Chapter 7: Organization and Oversight
With 60 academic health institutions, the national CTSA Consortium requires a dynamic organizational approach with multiple levels of oversight from NIH leadership, an advisory board, and CTSA steering and operational committees. These governing groups identify and address research barriers and work to implement best practices in clinical and translational research.
Advisory Board, Council and NIH Input
NIH leaders representing a wide range of institutes and centers provide expert advice to guide CTSA Consortium direction, structure and research efforts. Additionally, they inform the CTSA community of work supported by other NIH components, provide insight into lessons learned by other research centers and help reduce the potential for redundant efforts.
Steering and Oversight Committees
The CTSA Consortium Steering Committee (CCSC) is the core governing and decision-making body of the consortium. Comprising principal investigators from each CTSA site and representatives across NIH, it sets strategic direction and provides management oversight. Specifically, it determines priorities and goals, approves new projects, ensures progress, and develops and shares policies and procedures across the consortium. The CTSA Consortium Executive Committee includes representatives from the CCSC and functions to advise the NCRR director and steering committee.
The CTSA Child Health Oversight Committee serves as a national forum for CTSA investigators and NIH scientists to identify collaborative opportunities to facilitate pediatric clinical and translational research. This committee identifies barriers, sets priorities for developing collaborative solutions and standard approaches to the unique challenges in pediatric research, and recommends strategies to the CCSC that can be implemented across the consortium.
Strategic Goal and Operational Committees
The CTSA Strategic Goal Committees are responsible for achieving the goals identified by the consortium. These committees comprise principal investigators from the steering committee, representatives from CTSA institutions and NIH staff. Each committee identifies and prioritizes consortium-wide efforts to achieve the objectives and milestones of its respective strategic goal.
Working closely with the Strategic Goal Committees are the CTSA Key Function Committees, which focus on research areas or functions critical to the CTSA mission and enable information exchange across institutions. The composition, and number of these committees and groups, is dynamic so that they can flexibly respond to the needs of the CTSA community. They include representatives from CTSA institutions and the NIH. In 2011, a CTSA Coordinating Center was established by an NIH grant to facilitate consortium activities. The Coordinating Center administers the CTSA website at http://ctsacentral.org.
Special Areas of Focus
CTSA Thematic Special Interest Groups include participants from CTSA and non-CTSA institutions who share topics of specific interest and meet to discuss and collaborate based on that interest. These groups may already be formally or informally recognized as a topic-specific group outside of the CTSA community. Current groups include sleep research, dentistry and oral health, neuroscience, emergency care, and pain research.
CTSA Program Evaluation
Since the inception of the CTSA program, NIH has recognized the need and importance for a rigorous, independent program evaluation to determine its national impact on clinical and translational science. Because the CTSA program is a large, complex research initiative, its evaluation will include several phases to comprehensively assess its impact on the field of clinical and translational science.
Building on evaluation efforts by individual CTSA institutions, the NIH enlisted an external research firm in 2009 to independently evaluate the CTSA program over a three-year period in the areas of stakeholder engagement, field visits, publication analysis and surveys. Details about each of these areas follow:
- Engaging stakeholders
NCRR hosted a meeting in July 2010 that convened stakeholders and evaluators from NIH, CTSA institutions and the private sector to further engage stakeholders in the evaluation process. Stakeholders shared their perspectives on the CTSA evaluation and discussed the challenges of evaluating large, complex NIH initiatives, such as the CTSA program, made recommendations, and validated the direction of the national evaluation. - Conducting field visits
The evaluation team conducted field visits of a sampling of nine CTSA institutions that varied in geographic distribution, award size, award year and research emphasis. The team interviewed key CTSA staff, trainees, scholars, deans, administrators, evaluators and community group members to obtain information. - Analyzing publications
Evaluators conducted a preliminary analysis of published CTSA-cited research as reported in CTSA annual progress reports. Interim findings suggested that substantial co-authorship takes place between users and non-users of CTSA resources. There also is a high degree of interdisciplinary collaboration, particularly between clinical disciplines and other disciplines (e.g., public health, genetics). In addition, CTSA-supported investigators and scholars are publishing significant numbers of articles in high-impact scientific and medical journals, including the New England Journal of Medicine, JAMA, Nature and Science. - Quantifying data with surveys
Evaluators currently are conducting surveys to collect quantitative data on the use (as well as the lack of use) of CTSA research resources and the training and educational experiences at CTSA institutions. When complete, the data from these surveys will provide additional information about the use and availability of CTSA resources. Data also will illustrate the educational and training experiences of scholars, trainees and their mentors, as well as the impact on their careers and on the field of translational science.
Final results will be available in 2012; however, interim findings from three components — stakeholder engagement, field visits and publication analyses — suggest that CTSAs are helping to advance clinical and translational research at the local and national levels.
