Clinical and Translational Science Awards (CTSA) Anthony Hayward October 30, 2007
Vision for the CTSA Program • Strengthen Clinical Research as an academic discipline by creating a ‘home’ and a career structure. • Support the clinical and translational researcher through provision of resources that are most needed. • Speed clinical and translational research through resource and data sharing. • Advance the safety and quality of research through adoption of good clinical practices and effective use of informatics.
Each academic health center will create a home for clinical and translational science NIH & other government agencies Clinical Research Ethics Trial Design Advanced Degree-Granting Programs Biomedical Informatics CTSA HOME Industry Clinical Resources Participant & Community Involvement Biostatistics Regulatory Support Healthcare organizations
Building a National CTSA Consortium WA ME MT ND VT MN OR NH ID WI NY MA SD RI WY MI CT NJ IA PA NE NV OH DE IN IL UT MD CO WV VA KS MO CA KY TN AZ OK AR SC NM GA AL MS TX LA AK FL HI Participating Institutions Since 2006 Since 2007
The transformation process • In 2005, 66 universities were associated with 78 GCRCs where 14,760 investigators had 9257 protocols: 3245 publications were reported • By 2011 NCRR expenditure on clinical research infrastructure will rise to $500M from $333M. • Infrastructure/training support increase by ~ 40% • Transformation to integrated consortium • GCRCs had Research Subject Advocates – CTSAs designate their own preferred individual.
Organization of CTSAs • Include an institution that can award higher degrees in clinical research • Include research education and career development activities • Cooperative agreements ensure that awardees work together as a consortium • CTSAs send representatives to steering committees and workgroups
Consortium Governance & Organization Governance Manual available at http://ctsaweb.org/Docs/CTSA_Governance_Manual.pdf
CTSA Steering Committees and Workgroups • Embody the expertise of the Consortium • Provide a forum for dialogue with the NIH • Identify needs, goals and priorities • Serve as a platform to adopt common standards • Have deliverables and timetables
Alternative IRB models workgroup Created to: • Identify conditions favorable for pilot projects to test alternative IRB models • Share experience with regional reciprocity and common IRBs • Promote common consent language • Develop metrics and identify roadblocks • Address IRB differences e.g., in pediatrics