Clinical and Translational Science Award (CTSA) John F. Ennever Medical Director, CTO Director, RKSR

CTSA Part of the NIH “Roadmap” Re-engineering the Clinical Research Enterprise An Institutional “Home” for Clinical and Translational Sciences

The purpose of this initiative is to assist institutions to forge a uniquely transformative, novel, and integrative academic home for Clinical and Translational Science that has the consolidated resources to: 1) captivate, advance, and nurture a cadre of well-trained multi- and inter-disciplinary investigators and research teams; 2) create an incubator for innovative research tools and information technologies; and 3) synergize multi-disciplinary and inter-disciplinary clinical and translational research and researchers to catalyze the application of new knowledge and techniques to clinical practice at the front lines of patient care.

CTSA the numbers Current funding for GCRC, and certain other training grants Plus and additional $6 million/yr 5 year funding (caveats)

CTSA 12 Awards made 2006 ColumbiaUC San Francisco DukePennsylvania MayoPittsburgh OregonRochester RockefellerTexas, Houston UC DavisYale Eventually 60 awards Ultimately replace ~80 GCRCs

CTSA Fundamental difference from GCRC Irving Center for Clinical Research Irving Institute for Clinical and Translational Research (IICTR) No longer geographically-based Degree Granting Additional components

CTSA Components Research design, statistics, regulatory affairs Biomedical informatics Career development program In-patient, out-patient, and community subject accrual sites Core Labs Pilot project program

IICTR Components DNMR PCSR BMIR DBR RKSER CRC CER TTR TRANSFORM TER (there will be a test at the end)

Development of Novel C/T Methodologies Resource (DNMR) This is the home for a group of junior investigators, IICTR fellows, who are supported by the IICTR and are expected to be leaders in translational research on campus. They are supported by a group of more senior investigators who serve as mentors

Pilot and Collaborative Studies Resource (PCSR) This Resource will provide funds for Clinical and Translational (C/T) research at CUMC, including: Pilot Awards (50k) to junior investigators to develop pilot data Irving Prizes (150k) for C/T Research and for C/T Methodology The latter two awards would go to multi- or interdisciplinary groups of more senior investigators joining together for new research efforts.

Biomedical Informatics Resource (BMIR) This resource will develop and extend various informatics services to support collaboration and data sharing – a common portal Study workflow processes and identify inefficiencies and gaps Introduce informatics interventions Clinical – administrative Clinical Trials Management System (Velos) Collaborative technologies (Wiki) Evaluate interventions Frequency of use End-user acceptance Evaluate barriers

Design and Biostatistics Resource (DBR) This resource will: Provide long-term, collaborative input, into the design, conduct, and analysis of large epidemiologic studies and clinical trials. Offer short-term consulting support to smaller studies and pilot projects for study design, data analysis, and analytic interpretation. Participate in the production of research manuscripts, abstracts, and presentations with colleagues in the CUMC community. Assist colleagues from multiple disciplines in their pursuit of independent research funding by serving as co- investigators on multidisciplinary teams assembled for novel research proposals.

Regulatory Knowledge and Support and Ethics Resource (RKSER) This resource is developing an educational program that integrates ethical and regulatory issues and serves the diverse needs of the research community Provide consultative services for both regulatory (e.g., IRB, HIPAA, IND, IDE) and ethical issues. Practical training on Rascal

Patient & Clinical Interaction Resource (PCIR – dba CRC) This resource includes the inpatient and outpatient component of the old GCRC In addition, resources (i.e., research nursing support) will be made available to other clinical sites (e.g., ICUs, ERs) Working to streamline the application process – to integrate within Rascal for parallel, not serial reviews.

Community Engagement Resource (CER) A requirement of the CTSA grant application was a proposal to engage the community. This resource is charged with enhancing the participation of members of our community in research and in engaging local providers in research Will include an off site location to see research subjects

Translational Technologies and Resources (TTR) This is the old GCRC core lab with much, much more. Includes resources in: Biomarkers Clinical Genetics Imaging (PET, fMRI) Organic Synthesis Botanicals, phytochemistry Separate application process – not full GCTC application.

Research Education, Training & Career Development Resource This was initially RETCDR but became TRANSFORM This is both a physical place (the Center for Clinically Oriented Research Education – CCORE) and an educational program. MPOR Ph.D. Mentored scholars (K12 program)

Tracking & Evaluation Resource (TER) This is a resource that has been set up to assure that we are making measurable improvements in how clinical and translational research is done at CUMC.

Where to get information The temporary web address is: www://gcrcweb.cpmc.columbia.edu/ctsa If you want a copy of this PowerPoint, just me: