The CTSA Program at NIH Opportunities for Advancing Clinical and Translational Research (2013) / Chapter Skim
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Program in 2006. The CTSA Program was designed to "provide integrated intellectual and physical resources for the conduct of original clinical and translational science," 1 and individual CTSA sites were intended to serve as "catalysts and test beds for policies and practices that can benefit clinical and translational research organizations throughout the country."2 In its first 7 years, the CTSA Program grew from 12 initial sites to the current 61, which are housed at academic health centers and other institutions across the United States.
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The committee's overarching conclusion is 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. THE CTSA PROGRAM The CTSA Program is a direct outgrowth of the NIH's General Clinical Research Center Program, which for more than 40 years provided clinical research infrastructure funding.
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The CTSA Consortium's efforts are guided by three leadership committees: an Executive Committee, a Steering Committee, and a Child Health Oversight Committee. In addition, CTSA principal investigators, researchers, and staff work on 5 strategic goal committees and 14 key function committees (plus a number of interest groups, task forces, and work groups)
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The IOM committee envisions a transformation of the CTSA Program from its current, loosely organized structure into a 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. The committee identified four key opportunities for action: Adopt and sustain active program leadership -- NCATS should increase its leadership presence in the overall program, con sistent with the cooperative agreement model under which the CTSAs are funded.
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Program efforts can also help over come the paucity of research specific to child health. LEADERSHIP Today's CTSA Program has a complex, multilevel structure of organization and oversight involving NCATS, individual CTSAs, the CTSA Consortium with multiple levels and type of committees and working groups, and the CTSA Coordinating Center.
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Recommendation 1: Strengthen NCATS Leadership of the CTSA Program NCATS should strengthen its leadership of the CTSA Program to advance innovative and transformative efforts in clinical and translational research. As it implements CTSA 2.0, NCATS should increase active involvement in the CTSA cooperative agree ments and the CTSA Consortium; conduct a strategic planning process to set measurable goals and objectives for the program that address the full spec trum of clinical and translational research; ensure that the CTSA Program as a whole actively supports the full spectrum of clinical and translational research while encouraging flexibility for each institution to build on its unique strengths; form strategic partnerships with NIH institutes and centers and with other research networks and industry; establish an innovations fund through a set-aside mechanism that would be used for collaborative pilot studies and other initiatives involving CTSA institutions, other NIH institutes, and/or other public and private entities (e.g., industry, other
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Recommendation 2: Reconfigure and Streamline the CTSA Consortium NCATS should reconfigure and streamline the structure of the CTSA Program by establishing a new multistakeholder NCATS CTSA Steering Committee that would be chaired by a member of NCATS leadership team and have a CTSA principal investigator as vice-chair, and provide direction to the CTSA Coordinating Center in devel oping and promoting the use of available shared resources. Recommendation 3: Build on the Strengths of Individual CTSAs Across the Spectrum of Clinical and Translational Research Individual CTSAs, with the leadership of NCATS, should em phasize their particular strengths in advancing the program's broad mission and goals.
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The evaluations should use clear, consistent, and innovative metrics that align with the program's mission and goals and that go beyond stand ard academic benchmarks of publications and number of grant awards to assess the CTSA Program and the individual CTSAs. CROSSCUTTING TOPICS The CTSA Program has demonstrated progress in three crosscutting domains that the IOM committee believes are integral to advancing clinical and translational science effectively: training and education, community engagement, and child health research.
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To better prepare the next generation of a diverse clinical and translational science work force, the CTSA Program should emphasize innovative education and training models and methodologies, which include a focus on team science, lead ership, community engagement, and entrepreneurship; disseminate high-quality online offerings for essential core courses for use in CTSA and other institutions; 3 The KL2 Mentored Clinical Research Scholar Program is a career development award that provides individuals who have a doctoral degree with formal research experience and funding support to help them become independent investigators in clinical and translational research. The TL1 Clinical Research Training Program provides an introduction to clinical and translational research to pre- and postdoctoral candidates or others who want to learn more about these types of research.
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Communities can contribute to the full range of clinical and translational research in important ways that are not always recognized. For example, partnerships with community representatives can identify community health needs and priorities, provide critical input and data on clinically relevant questions, develop culturally appropriate clinical research protocols, promote successful enrollment and retention of research participants, and, ultimately, disseminate and implement research results more effectively.
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The IOM committee believes that the CTSA Program has placed an appropriate emphasis on accelerating clinical and translational research to improve child health, and the CTSA Program, through the CTSA Consortium Child Health Oversight Committee (CC-CHOC) , has made important steps toward streamlining and accelerating this type of research.
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Implementing these types of strategies will allow researchers to understand what is occurring in clinical practice and will allow pediatric health care providers, patients, and families to learn about new medications, therapeutics, and preventive measures. Recommendation 7: Strengthen Clinical and Translational Research Relevant to Child Health NCATS should collaborate with the CTSA Consortium Child Health Oversight Committee to strengthen clinical and transla tional research relevant to child health through efforts to identify and designate CTSAs with expertise in child health research as leaders in advancing clinical and translational research relevant to child health and as coordinators for CTSA programwide efforts and other collaborative efforts in this research; and promote and increase community engagement specific to child health by o raising awareness of the opportunities for children and families to participate in research efforts with clear in formation conveyed on the risks and potential benefits; and o involving parents, patients, and family members more fully at all stages of the research process, including iden tifying priorities and setting research agendas.
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Because the CTSA Program is not disease specific in its orientation, strong collaborations must be forged across disciplinary units within individual CTSA institutions and with other NIH institutes and centers, as well as with other government funders, industry, philanthropies, and community organizations. The CTSA Program should continue to lead efforts in expanding and diversifying the research workforce and to coordinate and advance child health research by streamlining and building on the expertise of individual CTSAs.
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Strengthen clinical and translational research relevant to child health. _______________________________ a The full text of the recommendations appears throughout the summary and in Chapters 3 and 4 of the report.
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