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National Center for Research Resources. NATIONAL INSTITUTES OF HEALTH. A c c e l e r a t i n g a n d e n h a n c i n g r e s e a r c h f r o m b a s i c d i s c o v e r y t o i m p r o v e d p a t I e n t c a r e. Planning a National CTSA Evaluation November 13, 2007
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National Center forResearch Resources NATIONAL INSTITUTES OF HEALTH A c c e l e r a t i n g a n d e n h a n c i n g r e s e a r c h f r o m b a s i c d i s c o v e r y t o i m p r o v e d p a t I e n t c a r e Planning a National CTSA Evaluation November 13, 2007 Lori Mulligan, NCRR Margaret Ames, NICHD
Grant Level Monitor progress of individual CTSA institutions through annual progress reports, self-evaluation reports, periodic site visits Program Level Evaluate the National CTSA Consortium Types of Evaluations
Evaluate short and long term effectiveness of the CTSA program Assess how the CTSAs function as a collective, national consortium Determine success/impact in transforming clinical and translational science within, across, and beyond Consortium Disseminate findings to Consortium, researchers, stakeholders, Congress, etc. National CTSA Consortium EvaluationPurpose
National CTSA Consortium Evaluation Multiple Inputs into Planning Process CTSA Evaluation Steering Committee External Advisors National CTSA Consortium Evaluation Other CTSA Steering Committees (i.e., Informatics, Translation, Education, etc.) Professional Evaluators (The Madrillon Group)
National CTSA Consortium EvaluationSteering Committee Composition CTSA Representatives National CTSA Evaluation Steering Committee NIH CTSA Evaluation Subcommittee Professional Evaluators
Coordinate institutional evaluation efforts with National CTSA Consortium Evaluation Develop and build consensusfornational metrics Identify and define baseline characteristics Adopt common terms and definitions across CTSA consortium as early as possible Exchange information (best practices, challenges, approaches, etc.) National CTSA Consortium EvaluationSteering Cmte Roles & Responsibilities
Recognize the novelty of CTSA program Acknowledge need forinstitutional flexibility Address impact of integrating existing programs Consider impact of changes with new cohorts and revised RFAs Manage public expectations: participants, stakeholders, Congress National CTSA Consortium Evaluation Challenges
Reauthorization NIH Reform Act of 2006 Funding/infrastructure for pediatric clinical research House & Senate Committee Report Requests: Support of Clinical Investigators (Due 3/1/2007) Support for pilot studies Clinical and Translational Research (Due 4/1/2007) Describe implementation of CTSA model and identify barriers GCRCs/CTSAs (Due 7/1/2007) Status of implementing and evaluating CTSA program Congressional Interest
July 2006 Established Trans-NIH CTSA Evaluation Subcommittee Oct 2006 Discussed evaluation plans at 1st CTSA PI Meeting Jan 2007 Awarded CTSA Evaluation Contract to MasiMax/Madrillon Group 1st National CTSA Consortium Evaluation Steering Committee Mtg July 2007 Congressional Appropriations Committee Report due Nov 2007 Feasibility study report Feb 2008 Planning for Process Evaluation 2ndNational CTSA Evaluation Steering Committee National CTSA Consortium Evaluation Timeline
Institution Scientist Consortium Assess the effectiveness of the CTSA to integrate clinical and translational science at the Institution Assess the recruitment, retention, and career advancement of clinical and translational science researchers Assess the effectiveness of an integrated national CTSA Consortium National Evaluation Goals of the CTSA Program
Consortium (continued) Science Assess the effectiveness of the National Institutes of Health as a partner with the CTSA Consortium Assess the acceleration of the translation of basic research into clinical studies Assess the acceleration of clinical studies into community practice National Evaluation Goals of the CTSA Program
Health Practice Community Assess the dissemination of new methods, tools, and resources into medical practice Assess the impact of the CTSA Consortium on improving public knowledge and involvement in clinical and translational research Assess the impact of the CTSA program on reducing morbidity and mortality National Evaluation Goals of the CTSA Program