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Center for Translational Science Activities
(CTSA)
David Warner, M.D.
Associate Director and Co-PI, Mayo Clinic CTSA
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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”
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The Translational Research Continuum
“Bench”
Basic
Biomedical
Discovery
What is the effect
on population health?
T4
What works under
controlled conditions?
(Up to phase III trials)
T1
CTSA supports all
phases of translation
“Bedside”
Clinical
Efficacy
T2
What works in
real world settings?
(Outcomes research)
Clinical Practice
Community
Practices
T3
How can we
change practice?
(Dissemination and
Implementation Research)
Clinical
Effectiveness
Community
Practices
(e.g., Comparative
Effectiveness
Research)
Clinical and Translational Science Award
National Institutes of Health
• Develop and train the next generation of interdisciplinary 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
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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
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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
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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
Lifecycle of a Research Protocol
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Study Design
Biostatistics, 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
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“Real World” research settings
How can I access?
• 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)
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Study Design – Research Ethics
Why would I need an ethics consultation?
• "I am the principal investigator for an industrysponsored 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?"
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Study Design
Other 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!!
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Core Resources
Translational Technology Cores
• Immunochemical Core
Laboratory
• Immune Monitoring Core
• Metabolomics Core
• Survey Research Core
• Pharmacogenomics Core
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Core Resources
Specialized Phenotyping Facilities
• Autonomic Physiology/Neurophysiology
• Body Composition/Bone Density
• Cardiovascular
• Energy Balance
• Enteric Physiology and Imaging
• Imaging
• Pharmacogenomics
• Sleep
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Mobile Research Vehicle
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Data Management
• Contributions to Institutional Bioinformatics and
Biomedical Informatics
• Three levels of electronic data capture capability
• Medidata Rave
• SAS DMS
• REDCap
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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
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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.
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CTSA – What you can do for us
• Use our services
• Cite the grant
http://ctsa.mayo.edu
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.
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•
•
•
•
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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
Questions & Discussion
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CTSA Executive Committee
External Advisory
Committee
Scientific
Review Panels
Robert A. Rizza, MD
Mayo Clinic Director for Research
CTSA Director and Principal Investigator
Internal Advisory
Committee
Novel
Methodology
David O. Warner, MD
Mayo Clinic Associate Director for Clinical/Translational Research
CTSA Associate Director and Co-PI
CTSA Academic Affairs
Committee
Pilot and
Feasibility
Michael A. Pfenning / Cheryl A. Nelson
Administrators, Mayo Clinic Research Administrative Services
CTSA Director / Associate Director of Administration
Communications
Education
Resources
Research Resources
Review Panel (RRRP)
Consultative,
Regulatory, and
Informatics Services
Research
Resources
Community
Engagement
S. E. Gabriel, MD
S. Khosla, MD
D. O. Warner, MD
R. D. Simari, MD
Co-PI and Director
Co-PI and Director
Co-PI and Director
Co-PI and Director
Predoctoral
Programs
Postdoctoral
Programs
Research
Management
Programs
Medical
Student
Programs
CTS Masters
and Certificate
Programs
PhD & MD/PhD
Program in CTS
KL2 Mentored
Career Devel
Program
Study
Coordinator
Degree
and Diploma
Programs
Study Team
Continuing
Education
Clinical
Research
Unit (CRU)
Saint Marys
Charlton
Mobile
Translational
Technology
Cores (TTC)
Specialized
Phenotyping
Facilities
Scholarly Opportunity
Award
CommunityBased Research
Networks
Regulatory
Support
Translating
Comparative
Effectiveness
Research into
Practice
(TRACER)
Res. Subject
Advocacy
Services
Biomedical
Informatics
Office for
Community
Engaged
Research
(OCER)
Study
Design and
Biostatistics
Research
Volunteer
Resource (RVR)
Research
Ethics
Resource