The CTSA Program at NIH Opportunities for Advancing Clinical and Translational Research (2013) / Chapter Skim
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2 A Vision for the CTSA Program in a Changing Landscape
2 A Vision for the CTSA Program in a Changing Landscape
Pages 35-52
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This chapter begins by exploring some of these large-scale changes and their impact on clinical and translational research and concludes by describing a new vision for the CTSA Program and opportunities for the National Center for Advancing Translational Sciences (NCATS) to fulfill this vision.
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. Across the United States, momentum is growing in support of a learning health care system that promotes novel partnerships and collaborations around research networks and clinical and delivery system innovations to continually improve health care value.
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. Clinical and translational research are integral to a learning health care system, which relies on an "iterative innovation process designed to generate and apply the best evidence for the collaborative health care choices of each patient and provider; to drive the process of discovery as a natural outgrowth of patient care; and to ensure innovation, quality, safety, and value in health care" (Kemp, 2012, p.
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Office for Human Research Protections, will be necessary. AN EVOLVING CLINICAL AND TRANSLATIONAL RESEARCH ECOSYSTEM The clinical and translational research ecosystem currently involves researchers, funders, health care systems, research networks, health
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have led to greater protection of personal information, but also present challenges in the conduct of efficient and clinical and translational research by "restrict[ing] the manner in which health care providers may use and disclose health information for health research" (Pritts, 2008)
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Enhanced Collaboration A growing number of private and public institutions are collaborating to share limited resources for clinical and translational research activities. The resulting coordination is creating broader research networks, enhancing facilitation of investigator-initiated projects, and improving the validity of patient-centered research outcomes.2 It also has 2 For example, the NIH initiative PROMIS (Patient Reported Outcomes Measurement Information System)
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. The conduct of translational research in primary care settings can lead to improvements in patient care by directly evaluating the feasibility of an intervention or protocol (Calmbach et al., 2012; Fulda et al., 2011)
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As a result, patient advocacy groups, health care providers, and community organizations are assuming more active roles in processes related to peer review, research protocol design, recruitment and retention of participants in clinical research, and translation of findings back to the community. Studies of broader community involvement could strengthen evidence of the value of community participation and provide best practices of community engagement across all phases of clinical and translational research.
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In compliance with federal regulations governing human subject research,3 a number of multisite studies are choosing to use single IRBs to coordinate joint, multi-institution IRB review of research protocols. For example, the Central Institutional Review Board Initiative performs a single review of some National Cancer Instituteāsponsored multicenter protocols, allowing the local IRB to focus solely on ethical issues unique to local conditions (Millum and Menikoff, 2010)
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population require a strong commitment to achieving greater participation of underrepresented groups in clinical and translational research careers at both the investigator and patient care levels. Effective clinical and translational research requires teams of researchers that can traverse the divides between basic and clinical sciences and health care practice.
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CTSAs can play a substantial role in facilitating efforts to remediate limitations in the clinical and translational research ecosystem such as the following: challenges associated with first-in-human studies; limited recruitment and retention in clinical trials; the identification and measurement of health outcomes to assess intervention effectiveness; barriers to increasing awareness about research resources and potential research partnerships at the investigator and community levels; lack of incentives for team-based science; policy and regulatory challenges in developing full and substantive collaborations with industry and other partners; and ethical concerns (including related regulatory requirements) associated with the interplay between clinical research and practice.
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By providing infrastructure and innovations to accelerate clinical and translational research, an increasingly networked CTSA Program will increase its benefit to research and researchers across diseases, health conditions, age ranges, and health care delivery systems. To reach its potential in an ever-changing environment, the CTSA Program must build on its core strengths and successes and transform CTSAs from academic research homes to active hubs in a fully integrated network of clinical and translational research.
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2008. Translational research: Crossing the valley of death.
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. CTSA PIs (Clinical and Translational Science Awards Principal Investigators)
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physicians to be research participants: Lessons learned from the North Texas (NorTex) needs assessment study.
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2012. A community translational research pilot grants program to facilitate community-academic partnerships: Lessons from Colorado's Clinical Translational Science Awards.
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are transforming the way academic medical institutions approach translational research: The University of Michigan experience. Clinical and Translational Science 4(4)
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11-7782. http://www.atsdr.cdc.gov/community engagement/pdf/PCE_Report_508_FINAL.pdf (accessed April 2, 2013)
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