The CTSA Program at NIH: The NCATS Advisory Council Working Group Response to the IOM Report

Earlier this summer, the National Center for Advancing Translational Sciences (NCATS) Working Group on the IOM (Institute of Medicine) released its report, The CTSA [Clinical and Translational Science Awards] Program at NIH. The report is the Working Group’s response to the recommendations in an IOM report regarding the National Institutes of Health’s (NIH) CTSA Program. The response included the Working Group’s acknowledgement that the CTSA program is key to the goal of “accelerating the process of transforming discovery into application and to increase the rate of adoption.” The CTSA program supports a national consortium of medical research institutes working together to improve the way that clinical and translational science is conducted.

The IOM report is the NIH’s response to Congress regarding the CTSA Program’s mission and strategic goals and whether changes were needed to the program. The agency sponsored an IOM consensus study to assess and provide recommendations on the appropriateness of the CTSA program which resulted in the IOM committee’s overarching conclusion that “the CTSA program is contributing significantly to the advancement of clinical and translational research and is therefore a worthwhile investment that would benefit from a variety of revisions to make it more efficient and effective.”

In the 2013 report to NIH, The CTSA Program at NIH: Opportunities for Advancing Clinical and Translational Research, the IOM committee noted that it “envisions a transformation of the CTSA Program from its current, loosely organized structure into one that is more tightly integrated network that works collectively to enhance the transit of therapeutics, diagnostics, and preventive interventions along the developmental pipeline; disseminate innovative translational research, methods and best practices; and provide leadership in informatics standards and policy development to promote shared resources.” It identified four key opportunities for action: (1) Adopt and sustain active program leadership; (2) Engage in substantive and productive collaboration; (3) Develop and widely disseminate innovative research resources; and (4) Build on initial successes in training and education, community engagement, and child health research (see Update, July 22, 2013).

Working Group’s Report

The NCATS’ Working Group distilled the IOM report into four strategic goals that broadly capture selected IOM report recommendations. From these, the Working Group identified measurable objectives:

1. Workforce Development – Building an environment that supports and values translational science as “the place to go” for those who want to pursue high-impact careers in health sciences; training and educating a world-leading, continuously learning workforce; and developing a translational science workforce that can meet the needs of today and tomorrow.
2. Collaboration/Engagement – Engaging stakeholder communities; enabling team science to become a major academic model; and ensuring that all translational science is performed in the context of collaborative team science.
3. Integration – Integrating translational science across the entire lifespan to attain improvements in health for all; launching efforts to study special population differences in the progress and treatment of disease processes; and developing a seamless integrated approach to translational science across all phases of research.
4. Methods/Processes – Enabling CTSA programs to function individually and together as a research engine transforming the way translational science is conducted; rapidly translating CTSA-generated new knowledge and technologies into health interventions; developing technologies, methods, data analytics and resources that change the way translational scientists approach their work; and generating and curating comprehensive data sets or other resources that catalyze science.

Moving forward, beginning in fiscal year (FY) 2015, NCATS intends to develop a number of new initiatives aimed at further strengthening the CTSA program, taking into account the IOM and Council Working Group reports. According to NCATS, the proposed set of initiatives will emphasize measurable progress in overcoming barriers to translational efficiency across the translational science spectrum and will include, but not be limited to, preclinical research, clinical research and training.

The report accompanying the Senate’s FY 2015 Labor, Health and Human Services, and Education, and Related Agencies (Labor-HHS) Appropriations bill commends NCATS for implementing the IOM’s recommendations on the CTSA program. It also directs NCATS to provide an update of its progress in the FY 2016 Congressional Justification. Additionally, NIH/NCATS is also urged to give funding to CTSAs with a history of serving health disparity populations and to give priority to applications that propose to conduct research in areas that “are characterized by geographically interspersed minority populations.”

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