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Planning a National CTSA Evaluation November 13, 2007 Lori Mulligan, NCRR Margaret Ames, NICHD PowerPoint Presentation
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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

types of evaluations
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
national ctsa consortium evaluation purpose
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
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 evaluation steering committee composition
National CTSA Consortium EvaluationSteering Committee Composition

CTSA

Representatives

National CTSA

Evaluation

Steering Committee

NIH CTSA

Evaluation Subcommittee

Professional

Evaluators

national ctsa consortium evaluation steering cmte roles responsibilities
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
national ctsa consortium evaluation challenges
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
congressional interest
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
national ctsa consortium evaluation timeline
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
national evaluation goals of the ctsa program
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
national evaluation goals of the ctsa program1
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
national evaluation goals of the ctsa program2
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