Clinical and Translational Science Awards (CTSAs) Future Directions and Opportunities for ACNP investigators

Clinical and Translational Sciences Awards 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.

CTSA Objectives: Speedy Discoveries to Improve Patient Care Develop a distinct discipline for clinical and translational science Provide opportunities and resources for original research on novel methods Develop translational technologies and knowledge base for the full spectrum Synergize partnerships with industry, foundations, and community physicians Train interdisciplinary teams

Clinical and Translational Science Awards (CTSAs) Goals are:  Educate the next generation of clinical researchers  Improve clinical research management  Build diversity in leadership  Assemble interdisciplinary teams  Enhance public trust  Forge partnerships with private and public health care organizations CTSAWeb.org

CTSAs Provide a National Consortium of Academic Health Centers – 55 to date

Trial Design Advanced Degree-Granting Programs Participant & Community Engagement Regulatory Support Biostatistics Clinical Resources Biomedical Informatics Clinical Research Ethics CTSAHOME NIH & other government agencies Healthcare & community organizations Industry A Typical Clinical and Translational Science Award (CTSA) has the Following Components Each CTSA academic health center will create a home for clinical and translational science

Particular Strengths of CTSAs: Biomedical Informatics Growing importance in medicine, biomedical research Emphasis in CTSA Critical mass of individuals working on projects of mutual interest

CTSA Tools: RESEARCH RECRUITMENT: Overview of ResearchMatch.org  A new ‘matching’ tool to help volunteers easily connect with research studies  An innovative national partnership to develop a centralized web-based recruitment registry  A free, complementary recruitment tool  Secure & promotes volunteer choice at all levels  Disease-neutral – Anyone residing in the US can join! What is it?What is it not?  The end-all solution to participant recruitment  A replacement for successful, existing recruitment efforts  A tool that permits ‘cold calling’ volunteers  A final product

ResearchMatch.org

A secure, web-based application designed exclusively to support data capture for research studiesA secure, web-based application designed exclusively to support data capture for research studies Intuitive interface for data entry (with data validation)Intuitive interface for data entry (with data validation) Includes audit trails for tracking data manipulationIncludes audit trails for tracking data manipulation Automated export procedures for seamless data downloads to common statistical packages (SPSS, SAS, Stata, R)Automated export procedures for seamless data downloads to common statistical packages (SPSS, SAS, Stata, R) Other features include branching logic, calculated fields data de-identification, and survey capabilitiesOther features include branching logic, calculated fields data de-identification, and survey capabilities For more information:For more information:

Public Private Partnerships CTSA-IP Portal: Web-based intellectual property search engine, currently a pilot test site, lists all licensable technologies for CTSAs and the NIH intramural programs: CTSA Pharmaceutical Assets Portal: facilitate the transfer of the investigational drugs and biologics for academic research: used to "match" academic research with pharmaceutical assets Join to 1)Directly request compounds of interest from participating pharmaceutical companies 2)Receive information from companies seeking collaborations on the repositioning of the "shelved” drugs 3) Forge collaborative relationships with your academic colleagues and pharmaceutical companies using previously unaccessible pharmaceutical assets

Investigator Support Services CTSA Homepage: The Resources forResources for ResearchersResearchers link allows investigators to search for resources they are interested in

CTSA Educational Initiatives All CTSAs have K-12 programs designed to provide salary support for junior clinical/translational researchers All CTSAs have Master’s level training in clinical research

Investigator Support Services All CTSAs have personnel dedicated to providing support/information to investigators campus-wide – Research “navigation”, regulatory support All CTSAs have Pilot Project funding programs

Resources for Researchers Building Connections e-Newsletter Communication Toolkit

Working Group Recommendations is to move the CTSAs to a new NIH Center: National Center for Advancement of Translational Sciences (NCATS): NIH Scientific Management Review Board 16