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NIH Extramural Center Programs: Criteria for Initiation and Evaluation F Summary of Selected Center Program Evaluations Previously Conducted by NIH The following summary of prior center program evaluations by the National Institutes of Health (NIH) was produced by the Institute of Medicine (IOM) staff based on publicly available copies of the referenced reports. NATIONAL CANCER INSTITUTE The National Cancer Institute (NCI) has supported Cancer Research Centers since at least 1961, although the Cancer Centers Program was formally conceived and established as a result of the National Cancer Act of 1971. That program has been the subject of at least three formal evaluations, which are summarized in the following three sections. Institute of Medicine Report, “A Stronger Cancer Centers Program: Report of a Study” (1989) In 1988 the Senate Appropriations Committee report accompanying the 1989 appropriations bill requested that NIH contract with IOM for a study on “the present state of the Cancer Centers Program and its funding and organizational needs required to fulfill the role established for cancer centers in the 1971 National Cancer Act.” The Senate committee had heard increasing complaints about the flat growth in the amount of NCI funds going to cancer centers because NCI leadership apparently wanted to deemphasize the role of centers relative to other mechanisms in the national
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NIH Extramural Center Programs: Criteria for Initiation and Evaluation cancer program. The IOM committee, a mixture of scientists with and without cancer center affiliations, conceded that it lacked hard evidence of the effects of cancer centers on the nature or quality of the research conducted in them and as a result relied on its collective judgment, based on expertise in biomedical research and study of existing information on cancer centers and their achievements (IOM, 1989). The report noted that scientists at the 59 centers with NCI core grants received nearly half the competitive research project grants awarded by NCI and substantial amounts of peer-reviewed funding from other NIH institutes, the National Science Foundation, and other research sponsors, and as a result, they had been involved in many of the important advances in cancer research over the preceding 20 years. They also noted that the centers were the sites for more than half the research traineeships funded by NCI and they participated extensively in the cooperative oncology groups that conducted NCI-supported clinical trials and other aspects of NCI’s national cancer program. They concluded that, as a group, the centers were a valuable resource for NCI because of their interdisciplinary focus and their ability to translate research discoveries into better methods of prevention, early detection, diagnosis, and treatment. The report’s first recommendation was that the NCI director halt the slow erosion of center funding that had characterized the previous eight years. A second recommendation called for NCI to develop a systematic program plan that would ensure adequate resources, coordination with related programs, and effective scientific oversight. The committee commented in passing that, taken as a whole, the centers were involved in every aspect of the national cancer research program, but that additional incentives should be provided to encourage individual centers to broaden their research agendas. They also pointed out the disparity between NCI’s support of cancer centers as research institutions and the broader role of centers intended by Congress and expected by the public. Despite the National Cancer Act of 1971’s mandate for comprehensive centers that conducted not only research and research training but demonstrations of better models of care delivery, education of health care providers, public information, and community outreach programs, the cancer center core grants focused solely on support of research, and grant funds could not be used for those other purposes (IOM, 1989). “Report of the National Cancer Institute Cancer Centers Program Review Group” (1996) The authors of this report to the NCI director reviewed data on the history, budget, and operations of the Cancer Centers Program; heard testimony from a variety of NCI personnel and cancer center directors; and
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NIH Extramural Center Programs: Criteria for Initiation and Evaluation solicited and received comments in writing from the cancer center community (NCI, 1996). They began with the assumption that “cancer centers already had demonstrated that complex research strategies are feasible, and are poised to undertake novel multidisciplinary approaches to important new research opportunities” and envisioned the review as an opportunity to recommend improvements. They recommended that only two varieties of cancer centers be recognized (comprehensive cancer research center and cancer research center) rather than three (basic, clinical, and comprehensive). This was, in part, recognition that many basic centers were also involved in translational research and that most clinical centers included a strong basic research element. Equally important to the authors was inserting “research” into the title of the centers (i.e., cancer research centers), reflecting their view that research should remain the central emphasis of these centers and also the fact that core grants did not fund many of the other activities Congress and the public expected. The report took “comprehensive” to mean that the centers should perform basic, clinical, and population-based research, and it recommended that NCI provide a different mechanism for funding the education and training of biomedical researchers and health care professionals, public information services, and community service and outreach. Consistent with this view, it further recommended that centers be reviewed primarily for the quality of science and the value added by the Cancer Center core grants to the advancement of excellence in the areas of cancer research supported by NCI. The authors argued that, although a large part of a center grant supports infrastructure, these facilities should not be the primary basis of review. Rather, the cancer research that they facilitate should be the primary basis for evaluation. To that end they suggested a more stringent separation of review and program administration and more frequent use of center directors and senior faculty as reviewers. Among a number of suggestions for better use of available funds was a proposal that funding for the lowest ranked centers in each renewal cycle be phased out over a three-year period. “Advancing Translational Cancer Research: A Vision of the Cancer Center and SPORE Programs of the Future” (2003) This February 2003 report by a subcommittee of the National Cancer Advisory Board was the result of a new institute director’s request for advice on how the P30 (core) and P50 (specialized research) center awards might best be used to increase discovery and maximize translation into practice during he period of modest budget growth expected to follow the five-year budget doubling effort of FY1999 to FY2003 (NCAB, 2003). About half the working group’s members were directors or senior staff at cancer centers, and a major source of information for the group was a
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NIH Extramural Center Programs: Criteria for Initiation and Evaluation survey it conducted of P30 cancer center directors. Among other data, the survey reported the total research and operating budgets of the centers and their sources of funding. Total non-P30 research support to investigators at these centers was in excess of $1.5 billion annually, more than 10 times the amount of the P30 awards themselves. Additional income from the centers’ home institution, gifts, and state and local governments totaled more than $660 million. The centers also reported having seen more than 1,100,000 newly diagnosed cancer patients over the previous five years and having enrolled nearly 30,000 patients in clinical trials in the previous year. The centers’ training activities encompassed more than 9,000 basic scientists, 3,800 clinical fellows, and 3,000 oncology nurses in the previous five years. Last, the survey revealed that more than 2,500 patents had been issued to centers or center-affiliated scientists in the past five years. NCI’s P50 grants are called Specialized Programs of Research Excellence (SPOREs). They focus on organ-site-specific cancers (breast, prostate, lung, etc.) and fund not just infrastructure but specific research projects. The program began in 1992 and included 44 awards covering 11 organ sites by FY2003. The working group pointed out that this rate of growth is unsustainable, and it was also concerned about possible duplication of activities already funded by P30 grants, particularly because 41 of the 44 P50 awards were to institutions with P30 core grants. The report recommended slowing the growth of SPOREs, increasing the budget of the Cancer Center Program, and mandating that SPOREs located at a cancer center should function as a component of that center. Other suggestions for NCI included encouraging and funding centers to develop and test novel methods for disseminating new knowledge, allowing P30 grant holders to provide partial salary support to physicians with major clinical responsibilities, and developing improved and quantifiable metrics for both making individual awards and for evaluating the P30 and P50 programs. NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL DISEASES In 1997 the Director of the National Institute of Arthritis and Musculoskeletal Diseases (NIAMS) presented the NIAMS National Advisory Council with a plan for external review of the institute’s center program. After approval by the Council, he appointed a 13-member working group comprised of investigators affiliated with NIAMS centers and investigators without such connections. The group developed a clear definition of issues, which were then addressed by a second working group, similar in composition to the first. Working Group II reviewed extensive background materials provided by the NIAMS staff and was briefed by representatives of other institutes on their respective center programs. A questionnaire ad-
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NIH Extramural Center Programs: Criteria for Initiation and Evaluation dressing many of the issues raised by Working Group I was sent to all NIAMS center directors (N=30) and all non-center-affiliated investigators receiving more than $5 million per year in NIAMS funding (N=26). The response rate was about 50 percent for each group. The report’s conclusions were as follows (NIAMS, 1997): Where centers had worked most effectively, it was in support of synergistic interactions between investigators and as a mechanism for support of research infrastructure, clinical research and education, epidemiology, and health services research (EEHSR). The P60 Multipurpose Arthritis and Musculoskeletal Disease Centers (MAMDCs) had provided economies of scale and support for pilot studies and for development of new investigators. They had made important contributions to development of the field of health services research and provided an infrastructure for communication and translation of research results to the clinical practice community. Limitations of the MAMDC Program included a focus restricted to arthritis and musculoskeletal research and an artificial requirement for combining basic science research and EEHSR components. In some cases, P50 Specialized Centers of Research (SCORs) had successfully provided for focused research into the problems associated with a particular disease. Often, however, this focus was limiting the scope of programs within institutions more than might be desirable, with resulting unevenness of quality among components of the SCORs. The P30 Skin Disease Research Centers were having a positive and important impact in the provision of essential infrastructure support for outstanding academic programs in dermatology, and the Working Group recommended that the P30 mechanism be expanded to other NIAMS program areas. No body of knowledge uniquely requires the centers mechanism for support. The best approach to research support regardless of subject remains the R01 research project grant. Nevertheless, it is important that the institute find other mechanisms for support of any topics crucial to the mission of NIAMS that do not attract competitive R01 applications. The Working Group did not believe there were critical masses of outstanding investigators necessary to justify support of MAMDCs as currently configured at more than a few institutions. The restriction of the SCOR Program to research in certain disease categories (e.g., rheumatology) was resulting in an undesirable narrowness of focus that might be obviated by centers with a broader mandate for the study of pathogenetic mechanisms. The Working Group concluded that the centers should be configured to promote interaction between NIAMS investigators. There should
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NIH Extramural Center Programs: Criteria for Initiation and Evaluation be sufficient flexibility, including availability of several funding mechanisms (P30, P50, and P60), so that various configurations of investigators could exploit optimally their areas of expertise. Comprehensive centers of excellence existed in a small number of institutions, and continued support of such centers, utilizing the P60 mechanism, was recommended. Development and feasibility funds had generally proven effective in leveraging support into full project funding. Additionally, the EEHSR component of the MAMDCs appeared to have attracted significant non-NIAMS support into this area of research. Centers were proving particularly valuable in building and maintaining the intellectual and physical resources that serve as infrastructure for successful programs. Moreover, to the extent that centers provide an important measure of research stability and continuity, they were a valuable resource for research across the spectrum of NIAMS-related diseases. Every dollar so invested was not available to other funding mechanisms, particularly the R01 individual research grants program, and the Working Group believed that arthritis research was disproportionately supported through a center mechanism. The Working Group suggested that competing applications be grouped for review, so that relative strengths and weaknesses of applications could be directly compared. There was little enthusiasm for triaging center applications, because applications from weaker centers derive considerable benefit from thorough review and discussion of their relative strengths and weaknesses. Planning grants were not generally regarded as cost-effective or necessary, except perhaps modest planning grants for developing multiinstitutional consortia, especially for clinical research studies. Use of the R03 funding mechanism to permit support of pilot studies by investigators in institutions or programs lacking centers was recommended for consideration. The Working Group concluded its review by affirming the importance of the various centers programs to the mission of NIAMS. It urged continued support, albeit at a more limited level, of a variety of funding mechanisms for centers, across the breadth of NIAMS. NATIONAL INSTITUTE OF DEAFNESS AND OTHER COMMUNICATION DISORDERS The Work Group on Single and Multiple Project Grants was formed to provide advice to the national advisory council and director of the National Institute of Deafness and Communication Disorders (NIDCD). Its charge was to consider the benefits and drawbacks of single project (R01) grants in
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NIH Extramural Center Programs: Criteria for Initiation and Evaluation contrast to multiple project (P01, P50, P60) grants and to explore the value of adding core grants (P30) to NIDCD’s portfolio of extramural research mechanisms (NIDCD, 1998). Suggestions and guidance from the scientific community were requested. The NIDCD placed the charge to the Work Group, along with a series of specific questions about multiple project grants, especially centers, on its Home Page. The American Academy of Otolaryngology-Head and Neck Surgery, Association of Chemoreception Sciences, Association for Research in Otolaryngology, and American Speech-Language-Hearing Association communicated electronically with their members to provide input. In addition, the principal investigators of the 39 multiple project grants active in 1997 were solicited individually for their views. The report recommended that NIDCD adopt a limited version of the multiple project center grant (P50) based on the following criteria: Projects must be interdependent (materials, results, data, or methodologies are shared among the projects), interrelated (each project must have goals and objectives that focus on the common theme), and multidisciplinary (subproject leaders and/or projects representing different scientific backgrounds, training, and expertise). The feasibility of the research proposed on any project would be significantly diminished if that project were submitted as a traditional individual research project (R01) application. The report suggested that prospective applicants be asked to explain in a letter of intent exactly how their proposed applications meet these criteria. The Work Group also recommended that NIDCD initiate a core grant (P30) program to complement the P50 multiple project center grants program. On the other hand, its analysis of the five existing P60 multipurpose centers mandated by law led them to recommend that an alternative funding mechanism for the continuing education and information dissemination activities supported by the P60 mechanism be explored. Finally, they recommended that NIDCD be included as a participant in the NIH Interactive Research Project Grant (IRPG) Program. The IRPG Program provides for the coordinated submission of two or more applications for related traditional research project grants (R01) on related topics, with a formalized agreement to collaborate in specific ways to enhance the achievement of the goals on all projects. This would require that NIDCD develop a rapid review capability to determine the additional resources, if any, that would be required to optimize performance for those collaborating grantees, assuming that both are rated highly by their respective study sections at the Center for Scientific Review.
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NIH Extramural Center Programs: Criteria for Initiation and Evaluation OFFICE OF AIDS RESEARCH The Centers for AIDS Research (CFAR) program was established in 1988 by the Office of AIDS Research (OAR) Advisory Council to provide an environment for multidisciplinary collaborations by basic, clinical, epidemiological, and behavioral scientists. In 1995 the CFAR program was evaluated as part of a comprehensive review by the NIH AIDS Research Program Evaluation Working Group, known as the “Levine Report” (OAR, 1996).1 The Levine Report recommended strengthening CFARs to promote multidisciplinary AIDS research by increasing the funding for the program. This resulted in the doubling of the CFAR program and the participation of five additional institutes beyond the National Institute of Allergy and Infectious Diseases. In 1999, in view of the substantial changes that had been introduced, OAR decided to conduct a review that would focus exclusively on the structure of the CFAR program, to assess its successes and identify needed course corrections. A focus group of external consultants was convened to conduct such a review. The focus group was notable for its inclusion not only of scientists representing a broad range of disciplines and experience with research centers (none from CFARs), but also of scientists from Europe and Africa and a nonscientist member of the AIDS Vaccine Advocacy Coalition. They were joined at the group’s single face-to-face meeting by discussants who were engaged in CFAR-related research activities, as well as two CFAR directors. The ensuing “Report of the Focus Group to Review the Centers for AIDS Research (CFAR) Program” concluded that the CFAR program had been successful in fostering collaboration between existing research programs related to HIV and AIDS, had promoted multidisciplinary approaches to AIDS/HIV-related problems, and had provided added value beyond the sum of the individual parts (OAR, 1999). It cited examples where CFARs had successfully leveraged developmental funds to increase investigator-initiated R01 funding among junior faculty members; enhanced faculty recruitment; refocused existing faculty not currently engaged in AIDS research on HIV-related issues; and generated significant local institutional support for the center program. It recommended that the size and overall proportion of the NIH AIDS budget devoted to CFARs should be increased (but in a stepwise manner over three years to minimize the impact on funding for R01s). It also emphasized that sustained growth of the program, particularly in terms of a percentage of the overall budget, should be contingent on improved outcome measures that can show added value of the CFAR program beyond funding of independent awards. 1 The report was named after its chair, Arnold J. Levine, of Princeton University.
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NIH Extramural Center Programs: Criteria for Initiation and Evaluation The authors conceded that much of the value of a center program is intangible, qualitative, and anecdotal, but felt that more effort should be placed on objectifying the measurement of added value. Examples of possible measures of the impact of a center program included lists of interdisciplinary manuscripts; new grant support for faculty previously funded by pilot projects; evidence of enhancement of existing programs; the use of core facilities; the number of protocols started within a single institution; other evidence of translational work, such as applications for patents; and evidence of leveraging pilot studies into R01 funding or CFAR support into institutional support. The group also felt that more emphasis should be placed on promoting the development of future investigators, either through support and mentoring of junior faculty or attraction of established investigators into the field of HIV-related research. NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT The mission of the Demographic and Behavioral Sciences Branch (DBSB) of the National Institute of Child Health and Human Development (NICHD) is to foster research on the processes that determine population size, growth, composition and distribution, and on the determinants and consequences of those processes. DBSB maintains a network of Population Research Centers that provide core support (P30 awards) for research projects relevant to the DBSB mission at leading universities and research centers throughout the United States. The Population Research Centers Program had begun in the early 1970s, and in 1999 DBSB staff decided that a review of the program was in order. The review was not intended to assess the merit or productivity of specific centers, but to review the way in which NICHD had shaped the program over the last few decades and to explore strategies for the future. DBSB recruited six scientific experts to assist in conducting the evaluation, two of whom were affiliated with institutions receiving NICHD center support. The scientists reviewed data summarizing the fiscal and scientific scope of the Centers Program as it existed currently; interviewed key constituencies concerning the existing and potential functions of infrastructure support in the population sciences; reviewed comments received by the branch regarding the Centers Program; and reviewed information on alternative models of structuring infrastructure support programs in the behavioral and social sciences. A request for comments was posted on the branch’s webpage, which resulted in 77 replies. The consulting scientists spoke with colleagues in the field, and NIH provided historical data about the grant submissions and funding histories of both NICHD-funded and nonfunded population centers. Based on these data, the consultants assisted the branch
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NIH Extramural Center Programs: Criteria for Initiation and Evaluation in developing recommendations for adapting and changing the program to meet future scientific needs. The “Report of the Demographic and Behavioral Sciences Branch Population Centers Review” recommended that NICHD continue to support infrastructure for population research at about the same level as present, allowing for inflation (NICHD, 1999). It cited data showing that institutions with NICHD-funded centers submitted more applications to NICHD and had higher success rates than non-NICHD-funded centers; NICHD-funded centers provided support for an average of 32 individual research projects at each site; and centers were highly successful in leveraging substantial additional funds for both research and infrastructure (93 percent of center funds came from sources other than the P30 grant). The authors nevertheless called for increased flexibility in the way funds could be expended at the center level. For example, they called for seed money programs to quickly provide money for pilot projects, giving centers permission to support noncenter scientists doing relevant population research; and a stronger link to graduate training. They came out strongly against “sunset” rules, instead offering several suggestions to improve competition in the application/renewal process. A unique feature of the report was a concluding section in which staff outlined plans for implementing the report’s suggested changes. In short, staff proposed that center core grants be phased out in favor of R24 research resource-related grants. The R24 has many of the characteristics of the traditional center grants, e.g., support of infrastructure to support a portfolio of research in an institution. However, according to staff, the R24 would provide more flexibility than the P30 grant, enabling centers to pursue scientific opportunities at the boundary between traditional population research and allied fields and to facilitate partnerships among center personnel and collaborators in other institutions and between the center and complementary institutions around the world. Eligibility for an R24 infrastructure grant depends on the existence of a center or other identifiable administrative unit at the applicant institution, but applicants would be able to request support for: Core services and facilities similar to those found in traditional P30 grants; Developmental infrastructure (e.g., seed grants, faculty development, technological specialists, and planning workshops); Translational cores to provide support for public-use access to large-scale data collection projects housed in the center, and/or outreach efforts to elucidate the clinical or public policy implications of work ongoing within the center;
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NIH Extramural Center Programs: Criteria for Initiation and Evaluation Cooperative research partnerships with colleagues in other institutions and joint ventures with other institutions to provide research services to center researchers; and Research projects similar to R01 projects. NATIONAL HEART, LUNG, AND BLOOD INSTITUTE The National Heart, Lung, and Blood Institute (NHLBI) initiated SCOR programs in 1971 to encourage research to translate basic science findings to the clinic. SCOR grants require both basic and clinical research projects focused on diseases and clinical problems relevant to the mission of the institute. The interactions between the basic and clinical projects are intended to enhance transfer of fundamental research findings to the clinical setting and to help focus fundamental research investigations on issues of major clinical importance. By FY2001 NHLBI had 14 different SCOR programs, each supporting several centers. In 1993 NHLBI established a process of inviting extramural experts to conduct a formal evaluation of each SCOR program early in its second five-year funding period to advise the institute on continued relevance and future directions. Unless “extraordinarily important reasons” to continue a specific SCOR program are identified, a sunset provision limits the program to 10 years of continuous funding (Lenfant, 2002). Two reviews in late 2000 and early 2001 noted excellent scientific productivity in the two SCOR programs they evaluated, but they both noted that direct contributions to clinical care were not clear and there was little evidence of productive collaborations between basic and clinical investigators. These comments raised concerns that the SCOR mechanism may not be fulfilling its intended translational research function, and thus it may not be distinguishable in practice from the P01 program project grant mechanism. In response to these findings, the NHLBI director appointed a SCOR “reinvention committee” of extramural program staff, which was charged with evaluating the strengths and weaknesses of the SCOR mechanism and recommending ways to enhance the clinical focus and utility in SCOR programs. The “Report from the Committee to Redefine the Specialized Centers of Research Programs” was completed in September 2001 (NHLBI, 2001). In it, the committee agreed unanimously that the SCOR program offers a unique mechanism for producing collaboration between basic and clinical researchers that would otherwise be unlikely to occur. Furthermore, the SCOR program provides an excellent tool to further NHLBI’s goal of translating bench findings to the bedside, and SCOR centers are a natural venue for training both basic scientists and clinicians in clinical research. They also agreed that clinically relevant questions should be the central
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NIH Extramural Center Programs: Criteria for Initiation and Evaluation theme in the next iteration of SCOR awards, despite the fact that the clinical questions posed in past SCOR programs have not been as well developed as the basic science research. The report’s recommendations focus on how to change that. First was a recommendation to begin with a new title that emphasizes the centrality of clinical research—Specialized Centers of Clinically Oriented Research (SCCOR). The committee recommended that the number of clinical projects in each SCCOR must be greater than or equal to the number of basic science projects (only a single clinical project was required in SCORs regardless of the number of basic projects). The committee recognized that expanded clinical research would require more and different types of infrastructure support and made several suggestions along those lines. They recommended that the Request for Applications (RFA) stipulate that the resources represented by cores and any materials developed in them (e.g., biological specimens) should be shared widely within the SCCOR program (i.e., with grantees at other institutions). They also suggested that each SCCOR program carefully consider the possible benefits of supporting a clinical core to serve all grantees in the SCCOR, in which case a single clinical core would be chosen from among all grantees. The committee made several suggestions designed to provide more weight to clinical research in the review of individual applications, recommended that the budget cap for individual awards be raised even if it meant fewer awards, and supported the five-year award length and the outside review and sunset provisions of the SCOR programs. NATIONAL INSTITUTE ON AGING In 1984 Congress directed the National Institute on Aging (NIA) to foster further research on Alzheimer’s disease, and NIA responded by initiating the Alzheimer’s Disease Center (ADC) program, which now includes 17 Alzheimer’s Disease Research Centers (ADRCs) and 12 Alzheimer’s Disease Core Centers (ADCCs). In January 2003 NIA issued an RFA inviting applications for support of ADRCs.2 The RFA was issued in anticipation of funding nine new and/or competing renewal ADRC grants in FY2004, but in preparing the RFA the NIA sought input from scientists both inside and outside of the existing centers on what had worked well during the first 20 years of the ADCC program and what had not, and on whether the configuration of the centers program is the best one for the foreseeable future. Suggestions for changes that would improve center op- 2 RFA-AG-03-006.
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NIH Extramural Center Programs: Criteria for Initiation and Evaluation erations were discussed in a meeting of all current center directors and NIA staff held in May 2001. A second, smaller meeting garnered the views of outside scientific experts who did not have primary affiliations with any of the centers. The committee of outside experts concluded that the ADC program has been very successful, but suggested that some constructive changes could be made in the program to improve Alzheimer’s disease research. Four main recommendations were put forth in the committee’s report (NIA, 2002). The first was to give the centers greater program flexibility to take better advantage of local strengths, interests, and expertise. For example, it was suggested that centers might enroll and follow special patient populations rather than using only clinic populations as has been required up to now. Another example was that centers be allowed to purchase some required services, e.g., postmortem neuropathology or educational programs, from another center or an outside organization such as the Alzheimer’s Association. A second recommendation was to accelerate standardized clinical data collection across ADCs. Although each center would be encouraged to continue collecting data needed for local research interests, additional standardized neuropsychological and neurological data should be collected by all centers and transmitted to the National Alzheimer’s Coordinating Center (NACC) where data from all centers will be pooled for studies requiring large sample sizes. A similar suggestion resulted in the third recommendation, which was that the program promote better use and increased sharing of tissue and data resources among the centers and the general scientific community. The committee suggested expanding the National Alzheimer’s Cell Repository located at Indiana University to increase its capacity to bank cell lines, DNA, and serum from the centers as well as other sources. Another suggestion was that increased use of the frozen or fixed postmortem brain tissue collected and stored at all centers for collaborative studies coordinated by NACC using pooled samples and data could increase statistical power. A fourth recommendation was to decrease the emphasis on late-stage Alzheimer’s disease in favor of more research on the transition from normal aging to mild cognitive impairment and to full-blown Alzheimer’s disease as well as to comparisons to other neurodegenerative diseases. The recommendations of the external review committee were incorporated in the 2003 RFA for ADRCs. NATIONAL INSTITUTE OF NURSING RESEARCH The National Institute of Nursing Research (NINR) uses two types of center awards to support university-based research centers. Nine P30 core
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NIH Extramural Center Programs: Criteria for Initiation and Evaluation grants support interdisciplinary, collaborative nursing research programs at established research institutions, and nine P20 exploratory center grants support nursing schools in the process of developing their research programs. Each center has a broad topic or area of research focus, with little overlap across the 18 centers. Examples of research areas include vulnerable populations, chronic disorders, symptom management, health promotion, and injury mechanisms. All NINR-funded centers are required to have evaluation plans as part of their application, and the annual meeting of center directors in 2001 focused on these program evaluations, specifically whether the centers are meeting their stated objectives and goals and what they have accomplished that they would not have been able to do without center awards. Those discussions were subsequently reported to the NINR Advisory Council (NINR, 2002). The center directors identified a range of benefits of the centers program, including: Enabling nurse researchers to move from relatively small, exploratory studies to more sophisticated “big science” intervention studies; Defining new areas of nursing research; Recruiting new faculty within a particular research area and recruiting graduate students and postdoctoral fellows; Using the centers as a research dissemination vehicle; Developing new evidence-based practice models; Bringing the school of nursing into the larger campus or university by bridging gaps between disciplines, departments, and faculty; Giving faculty members a vehicle to take risks that previously might not have been feasible; Strengthening and expanding community linkages; and Leveraging more research funding from the university. Challenges identified by the center directors were: Devising adequate mentorship strategies and establishing a group of core mentors. For P20s, the key issue was mentoring developing investigators; for the P30s, key issues were mentoring for midcareer researchers and sustained leadership. Accruing and maintaining adequate resources, even though the centers are receiving NINR and other support. Allowing adequate time to achieve the stated goals. For P20s in particular, the three-year lifespan may not be sufficient to develop the research base and infrastructure needed to apply for a P30. Sustaining leadership and a core faculty within the centers.
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NIH Extramural Center Programs: Criteria for Initiation and Evaluation NATIONAL CENTER FOR COMPLEMENTARY AND ALTERNATIVE MEDICINE The director of the National Center for Complementary and Alternative Medicine (NCCAM) convened a panel of outside experts in 2002 to review the NCCAM research center program, which was approaching the end of the initial five-year funding cycle. The panel was asked to examine NCCAM’s system of research centers and determine whether modifications to their present organization and funding were merited. In particular, the panel was asked to consider the role that research centers have played in advancing NCCAM’s mission and how that role should change in the future; important characteristics of future centers; and the most suitable funding mechanisms for various types of centers (NCCAM, 2002). The earliest NIH-funded complementary and alternative medicine (CAM) centers were expected to emphasize outreach to researchers, academic institutions, and the public in addition to conducting research. Each of the centers was to provide technical assistance to investigators, develop bibliographic resources, foster connections between experienced investigators from conventional medicine and those from the CAM community, and establish linkages among academic centers studying alternative medicine. Many of the 10 U24 “exploratory centers” found it difficult to meet these ambitious goals, and as a result, when the U24 CAM centers reached the end of their funding cycles, the goals for the center program were revised and a different funding mechanism was adopted. NCCAM’s present-day Research Centers Program employs P50 specialized center of research grants, which provide more funds ($1.5 million annually versus the $450,000 allotted to the earlier U24 centers) and more focus (centers are expected to carry out three or four R01-like research projects that undergo NIH peer review, conduct pilot research projects, and provide continuing opportunities for research career development). The panel found that, several years into their missions, the current NCCAM research centers had clearly played a role in establishing the visibility and credibility of CAM research, building research infrastructure, and drawing investigators into the field. For these reasons, panel members soundly endorsed the continuation of a vigorous NCCAM Research Centers Program. Nevertheless, the panel also pointed out that the current P50 research centers had not yet developed a consistent record of hypothesis-driven research and publication. Accordingly, the panel members urged that future NCCAM research centers be structured to focus on two or three of the following: A particular disease or class of diseases treated by CAM; A specific group of CAM therapies or treatment approaches; and
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NIH Extramural Center Programs: Criteria for Initiation and Evaluation Mechanisms (or processes) of action of CAM therapies and approaches. The panel also suggested that there may be scientific and fiscal advantages to using funding mechanisms other than P50 grants that dominated NCCAM’s current research centers portfolio. Although it did not stipulate specific funding mechanisms, the panel encouraged NCCAM to select types of awards that encourage investigator autonomy wherever possible. In response, NCCAM restructured its center program to consist of three activities, “each designed to meet a different need”: Centers of Excellence for Research on Complementary and Alternative Medicine funded by P01 grants; Developmental Centers for Research on Complementary and Alternative Medicine funded by U19 cooperative agreements; and International Centers for Research on Complementary and Alternative Medicine funded by R21 grants.3 Additional panel recommendations for future NCCAM centers included: More basic science research in CAM; Opportunities for peer-reviewed pilot research projects; Extending research support and infrastructure to noncenter investigators conducting related research elsewhere; Standardized treatments and therapeutic approaches for large-scale clinical trials; Career development opportunities for conventional and CAM clinicians who have completed their clinical training, especially junior faculty; and Cost-effectiveness or health services research. Finally, panelists recommended that NCCAM carefully monitor the accomplishments of future centers and continue to support only those with exemplary research records. REFERENCES IOM (Institute of Medicine). 1989. A Stronger Cancer Centers Program: Report of a Study. Washington, DC: National Academy Press. Lenfant C. 2002. Strengthening commitment to clinical research: The National Heart, Lung, and Blood Institute’s Specialized Centers of Research program. Circulation 105(4):400-401. [Online]. Available: http://www.nhlbi..nih.gov/funding/fromdir/circ-1-02.htm [accessed December 15, 2003]. 3 PAS-03-038.
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NIH Extramural Center Programs: Criteria for Initiation and Evaluation NCAB (National Cancer Advisory Board). 2003. Advancing Translational Cancer Research: A Vision of the Cancer Center and SPORE Programs of the Future. Report of the National Cancer Advisory Board Ad Hoc P30/P50 Working Group. [Online]. Available: http://deainfo.nci.nih.gov/ADVISORY/ncab/p30-p50/P30-P50final12feb03.pdf [accessed December 15, 2003]. NCI (National Cancer Institute). 1996. Report of the National Cancer Institute Cancer Centers Program Review Group. Bethesda, MD: National Cancer Institute NCCAM (National Center for Complementary and Alternative Medicine). 2002. NCCAM Research Centers Program Expert Panel Review. [Online]. Available: http://nccam.nih.gov/about/plans/centers/report.pdfx [accessed January 8, 2003]. NHLBI (National Heart, Lung, and Blood Institute) 2001. Report from the Committee to Redefine the Specialized Centers of Research Programs. [Online]. Available: http://www.nhlbi.nih.gov/funding/scor_report.pdf [accessed December 15, 2003]. NIA (National Institute on Aging). 2002. Report of the Alzheimer’s Disease Centers External Advisory Meeting. [Online]. Available: http://www.nia.nih.gov/news/alzadvmtg.htm [accessed December 15, 2003]. NIAMS (National Institute of Arthritis and Musculoskeletal and Skin Diseases). 1997. Executive Summary, Report to the Institute Director of the Centers Working Group II. [Online]. Available: http://www.niams.nih.gov/ne/reports/sci_wrk/1997/cenrptfn.htm [accessed December 15, 2003]. NICHD (National Institute of Child Health and Human Development). 1999. “Report of the Demographic and Behavioral Sciences Branch Population Centers Review.” [Online.] Available: http://www.nichd.nih.gov/about/cpr/dbs/pubs/report.pdf [accessed December 15, 2003]. NIDCD (National Institute on Deafness and Other Communication Disorders. 1998. Report of the Work Group on Single and Multiple Project Grants Report. Bethesda, MD: National Institute on Deafness and Other Communication Disorders. NINR (National Advisory Council for Nursing Research). 2002. Minutes of the Advisory Council of May 21-22, 2002. [Online]. Available: http://www.nih.gov/ninr/about/may_min02.pdf [accessed December 15, 2003]. OAR (Office of AIDS Research). 1996. Report of the NIH AIDS Research Program Evaluation Working Group of the Office of AIDS Research Advisory Committee (“Levine Report”). [Online]. Available: http://www.nih.gov/od/oar/public/pubs/levine.pdf [accessed December 15, 2003]. OAR. 1999. Report to the Director, Office of AIDS Research, of the Focus Group to Review the Centers for AIDS Research (CFAR) Program. [Online]. Available: http://www.nih.gov/od/oar/public/CFARrpt090899.pdf [accessed December 15, 2003].
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Representative terms from entire chapter: