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 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. Collaboration Breaking Down Institutional Barriers Team Science ConnectivityPartnerships CTSA Philosophy

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 OSU CCTS Values

Basic Science Discovery Clinical Research Translation Community Translation Best Practices Increase research efficiency Faster adoption of new findings to patient care T1T2 The Challenges for Clinical and Translational Research 17 years

Create an academic discipline of clinical and translational science to accelerate the transition of basic discovery to best practices Overarching Goal Objectives Create and support new teams Increase efficiency through integrating research infrastructure Support innovation Integration of Clinical and Translational Science

Specialized cores Enhance Efficiency Through Advances in Clinical and Translational Research Infrastructure Study Design IRB Submission Recruitment Community Dissemination Results Budgeting Study Implementation Community Input Basic Science Discovery Input Design and Team Development Regulatory Project Management Recruitment Clinical Research Center, PBRN, Community Partners Scientific cores Data management Biomedical Informatics Biostatistical Analysis Grants and Contracts IP and Tech Licensing

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 Linking basic science with clinical research Methodologic research –Support creation of biorepository and further development of tools for deep phenotyping within IW* 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 * 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 (picogram- nanogram 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 ( and become a CCTS memberwww.ccts.osu.edu Log in and fill out a Request for Resources Or, contact the Research Concierge

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

Instant Messenger How do you contact the Research Concierge?

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