The Connecticut Institute for Clinical and Translational Science (CICATS)

What is CICATS? The University of Connecticut, in partnership with regional hospitals, state agencies, and community health care organizations, has created the Connecticut Institute for Clinical and Translational Science (CICATS) to transform the way biomedical science is conceived, conducted and disseminated in Connecticut.

The Connecticut Institute for Clinical and Translational Science (CICATS) CICATS Cores Basic Science Education & Training Biostatistics Gateway Biomedical Informatics Pilot Program Community Engagement Regulatory Support Clinical Research Center Tracking & Evaluation

Investigator Resources The Connecticut Institute for Clinical and Translational Science (CICATS) CICATS Gateway Investigator Resources

Mission The Gateway is the “front door” for investigators seeking CICATS services and support. We offer referrals, tools, information and programs for investigators initiating and planning clinical and translational research projects. Goals Inform, educate and engage Networking and collaboration Facilitate access to research services

One-stop Shopping Investigator Advocate Regulatory Analyst Navigation Referral and Consult Team-building Research Planning Regulatory Analyst Regulatory Core Liaison to CICATS IRB Technical Assistance on-site Biostatistics Support Biostatistics Team with IA and RA to enhance research planning Consulting and Services on-site

Services & Programs Research Support Referral and team development Listserv, newsletter, website Seminars and workshops On-line toolkit Design Laboratory

Research Toolkit Research Process Guidance Electronic tool Coming Soon – Fall 2011

Research Toolkit

Design Laboratory Feedback for Investigators Planning Clinical and Translational Research Proposals Present proposal to expert panelists Range of expertise, including study design and statistics Presentation Discussion Written Feedback Feedback Investigator incorporates feedback into proposal Gateway referral services as needed Revisions

Networking & Collaboration Profiles Research Networking Tool Set up your profile and publication list Search for research partners by expertise Connect with other investigators

Profiles Research Networking Software

What is Translational Research? Using knowledge from basic science to produce new drugs, treatments, or prevention strategies. Moving treatments, interventions, or “best practices” to the public sector where they may be implemented to improve health. Reduce the gap between discovery and practical application

Translational Research: The Spectrum BENCH PRACTICE BEDSIDE Basic Science Research Preclinical Studies Animal studies Human Clinical Research Controlled observational Studies Phase 3 clinical trials Clinical Practice Delivery of recommended care Identification of new questions T1 Phase 1,2 clinical trials T2 Practice-based Research Phase 3, 4 trials Observational studies Survey Research Guideline Development Meta-analysis Systematic review Adapted from Westfall, J., Mold, J., Fagnan, L. (2007) Practice-Based Research: Blue Highways on the NIH Roadmap, JAMA 297 (4): 403-406. “T3” Dissemination & Implementation

Conclusion The Gateway is and important resource for investigators or trainees seeking CICATS services or trying to navigate the research process.

CICATS Regulatory Regulatory Resources

Mission The overarching purpose of the Regulatory Core is the protection of human subjects and their protected health information (PHI). Goals & Support: Regulatory support Regional CICATS IRB Education & guidance Clinical research ethics consulting

Conclusion The CICATS Regulatory Core is available for assisting investigators in all matters of regulatory compliance. Contact: Stacey Anderson Phone: 860-679-6213 Email: sanderson@uchc.edu

CICATS Biostatistics Center Biostatistics Services

Mission The Biostatistics Center is the primary resource for providing biostatistical collaboration and support for researchers throughout the UConn Health Center and CICATS partner institutions Goals Provide support for grant development that leads to externally funded grants and ongoing research collaboration Consult with researchers to identify best analysis strategies, study design and power analysis Mentor students and physician-scientists in training Provide statistical analysis services (fee for service)

Grant Development Statistical support leading to ongoing collaboration Statistics Plan Power Analysis & Sample Size Complete “Statistical Considerations” Grant Sections NIH and externally funded grants Statistical support leading to ongoing collaboration

Consultations with researchers Identify best analysis strategies Study design Power analysis Sample size

Biostatistics Training & Mentoring Students Masters Theses Doctoral Dissertations Colleagues Physician-Scientists in Training K-12 Awards

Other Services (fee for service) For existing funded projects the Biostatistics Center can provide on a fee for service basis: SAS Programming Statistical Analysis Manuscript Preparation Report Generation Data Base Development

Conclusion The CICATS Biostatistics Center is available for assisting investigators in all phases of their research. We look forward to collaborations with researchers. James Grady, DrPH jgrady@uchc.edu

CICATS Clinical Research Center Clinical Research Center (CRC)

Mission The CRC is a comprehensive center providing services in support of high-quality patient-oriented research at the UConn Health Center and affiliated hospitals. Goals Provide a wide range of administrative, clinical, laboratory and data management services for federally funded, foundation-funded, and industry-supported studies Ensure the ethical treatment and safety of research subjects and the scientific merit of clinical studies

Clinical Research Center Complete “Appendix A” form Apply as either: 1. Partially-funded (pay 80%) or 2. Fee-for-service (pay 100% of the cost of the requested service) Core Directors available to discuss a project’s specific needs Applying for CRC resources

Clinical Research Center Study Coordination RN/RA/MA Services Dental Operatory DEXA (Bone Densities) Recruitment IRB/IND/CoC Application Clinical Core

Clinical Research Center Sample Processing and Storage DNA and RNA Isolation Protein Analysis by Immunoassay (Elisas/RIAs) Genotyping and RNA Analysis Core Lab Services

Clinical Research Center Database consultation Double data entry Case Report Form design Interactive Voice Response (IVR) survey creation and management Custom application development Informatics Services

CICATS Education & Training Master of Science in Clinical & Translational Research Program Anne Kenny, MD, Program Director

Master of Science in Clinical & Translational Research Program Goals Competitively prepares health care professionals with academic and research skills needed for independent research. Focus: Preparation of individuals with established, terminal degrees in a health related field (MD, PhD, Pharm.D., DDS or DMD) to conduct independent research in translation of information from the basic sciences to the community as researchers, teachers, public health administrators, clinicians, and industry employees competent to carry out the broad health mission of the State of Connecticut.

THANK YOU…