findings?" ©2011 MFMER | 3117437-11

  12. Study DesignOther CTSA resources • Office of Research Regulatory Support • Rochester Epidemiology Project • Research Volunteer Resource • Research Subject Advocate • Volunteer registries People are lined up around the block to participate!! ©2011 MFMER | 3117437-12

  13. Core ResourcesTranslational Technology Cores • Immunochemical Core Laboratory • Immune Monitoring Core • Metabolomics Core • Survey Research Core • Pharmacogenomics Core ©2011 MFMER | 3117437-13

  14. Core Resources Specialized Phenotyping Facilities • Autonomic Physiology/Neurophysiology • Body Composition/Bone Density • Cardiovascular • Energy Balance • Enteric Physiology and Imaging • Imaging • Pharmacogenomics • Sleep ©2011 MFMER | 3117437-14

  15. Mobile Research Vehicle ©2011 MFMER | 3117437-15

  16. Data Management • Contributions to Institutional Bioinformatics and Biomedical Informatics • Three levels of electronic data capture capability • Medidata Rave • SAS DMS • REDCap ©2011 MFMER | 3117437-16

  17. Results – what now?Beyond publishing…. • Communicate results to volunteers and the community • RVR, OCER • Dissemination and implementation in practice • TRACER • Return of results and other ethical issues • Ethics resource ©2011 MFMER | 3117437-17

  18. CTSASupporting your career Academic Affairs Committee Grand rounds Assistance with mentoring and promotions Continuing education Funding opportunities Assistance with grant preparation e.g., OCER, BERD, Ethics, Helpline function, etc. ©2011 MFMER | 3117437-18

  19. CTSA – What you can do for us • Use our services • Cite the grant http://ctsa.mayo.edu Cite the Grant!

  20. Contacts http://ctsa.mayo.edu/contact/ctsa-contacts.html • Not sure who you should contact? Submit a general inquiry through our online contact form: https://forms.mayoforms.org/forms/up/ctsa_contact.cfm, or contact us by phone at 507-255-7101, internal (77) 5-7101. • Principal Investigator: Robert Rizza, M.D. • Associate Director and Co-Principal Investigator; Director — Community Engagement: David Warner, M.D. • Co-Principal Investigator; Director — Education Resources: Sherine Gabriel, M.D. • Co-Principal Investigator; Director — Research Resources: Sundeep Khosla, M.D. • Co-Principal Investigator; Director — Service Center:Robert Simari, M.D. • Director — Administration: Michael Pfenning • Associate Director — Administration: Cheryl Nelson • Operations Manager: Laura Meiners

  21. Questions & Discussion ©2011 MFMER | 3117437-21 ©2011 MFMER | slide-21 ©2011 MFMER | 3117437-21

  22. Regulatory Support Research ManagementPrograms Res. SubjectAdvocacyServices BiomedicalInformatics Study Coordinator Degreeand DiplomaPrograms Study Design and Biostatistics TranslationalTechnologyCores (TTC) Study Team Continuing Education Specialized Phenotyping Facilities Research Ethics Resource CTSA Executive Committee External AdvisoryCommittee ScientificReview Panels Robert A. Rizza, MD Mayo Clinic Director for ResearchCTSA Director and Principal Investigator Internal AdvisoryCommittee NovelMethodology David O. Warner, MD Mayo Clinic Associate Director for Clinical/Translational ResearchCTSA Associate Director and Co-PI CTSA Academic AffairsCommittee Pilot andFeasibility Michael A. Pfenning / Cheryl A. Nelson Administrators, Mayo Clinic Research Administrative ServicesCTSA Director / Associate Director of Administration Research Resources Review Panel (RRRP) Communications Consultative, Regulatory, and Informatics Services R. D. Simari, MDCo-PI and Director Education Resources S. E. Gabriel, MDCo-PI and Director ResearchResources S. Khosla, MDCo-PI and Director CommunityEngagement D. O. Warner, MDCo-PI and Director Scholarly Opportunity Award ClinicalResearchUnit (CRU) Saint MarysCharltonMobile PredoctoralPrograms PostdoctoralPrograms Community-Based Research Networks Translating Comparative Effectiveness Research into Practice (TRACER) Medical Student Programs CTS Masters and CertificatePrograms PhD & MD/PhDProgram in CTS KL2 Mentored Career DevelProgram Office for Community EngagedResearch(OCER) ResearchVolunteerResource (RVR)

More Related