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4 Crosscutting Topics
Pages 105-142

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From page 105...
... committee believes are integral to effectively advancing clinical and translational science: training and education, community engagement, and child health research. These efforts, along with the program's contributions in building infrastructure and providing a range of research resources, make the CTSA Program a unique national resource within the clinical and translational research landscape.
From page 106...
... . CTSA Training Awards and Programs Since the inception of the CTSA Program, the training of new clinical and translational science investigators has been an integral part of the program.
From page 107...
... , as well as core competencies in specific areas, including child health translational research, T1 research, academiaindustry drug development, and medical device innovation and technology transfer (CTSA Central, 2011)
From page 108...
... Innovative Curricula and Team-Based Education and Training The excitement and the challenge of clinical and translational science is that it requires approaches to training and education that are outside of traditional scientific fields. The focus on a truly team-based and interdisciplinary approach to science requires collaborations that go far beyond lip service and necessitates relationship building between and among professional schools (e.g., medicine, nursing, business, law, engineering, public health)
From page 109...
... . The goal is for translational scientists to have competencies related to key questions at each phase of the translational research cycle, including  Which problems will we tackle?
From page 110...
... . CTSA Program participation in this network could be a benefit to furthering CTSA mentoring opportunities.
From page 111...
... The objective should be to personalize training experiences to meet the needs and goals of individuals and focus on competency rather than on the absolute requirement of obtaining a master's or other advanced degree. This flexibility will be valuable in attracting and retaining KL2 scholars and TL1 trainees and may be particularly pertinent to clinician-scientists, who can play a major role in the clinical and translational research enterprise.
From page 112...
... Increasing Diversity and Growth of the Clinical and Translational Research Workforce To date, scholars, trainees, and mentors in CTSA programs lack diversity. The Westat evaluation showed that most mentors are white males, and most scholars and trainees are white females (Miyaoka et al., 2011)
From page 113...
... If the CTSAs are to be centers for innovations in clinical and translational research, they should also lead in innovations in mentoring and its evaluation, including assessment of the professional career trajectory of those who have participated in the training programs, creation of networking opportunities, active participation in national professional organizations, and commitment or intention of the scholars and trainees to engage in clinical and translational research. Two groups within the CTSA Program have begun related efforts to examine the components of career success for clinical and translation scientists and the metrics needed to assess individual and organizational progress.
From page 114...
... Community partner training generally appears rather informal across CTSA institutions. One example of a formal program is the Community Engaged Scholars Program developed and implemented by the South Carolina Clinical and Translational Research Center for Community Health Partnerships.
From page 115...
... 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;
From page 116...
... In this section of the chapter, however, when the word "community" is used, it denotes the people who seek and provide health care in community, academic, and private settings, as well as individuals and organizations working in communities to improve the health and well-being of local populations. Community engagement in clinical and translational research varies in terms of both level of engagement and the stage(s)
From page 117...
... . BOX 4-2 Examples of Community Engagement in Clinical and Translational Research For basic research (T0−T1)
From page 118...
... In the clinical trial phases of clinical and translational research (T2−T3) , community organizations can play a significant role in developing appropri ate research protocols, helping researchers understand the needs and cul ture of the patient population, and recruiting prospective research participants.
From page 119...
... , and Recommendations for Community Involvement in National Institute of Allergy and Infectious Diseases HIV/AIDS Clinical Trials Research (Community Partners, 2009) , along with the work conducted, for example, through the CTSA Program, the Community-Campus Partnerships for Health (CCPH)
From page 120...
... . On October 15, 2012, NCATS released an RFI focused on how community engagement research could be enhanced through the CTSA Program with the end goal being "the development of a research agenda that would leverage the community engagement capability of the CTSA institutions to solve critical roadblocks in the translational research process" and that would build "on the CTSA community engagement projects, collaborations, and infrastructure to facilitate the conduct of translational research" (NIH, 2012b)
From page 121...
... The CTSA Consortium has two main committees focused on community engagement -- Strategic Goal Committee 4, which focuses on "enhancing the health of our communities and the nation," and the Community Engagement Key Function Committee, which has eight working groups devoted to a range of related areas, including practicebased research network collaborations, health policy, resource development, and community partner integration (CTSA Central, 2013c)
From page 122...
... .  Principles of Community Engagement: an almost 200-page primer de veloped by a task force of the Community Engagement Key Function Committee.
From page 123...
... .  Scripps Translational Science Institute Community Engagement Pro gram: a partnership with the Scripps Whittier Diabetes Institute devel oped to improve prevention and treatment strategies for diabetes in a high-risk population -- individuals in the San Diego area with Mexican
From page 124...
... To date, a formal evaluation of the community engagement aspects of the CTSA Program as a whole has not been conducted. In recent stakeholder input provided by the Center for Community Health Education Research and Service and the CCPH, one respondent wrote that the lack of common metrics "hurts [the]
From page 125...
... research findings and health • Sustained university–community technology to community users collaborations • Funds/resources for seed • Creation of an ethical Changed participants: Ultimate Goal: grants and CEnR infra- framework • More subjects Better Population structure development in universities and • Novel methods • Greater diversity Health communities • Representative cohorts • Multiple dimensions • Increased trust • Multiple sub-populations FIGURE 4-1 A logic model to guide community engagement metrics. NOTE: CBOs = community-based organizations; CBRNs = community-based research networks; CE = community engagement; CEnR = community engagement research; IRB = institutional review board; IT = information technology; PBRNs = practice-based research networks.
From page 126...
... Throughout the study, the IOM committee heard overwhelming support for community engagement as an integral part of the CTSA program. An NIH working group on CTSA/NCATS integration, leaders of the CTSA Consortium, CTSA PIs, Congress, and a range of diverse stakeholders have all voiced support for the broad focus of the program, which encompasses the full spectrum of translational research, including
From page 127...
... Recommendation 6: Ensure Community Engagement in All Phases of Research NCATS and the CTSA Program should ensure that patients, family members, health care providers, clinical researchers, and other community stakeholders are involved across the continu um of clinical and translational research. NCATS and the CTSA Program should  define community engagement broadly and use this defini tion consistently in RFAs and communications about the CTSA Program;  ensure active and substantive community stakeholder partic ipation in priority setting and decision making across all phases of clinical and translational research and in the lead ership and governance of the CTSA Program;  define and clearly communicate goals and expectations for community engagement at the individual CTSA level and across the program and ensure the broad dissemination of best practices in community engagement; and  explore opportunities and incentives to engage a more di verse community.
From page 128...
... The IOM committee was specifically asked to look at child health research efforts in the CTSA Program and concluded that the program has placed an appropriate emphasis on accelerating clinical and translational research to improve child health. The lack of pediatric studies results from a number of factors.
From page 129...
... Its mission and goals are to provide a national forum to identify collaborative opportunities for facilitating clinical and translational research on child health; to set priorities for the development of collaborative efforts and standard approaches; and to coordinate CTSA-wide efforts on child health research (CTSA Central, 2012a)
From page 130...
... . This program allows research sponsors, industry representatives, or individual developers to pro pose and explore interest in a range of child health research studies (CTSA Central, 2012b)
From page 131...
... . Opportunities and Next Steps Leadership, Collaboration, and Evaluation in Child Health Research The CTSA Program, through CC-CHOC, has made important steps in streamlining and accelerating clinical and translational research specific to the neglected area of child health.
From page 132...
... Primarily because of the much smaller population affected with pediatric diseases, many of these diseases are "orphan conditions," yet they can be life limiting or result in lifelong mental, physical, or developmental disabilities. Because of the burden of these conditions, clinical and translational research is of special importance, and the IOM committee believes that the CTSA Program has placed an appropriate emphasis on accelerating clinical and translational research to improve child health.
From page 133...
... PowerPoint presented at Meeting 1: IOM Committee to Review the CTSA Program at NCATS, Washington, DC, October 29. http://www.iom.edu/~/media/Files/Activity%20Files/Research/ CTSAReview/2012-OCT-29/CTSA%20presentations/5-Brady%20CTSA%20% 20SGC4%20slides%20for%20%20IOM.pdf (accessed March 25, 2013)
From page 134...
... Remarks presented at Meeting 3: IOM Committee to Review the CTSA Program at NCATS, Washington, DC, January 24. Children's National Medical Center CTSI (Clinical and Translational Science Institute)
From page 135...
... PowerPoint presented at Meeting 2: IOM Committee to Review the CTSA Program at NCATS, Washington, DC, December 12. http://www.iom.edu/~/media/Files/ Activity%20Files/Research/CTSAReview/2012-DEC-12/2-1%20%20Jonathan% 20Davis.pdf (accessed February 18, 2013)
From page 136...
... PowerPoint presented at Meeting 3: Committee to Review the CTSA Program at NCATS, Washington, DC, January 24. http://www.iom.edu/ ~/media/Files/Activity%20Files/Research/CTSAReview/2013-JAN-24/Kelly %20Edwards.pdf (accessed April 10, 2013)
From page 137...
... 2012. Tracking the impact of the National Institutes of Health Clinical and Translational Science Awards on child health research: Developing and evaluating a measurement strategy.
From page 138...
... 2012. Clinical and translational research and community engagement: Implications for researcher capacity building.
From page 139...
... 2012. Children's health research: Role of the CTSA Program in pediatric drug development.
From page 140...
... PowerPoint presented at Meeting 3: IOM Committee to Review the CTSA Program at NCATS, Washington, DC, January 24. http://www.iom.edu/~/media/Files/Activity%20Files/Research/ CTSAReview/2013-JAN-24/Sarena%20Seifer.pdf (accessed March 22, 2013.
From page 141...
... 2008. The meaning of translational research and why it matters.


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