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3 Leadership
Pages 53-104

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From page 53...
... Leadership opportunities and challenges facing the CTSA Program are outlined in this chapter with discussion and recommendations related to leadership strategies, organizational structure, collaborations and partnerships, leadership for individual CTSAs, evaluation, and communications. Leading the CTSA Program into its next phase, CTSA 2.0, will involve building on the strengths of individual CTSAs; leveraging the dedication of individuals working in clinical and translational science; and expanding successful collaborative endeavors, both within and outside of the National Institutes of Health (NIH)
From page 54...
... The individual CTSAs and the coordinating center are funded through cooperative agreements. The salient feature of cooperative agreements is that NIH staff members provide assistance to awardees "above and beyond the levels usually required for program stewardship of grants.
From page 55...
... Although the purpose and tasks of the two programs were widely different, a number of management and leadership lessons can be learned from the HGP that could be useful in the administration of the CTSA Program. For example, as with the HGP, a compelling vision, clearly articulated goals, and a mission-oriented approach could be used to organize and align the work of the individual CTSAs.
From page 56...
... In addition to the administrative critiques described in the report, the OIG found no evidence that NIH program staff provided the "substantial involvement" required by federal regulations and NIH policy with respect to cooperative agreements. In fact, OIG reviewers found no documentation of technical assistance by project scientists for any of the cooperative agreements.
From page 57...
... , more active NCATS leadership will require that it take on significant responsibilities in promoting collaborations, conducting evaluations of progress, and ensuring that the program leverages the innovations provided by each of the individual CTSAs and their researchers, leaders, staff, and partners. Striking the right balance between top-down and grass-roots leadership will not be easy, and a number of challenges and possible unintended consequences need to be carefully considered as changes are made to the governance and leadership of the program.
From page 58...
... In considering the appropriateness of the CTSA mission, the committee heard both support for preserving coverage of the full spectrum of clinical and translational research from T0–T4 and concern about the feasibility of doing so, given the limited available resources (IOM, 2013a)
From page 59...
... The committee concurs with NCATS's recent decision to allow increased flexibility for individual CTSAs in meeting program requirements, while ensuring that the CTSA Program as a whole continues to support the full spectrum of clinical and translational research. The current CTSA Program mission statement conflates mission and goals.
From page 60...
... For example, a CTSA fact sheet notes that "its goals are to accelerate the translation of laboratory discoveries into treatments for patients, to engage communities in clinical research efforts, and to train a new generation of clinical and translational researchers" (NCATS, 2012a) , and the recent RFA said that "the goal of the CTSA Program remains focused on integrated academic homes for the clinical and translational sciences that increase the quality, safety, efficiency and speed of clinical and translational research, particularly for NIH supported research" (NIH, 2012c)
From page 61...
... The health of our communities and the nation; and 5. T1 translational research (CTSA Central, 2013a)
From page 62...
... might be a useful strategy in assuring that relevant viewpoints about the program's mission and goals are considered. A particular benefit of the collaborative approach to developing plans for integrating the CTSA program into NCATS was the positive response from the individual CTSAs, which demonstrated their "deep commitment to the NCATS mission," willingness to move forward rapidly, and recognition of new opportunities that NCATS would create, including greater visibility and closer, more transparent working relationships with NIH institutes and centers (CTSA PIs, 2012)
From page 63...
... It now has three leadership committees (Executive Committee, Steering Committee, and Child Health Oversight Committee) ; committees charged with making progress on each of the 5 CTSA Consortium strategic goals; 14 key function committees, 10 thematic special interest groups, and numerous working groups and task forces under each of those committees.
From page 64...
... . A variety of collaborative informatics tools have been developed and are being disseminated through the Consortium Coordinating Center.
From page 65...
... . Opportunities and Next Steps Moving toward systems- and network-based approaches to resolving the challenges in clinical and translational research will require more hands-on leadership from NCATS than in the past; more focused, streamlined, and efficient centralized leadership of the program; and changes in its structure.
From page 66...
... This steering committee should oversee the Coordinating Center and a streamlined structure of consortium committees (see Figure 3-1)
From page 67...
... However, according to testimony received by the IOM committee and from interviews conducted as part of the Westat site visit evaluation, the current number and size of committees -- some having more than 150 members -- makes too many burdensome demands on researchers' time (Westat, 2011)
From page 68...
... Its inherent function is to initiate and foster collaborations -- including developing innovative tools, policies, and processes; removing barriers to research; training teams of investigators; engaging communities in the research process; and other efforts -- that bring together researchers, research networks, NIH institutes and centers, community stakeholders, health care providers, industry partners, government research agencies, and others to advance clinical and translational science. NCATS, the CTSA Coordinating Center, and the individual CTSA sites need to ensure that the full range of potential collaborators understands the value that the CTSA Program brings to clinical and translational research and that the Program is responsive to their needs.
From page 69...
... 1,000 Number of Grants Receiving CTSA Support 920 900 808 800 738 700 600 497 500 428 400 357 328 313 300 221 179 200 100 0 NHLBI NCI NIDDK NIAID NIMH NICHD NINDS NIA NIDA NIAMS NIH Institutes FIGURE 3-2 Top 10 NIH institutes and centers using CTSA resources. NOTE: NCI = National Cancer Institute; NHLBI = National Heart, Lung, and Blood Institute; NIA = National Institute on Aging; NIAID = National Institute of Allergy and Infectious Diseases; NIAMS = National Institute of Arthritis and Musculoskeletal and Skin Diseases; NICHD = National Institute of Child Health and Human Development; NIDA = National Institute on Drug Abuse; NIDDK = National Institute of Diabetes and Digestive and Kidney Diseases; NIMH = National Institute of Mental Health; NINDS = National Institute of Neurological Disorders and Stroke.
From page 70...
... They also jointly support pilot projects, faculty and staff recruitment and training programs, clinical research infrastructure, and community-based research through practice-based research networks, mobile clinical research units, and e-health programs (Weiss, 2012)
From page 71...
... . The IOM committee believes that many of the challenges in clinical and translational research must be solved using systemwide approaches and that the CTSA Program is well positioned, perhaps uniquely so, to facilitate and implement those approaches.
From page 72...
... . In a sense, this represents a scaling up of the program sites' success at building academic homes for clinical and translational research, reducing intradepartmental boundaries to collaboration, and developing regional collaborations (Briggs and Austin, 2012)
From page 73...
... The CTSA Program offers a venue and mechanisms for these types of partnerships, which are critical to the future of translational sciences. Another potential source of clinician partnerships is offered by the HMORN, a network of 18 U.S.
From page 74...
... 3 The Health Care Systems Research Collaboratory, housed at Duke University, is a coordinating center for a set of pragmatic randomized trials involving HMORN sites. The center is currently developing and disseminating collaborative research tools to the investigator community, including the NIH Distributed Research Network (Steiner, 2013)
From page 75...
... . At the IOM committee's December 2012 meeting, Jacqueline Fine of Merck Research Laboratories spoke specifically about collaborative opportunities in early phases of translational research (Fine, 2012)
From page 76...
... Opportunities and Next Steps Collaborations across and among researchers and research networks are core to building an integrated network that supports the work of clinical and translational science. Because the CTSA Program is a facilitator and accelerator of this research, NCATS, the CTSA Program, and individual CTSA sites need to ensure that they are working to initiate, nurture, and strengthen collaborations across CTSA institutions, with NIH institutes and centers, with private- and public-sector research institutions and networks, and with community stakeholders.
From page 77...
... The committee could not identify any data to quantify these institutional contributions but heard testimony from many individuals about the depth of efforts and the commitment to the CTSA Program from top leaders at health research institutions across the nation. In its first 7 years, the CTSA Program has done much to develop and nurture the CTSA sites as academic homes for clinical and translational research with an emphasis on training researchers, providing shared resources, streamlining and improving clinical research management, and developing community and research partnerships.
From page 78...
... The challenges ahead will be to capitalize on these efforts and refocus the program so that it becomes a network that is responsive, nimble, and innovative in accelerating clinical and translational research. The early funding announcements for the CTSA Program identified a set of key functions that evolved over time, some of which became a required part of the program.
From page 79...
... Thus the individual CTSAs and the program as a whole provide great potential to augment and facilitate the disease-specific work of NIH institutes and centers, as well as that of their home institutions (see Box 3-3)
From page 80...
... . Opportunities and Next Steps Individual CTSAs have made progress in establishing academic homes for clinical and translational research.
From page 81...
... Individual CTSAs are encouraged to identify and implement efficient and cost-effective ways to provide access to core facilities and resources. Further efforts are needed to promote awareness of their many resources, training, and services and to reduce their costs.
From page 82...
... Evaluating Individual CTSAs As part of the application process for a CTSA award, applicants are required to have a plan in place to  monitor the use, quality, and costs associated with the programs, resources, and services that are provided;  assess data and modify programs, resources, and services as nec essary in order to better meet the needs of researchers, increase quality and efficiency, and reduce costs; and  track and assess innovative methods and practices related to the structure, aggregation, and provision of services, programs, and resources (NIH, 2012c)
From page 83...
... Although flexibility in the evaluation approaches and processes of the individual CTSAs is appropriate given their variation in size, structure, and focus, some level of standardization is also needed. The National CTSA Evaluators Survey highlighted challenges related to a lack 6 For the last 3 years, the Shared Resources Working Group of the Evaluation Key Function Committee (described below)
From page 84...
... . The Evaluation Key Function Committee is attempting to develop common metrics in specific areas that could be used as benchmarks for individual CTSAs and the CTSA Program as a whole.
From page 85...
... NCATS's Role in Evaluating Individual CTSAs As part of their award obligations, CTSA sites must submit annual progress reports to NCATS, describing their accomplishments, milestones, challenges, and the barriers affecting their work. The Office of Management and Budget is requiring that the progress report format be updated and standardized across agencies; the new format will capture information on accomplishments, products, participants, impact, changes, special reporting requirements, and budget (NIH, 2012a)
From page 86...
... External evaluations by Westat provided quantitative and qualitative baseline measures for the program. That 3-year evaluation used site visits to assess training and education, resource utilization, publications, and the overall progress of individual CTSAs (see Box 3-4)
From page 87...
... : This report concluded that the CTSA Program is enabling a new research in frastructure and encouraging the adoption of new practices that have the potential to streamline the clinical and translational research process. Westat recommended that, going forward, the program should support institutional pilot programs, increase awareness of the program and available resources, expand education and training opportunities, streamline the CTSA Consorti um, increase incentives for collaboration and partnership, and conduct long term evaluations.
From page 88...
... . In addition, the NIH has produced two progress reports that cover accomplishments of individual CTSAs and the CTSA Consortium from 2006 to 2008 and 2009 to 2011 (NCRR, 2009; NIH, 2012b)
From page 89...
... In addition, there are multiple direct and indirect ways in which the CTSA Program contributes to research infrastructure and resources, collaborations, cultural changes, training, and community engagement that influence clinical and translational research but cannot be easily identified or measured. Despite these and other such challenges, the CTSA Program can be a leader in developing evaluation methodologies and metrics that could provide more real-time assessments of progress in advancing clinical and translational research, overcoming research barriers, fulfilling the program's mission and strategic goals, and, whenever possible, changing clinical care and improving public health.
From page 90...
... . The committee's Year in Review report highlights best practices from individual CTSAs in their use of a range of media, including social media, to highlight their work and attempt to educate the public generally about clinical and translational research (CTSA Central, 2013c)
From page 91...
... Finally, some communication activities are most effectively carried out by individual CTSA sites and projects. Box 3-5 provides examples of the opportunities at each of these levels.
From page 92...
... At an intermediate level (e.g., the CTSA Coordinating Center or communications-focused committee) ,  Provide consultation and support for individual CTSAs and projects in their website development, media outreach, and social media strate gies.
From page 93...
... CONCLUSIONS AND RECOMMENDATIONS The CTSA Program has made progress in fulfilling its task of strengthening the nation's infrastructure for clinical and translational science. In implementing the CTSA Program and moving it toward CTSA 2.0, NCATS has an obligation to ensure that the significant public investment that has been made thus far is effectively contributing to the research enterprise.
From page 94...
... As it implements CTSA 2.0, NCATS should  increase active involvement in the CTSA cooperative agreements and the CTSA Consortium;  conduct a strategic planning process to set measurable goals and objectives for the program that address the full spectrum of clinical and translational research;  ensure that the CTSA Program as a whole actively sup ports the full spectrum of clinical and translational re search while encouraging flexibility for each institution to build on its unique strengths;  form strategic partnerships with NIH institutes and cen ters and with other research networks and industry;
From page 95...
... 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 developing 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 emphasize their particular strengths in advancing the pro gram's broad mission and goals.
From page 96...
... The evaluations should use clear, consistent, and innovative met rics that align with the program's mission and goals and that go beyond standard academic benchmarks of publications and number of grant awards to assess the CTSA Program and the individual CTSAs. REFERENCES AHRQ (Agency for Healthcare Research and Quality)
From page 97...
... . CTSA Evaluation Key Function Committee.
From page 98...
... 2010. Linking Practice-Based Research Networks and Clinical and Translational Science Awards: New opportunities for community engagement by academic health centers.
From page 99...
... 2013. Heterogeneity at Work: Implications of the 2012 Clinical Translational Science Award Evaluators Survey: Where are we now?
From page 100...
... 2012c. Request for information: Enhancing the Clinical and Translational Science Awards Program.
From page 101...
... 2011. NIH administration of the Clinical and Translational Science Awards Program.
From page 102...
... 2010. Reengineering the national clinical and translational research enterprise: The strategic plan of the National Clinical and Translational Science Awards Consortium.
From page 103...
... Rockville, MD: Westat. Task Force on the Principles of Community Engagement (Clinical and Translational Science Awards Consortium Community Engagement Key Function Committee Task Force on the Principles of Community Engagement)
From page 104...
... http://weill.cornell.edu/news/ releases/wcmc/wcmc_2012/04_09_12.shtml (accessed March 1, 2013)


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