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

2. ©2011 MFMER | 3117437-2 Clinical and Translational Science Award Background 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”

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

4. ©2011 MFMER | 3117437-4 Clinical and Translational Science Award National 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

5. ©2011 MFMER | 3117437-5 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

6. Becoming a Translational Researcher Educational 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. ©2011 MFMER | 3117437-8 Lifecycle of a Research Protocol

9. ©2011 MFMER | 3117437-9 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 Study Design Biostatistics, Epidemiology and Research Design (BERD)

10. ©2011 MFMER | 3117437-10 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 settings How can I access?

11. ©2011 MFMER | 3117437-11 "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?" Study Design – Research Ethics Why would I need an ethics consultation?

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

13. Core Resources Translational 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. ©2011 MFMER | 3117437-15 Mobile Research Vehicle

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. ©2011 MFMER | 3117437-18 CTSA Supporting 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.

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

20. Contacts http://ctsa.mayo.edu/contact/ctsa-contacts.html 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. https://forms.mayoforms.org/forms/up/ctsa_contact.cfm Principal Investigator: Robert Rizza, M.D.Robert Rizza, M.D. Associate Director and Co-Principal Investigator; Director — Community Engagement: David Warner, M.D.Community EngagementDavid Warner, M.D. Co-Principal Investigator; Director — Education Resources: Sherine Gabriel, M.D.Education ResourcesSherine Gabriel, M.D. Co-Principal Investigator; Director — Research Resources: Sundeep Khosla, M.D.Research ResourcesSundeep Khosla, M.D. Co-Principal Investigator; Director — Service Center: Robert Simari, M.D.Service CenterRobert Simari, M.D. Director — Administration: Michael PfenningMichael Pfenning Associate Director — Administration: Cheryl NelsonCheryl Nelson Operations Manager: Laura MeinersLaura Meiners

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

22. CTSA Executive Committee Robert A. Rizza, MD Mayo Clinic Director for Research CTSA Director and Principal Investigator David O. Warner, MD Mayo Clinic Associate Director for Clinical/Translational Research CTSA Associate Director and Co-PI Michael A. Pfenning / Cheryl A. Nelson Administrators, Mayo Clinic Research Administrative Services CTSA Director / Associate Director of Administration Research Resources S. Khosla, MD Co-PI and Director Education Resources S. E. Gabriel, MD Co-PI and Director External Advisory Committee Internal Advisory Committee CTSA Academic Affairs Committee Community Engagement D. O. Warner, MD Co-PI and Director Pilot and Feasibility Research Resources Review Panel (RRRP) Scientific Review Panels Novel Methodology Community- Based Research Networks Translating Comparative Effectiveness Research into Practice (TRACER) Office for Community Engaged Research (OCER) Research Volunteer Resource (RVR) Predoctoral Programs Postdoctoral Programs Research Management Programs Clinical Research Unit (CRU) Saint Marys Charlton Mobile Medical Student Programs CTS Masters and Certificate Programs Translational Technology Cores (TTC) PhD & MD/PhD Program in CTS KL2 Mentored Career Devel Program Scholarly Opportunity Award Regulatory Support Research Ethics Resource Consultative, Regulatory, and Informatics Services R. D. Simari, MD Co-PI and Director Communications Study Team Continuing Education Study Coordinator Degree and Diploma Programs Specialized Phenotyping Facilities Study Design and Biostatistics Biomedical Informatics Res. Subject Advocacy Services