Transcript CCTS PowerPoint-04-27-10 - Center for Clinical and Translational

Academic Home for
The Ohio State University
Clinical and Translational Science Award
Impetus for the CTSA Program
To ensure new discoveries lead to
improved public health, clinical science
must evolve to better:
 Implement biomedical discoveries.
 Develop, test, and bring new
prevention strategies into medical
practice more rapidly.
 Catalyze change - lower barriers
between disciplines.
 Encourage creative and innovative
approaches.
Sharing a Common Vision
Team Science
Connectivity
Partnerships
CTSA Philosophy
Breaking Down
Institutional Barriers
Collaboration
Working together as a
national consortium, CTSA
institutions share a common
vision to improve human
health by transforming the
research and training
environment to enhance the
efficiency and quality of
clinical and translational
research.
OSU CCTS Values
•
transformative of an academic culture to support the
development of a discipline of clinical and translational science
•
innovative by supporting new teams and research
methodologies to apply to heath research opportunities
•
inclusive by engaging faculty, staff and students from the 7
Health Sciences Colleges and the University community who
share a common vision about clinical and translational science
•
responsive to needs and emerging priorities
•
transparent in factors considered in resource and activity
allocation
The Challenges for Clinical and
Translational Research
17 years
Basic Science
Discovery
Clinical Research
Translation
T1
T2
Community
Translation
Best Practices
Increase research efficiency
Faster adoption of new findings to patient care
Integration of Clinical and Translational Science
Overarching Goal
Create an academic discipline of
clinical and translational science
to accelerate the transition of
basic discovery to best practices
Objectives
Create and support new teams
Increase efficiency through
integrating research infrastructure
Support innovation
Enhance Efficiency Through Advances in
Clinical and Translational Research Infrastructure
IP and Tech
Licensing
Community
Input
Grants and
Contracts
Biostatistical
Analysis
Budgeting
Biomedical
Informatics
Study Design
IRB
Submission
Recruitment
Basic Science
Discovery
Input
Design and
Team
Development
Study
Implementation
Community
Dissemination
Results
Specialized
cores
Regulatory
Project Management
Recruitment
Clinical Research Center,
PBRN, Community Partners
Scientific cores
Data management
What Does the CCTS Have Available To Support My Career?
•
Everyone
–
Education, training and career
development
•
•
•
Seminars
Special focus groups
TL1 (pre and post-doctoral) and
KL2 (clinician scientist) trainee support
MPH in clinical and translational science
Formal mentoring programs (and mentor
training)*
Graduate interdisciplinary specialization in
biomedical, clinical and translational science
(IBGP)*
•
•
•
–
–
•
•
–
–
–
–
–
–
–
–
Research networking tools*
Informatics tool kits
T1 investigators
–
–
–
–
–
MS and PhD in Translational Science
Biostatistics study design for grant
submission
Integration with clinical research teams
New drug discovery and comparative
animal cores
Pilot funding initiatives
•
•
–
Clinical Research Investigators
•
Biostatistics and ethics study design
Regulatory expertise and assistance
Recruitment Office
Access to research nurses and study
implementation through CRC or PBRN
Specialized cores for laboratory processing,
nutrition analyses and body (musculoskeletal)
composition
Pilot funding initiatives
Development of imaging core next year*
Development of training opportunities for
research staff*
T2 investigators
–
–
PhD in Implementation Science*
Toolkit supporting community-based
participatory research
•
–
Community partners and sites
Community engagement pilot funding
Linking basic science with clinical
research
Methodologic research
Support creation of biorepository and
further development of tools for deep
phenotyping within IW*
* Under development
CCTS Programs and Cores
Biostatistics and Research Design
• Support for design, analysis and proposal preparation
o Clinical trial design
o Laboratory experimental design
o Microarray data analysis
o Modeling of complex data
• Consultation for ethical and regulatory issues
• Develop and implement new statistical methods
specifically for C/T research
• Free biostatistics walk-in clinic
Thursdays, 11:00-1:00 pm
CCTS, Suite 205 Prior Health Sciences Library
Biomedical Informatics
• Perform consultation on:
– Informatics requirements analysis and project planning
– Database design, optimization and development
• Facilitate access to data stored in the OSUMC Information Warehouse
• Provide access to and support of tools enabling:
– Research data collection and management, including REDCap and StudyTrax
– Creation and management of web-based surveys, including REDCap Survey
– Research networking, including Microsoft Office Sharepoint Server (MOSS)
• Facilitate data integration via
– Development and management of grid computing infrastructure (TRIAD)
– Provision of comprehensive knowledge engineering services
• Provide training and education programs for supported tools, data
modeling, grid services creation and biomedical informatics
Translational Technologies and Core Resources
•
Drug discovery
o Chemical and radiochemical support services for drug discovery
o Pharmacoanalytic instrumentation for support of PK/PD studies
in Phase I-III clinical drug development
•
Laser capture microdissection (LCM) molecular core
o Sample preparation for LCM including staining, LCM, proteomics,
genomics, microRNA analysis on micro-samples (picogramnanogram quantities)
•
•
Biomedical Imaging Resource
Comparative Animal Core
o Animal tissue biorepository
o Mouse phenotyping and pathology
o Veterinary clinical trials office
CE squared: CE (Community Engagement) and
CER (Comparative Effectiveness Research)
• Pilot funds for CER research studies
• Assistance in design, methods and community
assessment/partnership
• Training opportunities including a national conference
which brings together investigators and stakeholders
• Comparative Effectiveness Research training supplement
grant pending
Pilot and Collaborative Studies
• Requests for applications (RFAs) to support new or
early stage investigators or new teams of established
researchers
o To date, 48 pilot grants funded
• Leverage CCTS pilot funds with collaboration from
other programs and centers to create additional
research opportunities
– Partner with Fisher College of Business for series of
5 workshops “Discovery, Innovation and
Commercialization”
• Assist with research team building
Tracking and Evaluation
•
•
•
•
•
•
•
Outcomes assessment including non-clinical and social
Health economics analysis
Healthcare policy analysis
Social network analysis
Survey research
Lean and Six Sigma approaches to process and quality
improvement
Implementation science research
Regulatory Knowledge and Ethics
•
•
•
•
Provide support to research teams to fulfill human
subject research regulatory requirements without the
loss of their sense of responsibility
Establish educational modules as well as standardized,
tiered training curricula for researchers and coordinate
current educational efforts
Assist with development of and participation in data
safety monitoring activities
Research Subject Advocate for IRB and/or PI requested
protocols
Clinical Research Center
• OSU research unit providing both inpatient and
outpatient services including nursing staff and
bionutrition facilities and expertise
• Exercise physiology and body composition
laboratories
• Specimen processing and core laboratory
• Specialist in recruitment and retention of research
participants including ResearchMatch.org
• Clinical trial protocol and budget development
Nationwide Children’s Hospital
Clinical Research Services
• 4000 sq ft Clinical Research Center at NCH
• Research Nurses, Coordinators and IRB Support
• Overall study management provided by extensively trained
research coordinators
• Research project consultation and study design assistance,
clinical research budget development
• Data Collection for subject tracking to ensure proper
invoicing and revenue capture
• Clinical Research Training
• Psychometric evaluation
• Investigators have access to all of the services provided
by NCH
Research Education, Training
and Career Development
• Developing a dynamic curriculum in clinical and translational
science (example: PH795)
• Provides research education resources and training including
workshops, podcasts, online resources, seminars
• Mentoring workshops*
*Under development
How do I access the CCTS programs and resources?
•
Visit the CCTS website (www.ccts.osu.edu) and
become a CCTS member
•
Log in and fill out a Request for Resources
•
Or, contact the Research Concierge
www.ccts.osu.edu
Research Concierge
•
Facilitate access to CCTS programs and cores
•
Locate OSU/NCH resources, cores and expertise
•
Assemble new research teams
•
Assist with navigation of OSU research infrastructure
•
Vendor information for equipment, instruments,
supplies, etc.
•
Information on funding opportunities including pilot
grants
How do you contact the Research Concierge?
614-366-7367
Instant Messenger
[email protected]
Leveraging the unique
talents and expertise across
OSU, the CCTS is fitting
together the pieces of a
puzzle of basic science
discovery and clinical
research to improve health
outcomes for each individual
in the community