3

Leadership

As envisioned by the Institute of Medicine (IOM) committee, the Clinical and Translational Science Awards (CTSA) Program has the potential to overcome many bottlenecks and pioneer new solutions that can be used to accelerate clinical and translational research. Accomplishing the tasks ahead, however, will require a revitalized approach to program leadership—one that builds on the academic homes that have been established and moves toward an integrated network of CTSAs that increasingly applies collaborative and systems-based approaches. 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).

LEADERSHIP STRATEGIES

Balancing the tensions and benefits of two seemingly contradictory approaches to leadership is one of the challenges inherent in an endeavor with the scope and structure of the CTSA Program. A variety of possible advantages and disadvantages exist for differing leadership approaches. For example, the grass-roots approach to leadership offers the potential for creativity and innovation. It harnesses the dedication and energy of multiple researchers and stakeholders, all with an interest in moving clin-



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3 Leadership As envisioned by the Institute of Medicine (IOM) committee, the Clinical and Translational Science Awards (CTSA) Program has the po- tential to overcome many bottlenecks and pioneer new solutions that can be used to accelerate clinical and translational research. Accomplishing the tasks ahead, however, will require a revitalized approach to program leadership—one that builds on the academic homes that have been estab- lished and moves toward an integrated network of CTSAs that increas- ingly applies collaborative and systems-based approaches. 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, lead- ership 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 indi- viduals working in clinical and translational science; and expanding suc- cessful collaborative endeavors, both within and outside of the National Institutes of Health (NIH). LEADERSHIP STRATEGIES Balancing the tensions and benefits of two seemingly contradictory approaches to leadership is one of the challenges inherent in an endeavor with the scope and structure of the CTSA Program. A variety of possible advantages and disadvantages exist for differing leadership approaches. For example, the grass-roots approach to leadership offers the potential for creativity and innovation. It harnesses the dedication and energy of multiple researchers and stakeholders, all with an interest in moving clin- 53

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54 THE CTSA PROGRAM AT NIH ical and translational research forward, but all of whom also have ties and obligations to their home institutions. The top-down leadership ap- proach offers the potential for a systems-level perspective, greater focus and direction, and a commitment to progress for the overall research en- terprise. However, this approach usually means fewer people will have direct decision-making responsibilities, and it requires careful oversight and coordination to ensure that multiple people and projects are on track and working to meet the same goals. Finding the correct balance between these two approaches will be an important element for future CTSA success. As CTSA 2.0 moves forward, the IOM committee sees the need for a more centralized approach to leadership, one in which National Center for Advancing Translational Sciences (NCATS) plays a more active role. To date, the program has, for the most part, relied on the energy and ef- forts of individual CTSAs and their principal investigators (PIs). This has created a largely ad hoc structure and process for identifying next steps and overall management. Direction from the NIH (first through the Na- tional Center for Research Resources [NCRR] and more recently through NCATS) has been articulated primarily through the funding announce- ments. With each cycle of applications for new CTSAs or renewals, these announcements have emphasized specific key functions or priorities for the investigators to include in their applications. The mechanism by which the CTSA Program is funded gives NCATS the opportunity to lead awardees toward fulfilling the NIH’s vision for the program both in the performance of individual institutions and in the program’s overall achievements. The NIH has three funding mechanisms for making research awards—grants, contracts, and cooper- ative agreements. The individual CTSAs and the coordinating center are funded through cooperative agreements. The salient feature of coopera- tive agreements is that NIH staff members provide assistance to award- ees “above and beyond the levels usually required for program stewardship of grants. This level of stewardship is known as substantial involvement” (OIG, 2011, p. i). Substantial involvement can be achieved through various means, including technical assistance, advice, and coor- dination, and the most recent request for applications (RFA) for the CTSA Program noted that “substantial involvement means that, after award, NIH staff will assist, guide, coordinate, or participate in project activities” (NIH, 2012c). Cooperative agreements provide the structure and mechanisms with which NCATS can exert a stronger leadership role while also promoting collaboration and innovation by individual CTSAs and researchers and

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LEADERSHIP 55 guiding the program forward. As described throughout this chapter, the IOM committee urges NCATS to take a more active role in the direction and oversight of the CTSA Program. A number of lessons can be learned from a report on the program’s early experience that was prepared by the Department of Health and Human Services’ (HHS’s) Office of the In- spector General (OIG) (discussed below), as well from insights gained from the management of other collectives of academic institutions work- ing toward specific goals, such as the Human Genome Project (HGP). Although there are several differences between the HGP and the CTSA Program, they share many common elements, such as the following:  an emphasis on innovation, supported by the development of new technologies and databases;  the expectation of useful, actionable results and a need for ongo- ing evaluation;  an emphasis on efficiency and timely outcomes;  the development of a parallel research effort in bioethics and, in the CTSA case, community involvement; and  a commitment to collaborative, team-based science and to wide- ly sharing tools and results. An analysis of the management of HGP identified five key factors in the project’s success. HGP had (1) a clear goal; (2) a flexible organiza- tional structure (the “bottom-up” approach); (3) political support; (4) competition; and (5) strong leadership (the “top-down” approach) (Lambright, 2002). The Lambright analysis of the program says that, of these factors, “the fifth was the most important because it pulled the oth- er factors together and made the most of them when it counted” (2002, p. 5). Leadership manifested in different ways over the life of the project and ultimately provided a balance between the top-down and bottom-up leadership approaches that not only promoted flexibility and innovation but also provided the direction and oversight needed to achieve outcomes. Although the purpose and tasks of the two programs were widely dif- ferent, 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 or- ganize and align the work of the individual CTSAs. In addition, the com- bination of flexibility and active leadership that was used in the HGP to promote innovation and excellence in a pool of talented, multidiscipli-

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56 THE CTSA PROGRAM AT NIH nary researchers collaborating across multiple research centers is also applicable to the CTSA Program. Although collaboration was a key element of the HGP, the types of collaboration and partnerships necessary to define and achieve success for the CTSA Program are very different (e.g., community partnerships, collaboration with industry) and will require new leadership strategies. In 2011, the HHS OIG conducted a review of the administration of the CTSA Program in which OIG reviewers assessed files for the 38 co- operative agreements awarded from 2006 through 2008 (when the pro- gram was administered by the NCRR). This assessment found numerous lapses in program oversight. 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 regula- tions 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. Further, they found no evidence that project scientists assisted awardees in performing project activities; stopped activities that were not meeting performance require- ments; reviewed or approved the various stages of projects; approved the selection of key personnel, subawardees, or external contractors; con- ducted technical monitoring; or served on committees (OIG, 2011). The NCRR agreed that relevant information was not in the files in a meaning- ful way and presented its view that the NCRR worked with awardees “jointly in a partner role but did not assume direction, prime responsibil- ity, or a dominant role” (OIG, 2011, p. 27). Although more project moni- toring and aid may have taken place than the files reflect, there is no way to know. The OIG made several recommendations to remedy these shortcomings, including the following:  “NIH must ensure that staff document awardee accomplishments toward meeting project goals; reasons for not meeting project goals, if applicable; and plans for activities during the coming year.”  “NIH should ensure that staff document correspondence with awardees as they act to obtain delinquent progress reports and fi- nancial status reports.”  “At a minimum, staff must clearly list the Project Scientists in- volved and include the annual summary of involvement within the award files” (OIG, 2011, pp. ii–iii).

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LEADERSHIP 57 In considering the next steps for the CTSA Program and the recom- mendations that are made in this report, the IOM committee believes that NCATS should learn from previous experiences and lessons and take a more active role in the direction and oversight of the CTSA Program. The goal would be to ensure the highest achievable performance of indi- vidual CTSAs and to provide stronger guidance toward the development of a national network of institutions engaged in accelerating clinical and translational science. As the program’s newly designated home, NCATS has the opportunity, mission, and purpose to provide leadership for CTSA 2.0 and subsequent program phases. In addition to setting program direction through a revised mission and strategic goals for the CTSA Program (described in the following section), more active NCATS leadership will require that it take on sig- nificant responsibilities in promoting collaborations, conducting evalua- tions of progress, and ensuring that the program leverages the innovations provided by each of the individual CTSAs and their re- searchers, 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. For example, imposing a top-down generated research agenda or priorities that do not meet the needs of local researchers, health care providers, and communities would conflict with the original intent and spirit of the program. In addition, an overly directive approach to leader- ship could dampen creativity, ingenuity, and collaboration among the on-the-ground researchers. More active, but appropriately balanced, leadership from NCATS, combined with the creative talents and leader- ship from the PIs, will be critical in moving the CTSA Program to a more systems- and network-based approach to clinical and translational research and ensuring that the program remains focused on the outcomes most relevant to its overarching mission. Given the size of the CTSA Program, appropriate feedback loops and checks and balances should be incorporated into the program’s govern- ance, particularly through the vice-chair and other PIs on the new steer- ing committee that is recommended below. These bidirectional communication and governance strategies will help achieve balanced and informed leadership and will ensure that the active engagement of the on- the-ground perspectives and expertise is maintained and promoted.

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58 THE CTSA PROGRAM AT NIH Defining the Mission and Goals of the CTSA Program When NCATS was created in December 2011, components of vari- ous NIH programs were moved into the new center. These components include the CTSA Program, the Office of Rare Diseases Research, a va- riety of programs and activities that are housed in the NCATS Office of the Director for re-engineering translational research,1 and the newly cre- ated Cures Acceleration Network (IOM, 2012; NCATS, 2013c). All of these diverse activities must work together in order to fulfill the NCATS mission. Maximizing the benefits of bringing these various elements to- gether within NCATS requires rethinking the missions and goals of the individual pieces. The need for greater alignment within and across HHS agencies and activities was a major theme of a 2009 IOM report, HHS in the 21st Century: Charting a New Course for a Healthier America, which concluded that better alignment and focus on performance were essential to meeting departmental and agency goals (IOM, 2009). Mission As the CTSA Program matures, it is important to revisit the missions of NCATS and the CTSA Program to ensure alignment and that the CTSA Program supports the mission of NCATS. This IOM committee was specifically asked for its assessment of the appropriateness of the CTSA Program’s mission and goals. Box 3-1 contains the current mis- sion statements of NIH, NCATS, and the CTSA Program. In considering the appropriateness of the CTSA mission, the committee heard both sup- port for preserving coverage of the full spectrum of clinical and transla- tional research from T0–T4 and concern about the feasibility of doing so, given the limited available resources (IOM, 2013a). Tension about the scope of mission and uncertainty about the adequacy of resources is also reflected in the input that NIH received, in response to a request for in- formation (RFI), regarding ways to improve the program (Mulligan, 2012; NCATS, 2012c). The IOM committee noted that the current mission of NCATS could be interpreted as being more narrowly focused on the development of diagnostics and therapeutics than on the more global mission of the 1 For example, the tissue chip for drug screening initiative, activities related to rescuing and repurposing drugs, and activities related to identifying and validating drug targets.

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LEADERSHIP 59 BOX 3-1 Aligning the Missions Current Mission Statements NIH Mission: to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce the burdens of illness and disability. NCATS Mission: to catalyze the generation of innovative methods and technolo- gies that will enhance the development, testing, and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions. CTSA Current Program Mission: seeks to strengthen the full spectrum of trans- lational research. Institutional CTSA awards are the centerpiece of the pro- gram, providing academic homes for translational sciences and supporting research resources needed by local and national research communities to improve the quality and efficiency of all phases of translational research. Insti- tutional CTSAs also support the training of clinical and translational scientists and the development of all disciplines needed for a robust workforce for trans- lational research. Proposed CTSA Program Mission Statement A Suggested Streamlined Mission: to improve the quality and efficiency of the full spectrum of clinical and translational research and to speed the develop- ment and use of new diagnostics, therapeutics, and preventive interventions. SOURCES: NCATS, 2013a,b; NIH, 2011. CTSA Program, which focuses on the full spectrum of clinical and trans- lational research including preventive interventions and translation into front-line clinical and community practice. 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. As indicated below, strategic goals should be separated from the mission, and both need to be clear and consistent. The most recent RFA refers to a slightly different mission than that shown in Box 3-1, stating that the program works toward “increased quality, efficiency, and de-

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60 THE CTSA PROGRAM AT NIH creased cost of all translational research within academic institutions and nationally” (NIH, 2012c). A revamping of the mission should strive for simplicity and should reflect the program’s overarching purpose. In working to update the mis- sion of the CTSA Program, the committee suggests that NCATS also consider whether revisions to its own mission statement would help achieve better alignment between the two missions, highlighting support for the full spectrum of clinical and translational research. The commit- tee’s suggested streamlined mission for the CTSA Program also is pro- vided in Box 3-1. Goals Although the difference between mission and goals may seem large- ly semantic, the lack of separately articulated, achievable goals—versus a broad mission—weakens the ability to measure overall progress and establish accountability. As the CTSA Program has grown and evolved, variations on the goals have been cited, which indicates the goals of the program have not been communicated consistently and may not be well understood. 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 trans- lational sciences that increase the quality, safety, efficiency and speed of clinical and translational research, particularly for NIH supported re- search” (NIH, 2012c). Most recently, the program’s website describes goals for the “next phase” of the CTSA Program:  “Building a better bridge between pre-clinical and clinical science;  Providing a foundation of shared resources that could reduce costs, delays and difficulties experienced in clinical research, in- cluding trials;  Developing partnerships for research to be better integrated across sites and into ongoing patient care; and  Strengthening strategies for engaging patient communities into the research process” (NCATS, 2013b).

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LEADERSHIP 61 The issue of CTSA goals is further complicated by the CTSA Con- sortium’s separate set of five strategic goals: 1. National clinical and translational research capability; 2. Training and career development of clinical and translational scientists; 3. Consortiumwide collaborations; 4. The health of our communities and the nation; and 5. T1 translational research (CTSA Central, 2013a). As noted in Chapter 1, these consortium-generated goals were devel- oped through a strategic planning process conducted by the PIs in 2008, with the fifth goal added in 2009 (Disis, 2012; Reis et al., 2010). The IOM committee believes that these goals are overly broad and cannot be easily measured. In addition, because innumerable confounding factors in the clinical and translational ecosystem influence progress in these areas (see Chapter 2), the direct impact of the CTSA Program cannot be assessed. As the various lists of goals have grown apart, it is not clear which set, if any, accurately reflects the current and most pressing chal- lenges facing the clinical and translational research ecosystem or the goals that NCATS has for CTSA 2.0. Clearly defined, measurable goals directly tied to the mission and work of the CTSA Program will help better align the 61 awardees to achieve the vision for a more integrated network and will provide a basis for evaluation, reporting, and accountability. Clearer communication re- garding the goals, as distinct from the mission, also would facilitate pro- gram management and increase understanding of the program among its stakeholders. Reshaping and Reconciling Mission and Goals for the Future NCATS needs to take a leadership role in shaping the CTSA Pro- gram’s future by engaging in a strategic planning process in collabora- tion with the CTSAs to revise the program’s mission and establish measurable goals. As noted, the work of the CTSA Program has numer- ous important audiences and touches people in many domains— researchers, educators, clinicians, health care providers, payers, policy makers, staff in other government departments and agencies (e.g., De- partment of Veterans Affairs, Agency for Healthcare Research and Qual- ity [AHRQ], Centers for Medicare & Medicaid Services, Patient-

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62 THE CTSA PROGRAM AT NIH Centered Outcomes Research Institute, and the other NIH institutes and centers), private industry, nonprofit funding agencies, and, ultimately most important, communities, patients, and families. All these groups have a vital interest in achieving a more efficient and rapid clinical and translational research enterprise (see, for example, IOM, 2011), and they should be asked for input during the strategic planning process. In the transition of the CTSA Program from NCRR to NCATS, the NIH sought internal and external advice through an 11-member NIH working group. This group was asked to “enumerate the roles and capa- bilities of the CTSAs that could support and enhance the mission of NCATS; identify CTSA needs and priorities; and propose processes for ensuring a smooth transition from the NCRR to NCATS” (Katz et al., 2011). The working group consulted widely with individuals involved in the program in developing its recommendations for a smooth integration. In addition, NIH issued an RFI for input from public stakeholders, NIH personnel, and CTSA PIs that generated 139 responses, mostly from CTSA institutions (Mulligan, 2012; NCATS, 2012c). Conducting such broad-based outreach (as well as using the input already collected as a departure point) 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 rap- idly, and recognition of new opportunities that NCATS would create, including greater visibility and closer, more transparent working rela- tionships with NIH institutes and centers (CTSA PIs, 2012). Whatever process is adopted should result in a compelling mission statement and a single set of strategic goals that  are clearly defined and measurable;  reflect the full range of clinical and translational research;  are targeted at overcoming specific, current research challenges and barriers;  encourage clear decision points (go/no-go decisions) that pro- mote a flexible and dynamically responsive program;  build on program successes and reinforce areas of progress (e.g., training and education, community engagement, child health);

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LEADERSHIP 63  are fully supported and consistently communicated by all those involved; and  can serve as the basis for developing a set of common metrics for evaluating the individual CTSAs and the program as a whole. All components of the CTSA Program—NCATS, CTSA consortium committees, the CTSA Coordinating Center, individual CTSAs, and the researchers whose work is supported through the program—should be focused on achieving these unified goals. This is essential in order to es- tablish accountability and assess progress, as outlined in HHS in the 21st Century (IOM, 2009). As the CTSA Program moves forward, these goals should be reviewed and updated periodically as progress is made, as the research ecosystem continues to evolve, and as population health needs change. STRUCTURE OF THE CTSA PROGRAM The CTSA Program has grown rapidly, from 12 sites in 2006 to 61 in 2012. From the program’s outset, the NIH and the individual CTSAs have recognized the value of collaboration and the need for a cross- institutional structure to advance the program’s efforts; this recognition was the beginning of the vision for a CTSA network. In the early stages of the program, the NIH charged CTSAs with developing a national con- sortium to promote and implement best practices, policies, and proce- dures (NIH, 2005). The first funding announcement stated that a National CTSA Consortium Steering Committee should be organized for PIs. In addition, as discussed in Chapter 1, it directed that subcommittees be formed to foster advances in the NIH-identified common themes (e.g., education, informatics, regulation) and that these committees meet annu- ally and have representation from each CTSA (NIH, 2005). In subsequent years, the CTSA Consortium developed largely as an unfunded grass-roots effort through the commitment and energy of PIs and researchers. 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. In total, these committees involve more than 2,000 people (CTSA Central, 2013d; Reis et al., 2010) (see Chapter 1).

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94 THE CTSA PROGRAM AT NIH  a clear understanding of whether progress is being made; and  corrective action as needed (IOM, 2009). The current clinical and translational science ecosystem presents many challenges in identifying and testing therapeutic and preventive interventions for safety and efficacy and moving them into clinical and community settings. The IOM committee believes that the CTSA Pro- gram has a major role to play in overcoming those challenges and facili- tating and accelerating clinical and translational research. Meeting these tasks will necessitate a CTSA Program that meets the accountability standards outlined above, is nimble enough to be action oriented, has the ability to focus the disparate energies and talents of many institutions and individuals, and is able forge the partnerships and collaborations needed to move forward in a complex research ecosystem. The committee urges NCATS to take a more active role in the direc- tion of the CTSA Program and to build on its current strengths by setting clear and measurable goals, streamlining the program structure, estab- lishing accountability and transparency, communicating its value, and instilling strong evaluation expectations. Recommendation 1: Strengthen NCATS Leadership of the CTSA Program NCATS should strengthen its leadership of the CTSA Pro- gram 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 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;

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LEADERSHIP 95  establish an innovations fund through a set-aside mecha- nism 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 government agencies, private foun- dations, community advocates and organizations);  evaluate the program as a whole to identify gaps, weak- nesses, and opportunities and create mechanisms to ad- dress them; and  distill and widely disseminate best practices and lessons learned by the CTSA Program and work to communicate its value and accomplishments and seek opportunities for further efforts and collaborations. 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. In doing so, CTSAs should  drive innovation and collaboration in methodologies, processes, tools, and resources across the spectrum of clinical and translational research;  emphasize interdisciplinary team-based approaches in training, education, and research;

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96 THE CTSA PROGRAM AT NIH  involve patients, family members, health care providers, and other community partners in all phases of the work of the CTSA;  strengthen collaborations across the schools and disci- plines in their home institutions;  build partnerships with industry, other research net- works, community groups, and other stakeholders; and  communicate the resources available through the CTSA Program. Recommendation 4: Formalize and Standardize Evaluation Processes for Individual CTSAs and the CTSA Program NCATS should formalize and standardize its evaluation pro- cesses for individual CTSAs and the CTSA Program. 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). 2012. Practice-Based Research Networks. http://pbrn.ahrq.gov (accessed March 11, 2013). Alexander, A., J. A. Hogle, C. Kane, H. M. Parsons, and L. Phelps. 2013. The Clinical and Translational Science Award National Evaluators Survey: Where are we now? Submitted to the IOM Committee by D. Rubio on March 28. Available by request through the National Academies’ Public Access Records Office. Austin, C. P. 2013. National Center for Advancing Translational Sciences: Catalyzing translational innovation. 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/ http://www.iom.edu/~/media/Files/Activity%20Files/Research/CTSAReview/ 2013-JAN-24/Chris%20Austin.pdf (accessed February 13, 2013). Briggs, J. 2012. Evaluation of the CTSA Program. Remarks presented at Meeting 2: IOM Committee to Review the CTSA Program at NCATS, Washington, DC, December 12. Briggs, J., and C. P. Austin. 2012. NCATS and the evolution of the Clinical and Translational Science Award (CTSA) Program. PowerPoint presented at

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98 THE CTSA PROGRAM AT NIH Stenzelg, G. Schaeferg, W. Horningerg, J. Bekticg, A. M. Chinnaiyanh, S. Goldenbergi, J. Siddiquih, M. M. Regank, M. Kearneyl, T. D. Soongb, D. S. Rickmana, O. Elementob, J. T. Weij, D. S. Scherri, M. A. Sandal, G. Bartschg, C. Leed, H. Klockerg, and M. A. Rubin. 2012. Identification of functionally active, low frequency copy number variants at 15q21.3 and 12q21.31 associated with prostate cancer risk. Proceedings of the National Academy of Sciences of the United States of America 109(17):6686–6691. Disis, N. 2012. CTSA strategic goal 5: Advancing T1 translational research. 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/6-Disis%20IOM_CTSA_StrategicGoal5_Disis_10%2029 %2012.pdf (accessed March 26, 2013). Fagnan, L. J., M. Davis, R. A. Deyo, J. J. Werner, and K. C. Stange. 2010. Linking Practice-Based Research Networks and Clinical and Translational Science Awards: New opportunities for community engagement by academic health centers. Academic Medicine 85(3):476–483. Felt, U., B. Wynne, M. Callon, M. E. Goncalves, S. Jasanoff, M. Jepsen, P.-B. Joly, Z. Konopasek, S. May, C. Neubauer, A. Rip, K. Siune, A. Stirling, and M. Tallacchini. 2007. Taking European knowledge society seriously: Report of the expert group on science and governance to the science, economy and society directorate, Directorate-General for Research, European Commission. Luxembourg: Office for Official Publications of the European Communities. http://ec.europa.eu/research/science-society/document_library/ pdf_06/european-knowledge-society_en.pdf (accessed March 26, 2013). Fine, J. 2012. Translation of basic science to human studies: Advancing T1 and T2 research. 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-12/1-4%20Jacqueline%20Fine.pdf (accessed March 26, 2013). Frechtling, J., K. Raue, J. Michie, A. Miyaoka, and M. Spiegelman. 2012. The CTSA national evaluation phase 1 final report. Rockville, MD: Westat. https://www.ctsacentral.org/sites/default/files/files/CTSANationalEval_Final Report_20120416.pdf (accessed April 1, 2013). Germino, G. G. 2012. Opportunities for NIDDK-CTSA cooperation. 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-20/NIH%20presentations/ 4-%20Germino%20CTSA%20IOM%20NIDDK.pdf (accessed February 21, 2013). Harvard College. 2012. About eagle-i. https://www.eagle-i.net/about (accessed March 1, 2013). Heatwole, C., R. Bode, N. Johnson, C. Quinn, W. Martens, M. P. McDermott, N. Rothrock, C. Thornton, B. Vickrey, D. Victorson, and R. Moxley III.

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100 THE CTSA PROGRAM AT NIH Lee, L. S., S. N. Pusek, W. T. McCormack, D. L. Helitzer, C. A. Martina, A. M. Dozier, J. S. Ahluwalia, L. S. Schwartz, L. M. McManus, B. D. Reynolds, E. N. Haynes, and D. M. Rubio. 2012. Clinical and translational scientist career success: Metrics for evaluation. Clinical and Translational Science 5(5):400–407. McCormack, F. X., Y. Inoue, J. Moss, L. G. Singer, C. Strange, K. Nakata, A. F. Barker, J. T. Chapman, M. L. Brantly, J. M. Stocks, K. K. Brown, J. P. Lynch, III, H. J. Goldberg, L. R. Young, B. W. Kinder, G. P. Downey, E. J. Sullivan, T. V. Colby, R. T. McKay, M. M. Cohen, L. Korbee, A. M. Taveira-DaSilva, H.-S. Lee, J. P. Krischer, and B. C. Trapnell. 2011. Efficacy and safety of sirolimus in lymphangioleiomyomatosis. New England Journal of Medicine 364(17):1595–1606. Michaud, M. 2012. In muscular dystrophy, what matters to patients and doctors can differ. http://www.urmc.rochester.edu/news/story/index.cfm?id=3567 (accessed March 1, 2013). Miyaoka, A., M. Spiegelman, K. Raue, and J. Frechtling. 2011. Findings from the CTSA National Evaluation Education and Training Study. Rockville, MD: Westat. https://ctsacentral.org/sites/default/files/documents/Education TrainingReport_20111228.pdf (accessed April 1, 2013). Mulligan, L. 2012. Compliation of Request for Information responses from May 5, 2012. Submitted to the IOM Committee on September 17. Available by request through the National Academies’ Public Access Records Office. NCATS (National Center for Advancing Translational Sciences). 2012a. Clinical and Translational Science Awards factsheet. http://www.ncats.nih. gov/files/ctsa-factsheet.pdf (accessed March 26, 2013). ———. 2012b. FAQ about CTSA RFA-TR-12-006. http://www.ncats.nih.gov/ research/cts/ctsa/funding/faq/faq.html (accessed March 22, 2013). ———. 2012c. Request for information: Enhancing the Clinical and Translational Science Awards Program. http://www.ncats.nih.gov/files/report-ctsa-rfi.pdf (accessed April 8, 2013). ———. 2013a. About NCATS. http://www.ncats.nih.gov/about/about.html (accessed March 26, 2013). ———. 2013b. About the CTSA Program. http://www.ncats.nih.gov/research/ cts/ctsa/about/about.html (accessed April 8, 2013). ———. 2013c. NCATS: Program index. http://www.ncats.nih.gov/about/ program-index/program-index.html (accessed March 26, 2013). ———. 2013d. News and events: Feature stories. http://www.ncats.nih.gov/ news-and-events/features/features.html (accessed March 26, 2013). NCRR (National Center for Research Resources). 2009. Progress report 2006– 2008 Clinical and Translational Science Awards: Advancing scientific discoveries nationwide to improve health. http://www.ncats.nih.gov/files/ 2008_ctsa_progress_report.pdf (accessed March 26, 2013). NIAID (National Institute of Allergy and Infectious Diseases). 2012. Not-for- profit partnership with Eli Lilly and Company for TB early phase drug

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102 THE CTSA PROGRAM AT NIH Prescott, B. 2012. Researchers uncover important clues to a dangerous complication of pregnancy. http://www.bidmc.org/News/InResearch/2012/ May/Arany_PPCM.aspx (accessed March 1, 2013). Pulley, J. 2013. CTSA essays and worksheets. Submitted to the NIH CTSA/NCATS Integration Working Group, July 2011. Submitted to the IOM Committee on January 7. Available by request through the National Academies’ Public Access Records Office. Purdy, M. C. 2012. Stroke patients benefit from carmaker’s efficiency. http://news.wustl.edu/news/Pages/24442.aspx (accessed March 1, 2013). Raue, K., A. Miyaoka, M. Spiegelman, and J. Frechtling. 2011. Findings from the CTSA national evaluation utilization study. Rockville, MD: Westat. https://ctsacentral.org/sites/default/files/documents/EducationTrainingReport_ 20111228.pdf (accessed April 1, 2013). Reed, J. C., E. L. White, J. Aube, C. Lindsley, M. Li, L. Sklar, and S. Schreiber. 2012. The NIH’s role in accelerating translational sciences. Nature Biotechnology 30(1):16–19. Reis, S. E., L. Berglund, G. R. Bernard, R. M. Califf, G. A. FitzGerald, and P. C. Johnson. 2010. Reengineering the national clinical and translational research enterprise: The strategic plan of the National Clinical and Translational Science Awards Consortium. Academic Medicine 85(3):463– 469. Rosenblum, D., and B. Alving. 2011. The role of the Clinical and Translational Science Awards program in improving the quality and efficiency of clinical research. Chest 140(3):764–767. Rubio, D. 2013. Evaluation Key Function Committee’s outline of next steps for common metrics. Submitted to the IOM Committee on March 28. Available by request through the National Academies’ Public Access Records Office. Rubio, D. M., D. J. del Junco, R. Bhore, C. J. Lindsell, R. A. Oster, K. M. Wittkowski, L. J.Welty, Y.-J. Lih, and D. DeMetsi. 2011a. Evaluation metrics for biostatistical and epidemiological collaborations. Statistics in Medicine 30(23):2767–2777. Rubio, D. M., B. A. Primack, G. E. Switzer, C. L. Bryce, D. L. Seltzer, and W. N. Kapoor. 2011b. A comprehensive career-success model for physician-scientists. Academic Medicine 86(12):1571–1576. Rubio, D. M., M. Sufian, and W. M. Trochim. 2012. Strategies for a national evaluation of the Clinical and Translational Science Awards. Clinical and Translational Science 5(2):138–139. Shurin, S. B. 2012. CTSA V. 2.0 perspective from the NLHBI. 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/NIH%20presentations/ 2-Shurin-IOM%20CTSA%202012%2010%2018%20rev%20JW.pdf (accessed February 21, 2013).

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