UC Davis Clinical and Translational Science Center
Lars Berglund, M.D., Ph.D., University of California, Davis
The University of California, Davis (UC Davis) is proposing to create a Clinical and Translational Science Center (CTSC) that will transform its medical research enterprise into a highly effective “open” academic home for clinical and translational research by building on three key assets: 1) a long-standing commitment as a land-grant university to serve the geographically dispersed and ethnically diverse populations of inland and northern California with a health care system enabled by one of the broadest and most extensive telecommunications programs in the world; 2) the collaborative culture of UC Davis, which has one of the most extensive and interdisciplinary life science environments in the country; and 3) an established CTSC pilot facility — the UC Davis Clinical Research Investigator Services Program (CRISP) — that serves as the physical home for clinical and translational research, and for faculty training and career development. CRISP is a fundamentally important CTSC testing ground where many perceived CTSC barriers have been explored and solutions have been tested. Through CRISP, UC Davis has completed the planning phase for CTSC.
In the structure of CTSC, considerable attention is paid to create an organization that is: 1) responsive and familiar to investigators; 2) flexible; 3) well linked to university leadership, participating academic units and the community; and 4) focused on the goal of reducing barriers and facilitating the translation of research gains into medical practice. Key features are: an education program focused on team science; extensive collaborations across UC Davis colleges and centers, introduction of catalyst functions, such as collaborative research facilitators and translational postdoctoral fellowships, dissemination through teletechnology, flexible use of resources for patient-oriented research, and a community engagement program emphasizing trust and respect.
CTSC is under the leadership of two co-principal investigators, Drs. Berglund M.D., Ph.D., and Joseph M.D., Ph.D., supported by a team of directors and co-directors that oversees each of the nine CTSC programs, and a comprehensive committee structure, designed to firmly anchor CTSC with institutional leadership, faculty, trainees and the community. CTSC will be implemented through a carefully designed collaborative plan, and the activity will be guided through continuous evaluations and corrections.
UCSF Clinical and Translational Science Institute
San Francisco, California
S. Clay Johnston, M.D., Ph.D., University of California, San Francisco
Despite explosive gains in our understanding of the basic mechanisms of human disease, meaningful translation of this knowledge to the treatment and prevention of disease has moved slowly. To accelerate the pace at which discoveries in basic science can serve the health of our patients and community, the University of California, San Francisco (UCSF) intends to establish a Clinical and Translational Science Institute (CTSI). Its mission will be to create a comprehensive, integrated academic home that promotes research and education in clinical and translational science at UCSF, at affiliated institutions, and in participating communities.
Its goals are: 1) to support, enhance and integrate existing training programs, increasing the number of trainees from diverse disciplines and improving the quality of their training in clinical and translational research methods; 2) to support, improve and integrate existing infrastructure to enhance the design and implementation of clinical and translational studies, fostering collaborations to achieve a diverse spectrum of high-quality, original research; 3) to enhance career development of clinical and translational researchers by providing mentoring and opportunities to catalyze original research, and by changing the academic culture to appropriately reward multidisciplinary collaborative work; and 4) to create a virtual home providing contemporary communications to simplify collaboration, to provide an optimal informatics matrix for conducting innovative research, and to nurture the growth of clinical and translational science.
To reach these goals, UCSF is transforming its clinical and translational research organization to establish 13 interrelated programs that will provide the training, services and opportunities needed. These programs are led by senior scientists drawn from diverse disciplines in each of UCSF's four health science schools — dentistry, medicine, nursing and pharmacy — and its graduate division. The plans reflect input from more than 200 interested, energetic and committed participants from throughout the community, including most of UCSF's academic leaders. These individuals worked collaboratively to ensure inclusion, transparency and flexibility in the design and planned implementation of CTSI.
UCSF believes that this infusion of new energy and resources will create and sustain a rich environment for innovative research and drive the realization of UCSF's full potential to educate and to support the work of clinical and translational scientists. If so, biomedicine will be advanced, and the health of our patients and the community will benefit.
Yale Center for Clinical Investigation
New Haven, Connecticut
Robert S. Sherwin, M.D., Yale University
The Yale Center for Clinical Investigation (YCCI) was created to provide a home for training the next generation of clinical investigators. Key programmatic goals are: 1) Attract highly talented students and junior faculty across medicine, nursing, public health, biological sciences and biomedical engineering; train them in the use of state-of-the-art research tools; give them the skills to work within complex research teams; and support their professional development. 2) Foster the translation of disease-related discoveries from the laboratory into the community by stimulating the creation of interdisciplinary teams; making available state-of-the-art core facilities and expanded biostatistical and bioinformatics resources; establishing organizational and regulatory infrastructure for clinical studies; and forging a dynamic new partnership that will integrate community leaders, physicians and health centers. Participating institutions include the schools of medicine, nursing and public health; the Department of Biomedical Engineering; and graduate programs in biological and biomedical sciences.
The investigative medicine program (IMP) is central to YCCI's education and training efforts. It is a unique doctoral program that offers Ph.D. degrees in health sciences research to highly qualified M.D. fellows embarking on careers in translational or clinical research. IMP will be expanded with CTSA support to include nursing, public health biological sciences, and M.D.-Ph.D. students. YCCI has also created a Society of YCCI Faculty Mentors who will participate actively in the training and nurturing of the students and junior faculty members identified as YCCI Clinical Scholars. Pilot and feasibility grants will be awarded for: 1) junior faculty, 2) interdisciplinary translational teams, 3) new technologies, and 4) community-based projects. YCCI will cluster research cores around common themes, including imaging, specimen analysis, physiology, cognition and behavior, drug development, and cell therapy. A new office of research services will provide facilities for one-stop shopping for regulatory, biostatistical, bioinformatics, recruitment and other support services. YCCI will have an office to coordinate the university's efforts to address health issues facing our community. The university's decision to immediately provide substantial support to establish the YCCI reflects its strong commitment to an innovative redesign of our clinical and translational research activities.
Mayo Clinic Center for Translational Science Activities
Robert Rizza, M.D., Mayo Clinic
The goal of the Mayo Clinic CTSA application is to present Mayo's vision for the integration and expansion of its innovative clinical and translational research activities, so that a highly functional academic home for clinical and translational research is developed at the Mayo Clinic. The Center for Translational Science Activities is founded on the Mayo Clinic's long-standing excellence in and commitment to clinical and translational research, which includes the support of key infrastructure and a commitment to career development. To achieve this goal, Mayo will take a comprehensive approach to the key elements of the CTSA Request for Applications and focus on enhancing: 1) clinical research core resources that provide innovative tools to investigators; 2) career development and education programs that prepare the next generation of investigators; 3) compliance and regulatory affairs support that ensures patient safety and privacy, and customer service-oriented approaches to support investigative teams; 4) community affairs support to enhance participation, diversity and community support for clinical and translational research; 5) collaboration with industry and clinical practices to translate research discoveries into routine clinical practice; and 6) continued and expanded institutional support that includes an academic home for clinical and translational research. The Mayo Clinic also proposes a consolidated governance plan that incorporates strong data-driven evaluation of each Center for Translational Science Activities element and the program as a whole. In principle, the CTSA program is consistent with the historical, conceptual and philosophical underpinnings of the Mayo Clinic, and this application clearly articulates how the overarching and transformative goals of the CTSA program can be met at Mayo. To summarize, the Mayo Clinic Center for Translational Science Activities will bring together all the resources of the five schools within the Mayo Clinic College of Medicine, and more than 100 years of scientific and medical research expertise, to discover innovative new methods that will speed the translation of research results into therapies, tools and patient care practices that impact all members of the local and national communities. This vision is entirely consistent with the stated mission of the Mayo Clinic to provide the best care to every patient, every day, through integrated clinical practice, education and research.
Irving Institute for Clinical and Translational Research
New York, New York
Henry Ginsberg, M.D., Columbia University
Columbia University Medical Center's (CUMC) CTSA program will transform the culture of clinical and translational research so that CUMC can develop and retain an outstanding cadre of senior faculty to lead the next generation of clinical and translational investigators. With enhanced support from the CUMC-Herbert Irving Endowment, which will increase from its present level of $15 million to $25 million, CUMC will accomplish this goal by creating the Irving Institute for Clinical and Translational Research (IICTR). IICTR will be the academic and intellectual home for the next generation of clinical and translational investigators. The senior faculty will provide leadership and stature for IICTR, and serve as mentors for both the junior faculty and IICTR trainees. The junior faculty, called Irving Fellows, will work with senior faculty to develop novel approaches to advancing multi- and interdisciplinary clinical and translational research. The Irving Fellows will be role models for the way multi- and interdisciplinary research should be conducted at CUMC. The resources provided by IICTR will include outstanding support and research in biomedical informatics, biostatistical and clinical trial design, bioethics, regulatory issues, patient-oriented research, and core laboratory resources. The Irving Fellows will be supported by CUMC and the CTSA, as will pilot and collaborative research grants awarded annually by IICTR. CUMC has invested in the development of new space for IICTR, including space for pediatric inpatient/outpatient research and the Center for Clinically Oriented Research Education, which will be a home for trainees and faculty. CUMC will also develop a new off-campus research center to support community-based clinical and translational research, and education. As part of the CTSA program, CUMC has created an integrated educational program that includes a new multidisciplinary, patient-oriented research master's degree, a novel K12 scholars mentored research program in muti- and interdisciplinary research, and a pioneering multidisciplinary, patient-oriented research Ph.D. program. The goal of IICTR and the CTSA program is to enable more direct utilization of research advances to benefit patients and the community.
Rockefeller University Center for Clinical and Translational Science
New York, New York
Barry Coller, M.D., Rockefeller University
The Rockefeller University Hospital, originally a General Clinical Research Center awardee since 1963, has been the continuous home for clinical and translational science at Rockefeller since 1910. It has been the site of numerous landmark scientific and clinical contributions, and many of its trainees have gone on to become academic leaders. With the new resources available under a Clinical and Translational Science Award (CTSA), a core faculty of distinguished investigators, whose research spans the basic-translational spectrum and encompasses a broad range of scientific and medical disciplines, integrates and expands Rockefeller University's scientific and educational programs in the Rockefeller University Center for Clinical and Translational Science. The new center transforms clinical and translational research by encouraging new studies, enhancing and centralizing the support structures required to conduct studies with scientific rigor, and ensuring an absolute commitment to the protection of human subjects and participant safety. The key elements in the transformation are: 1) a new governance structure reflecting the NIH cooperative agreement (U54) assistance mechanism; 2) creation of a new K12 Clinical Research Scholars Program offering master's and Ph.D.-level degrees to complement the current Clinical Scholars Program; 3) infrastructure enhancements to facilitate the development and conduct of clinical protocols under the principle of good clinical practice, including biomedical informatics, biostatistics, bionutrition, research nursing, research pharmacy, participant recruitment and community engagement, and regulatory support and oversight from the clinical research (research subject advocate) support office; and 4) development of innovative and novel core methodologies related to dendritic cell therapy; vaccine development for HIV, hepatitis C and malignancies; genetics/genomics; assessing the immune response; and metabolic phenotyping. The center continues Rockefeller's tradition of focusing on the interface between scientific discovery; human pathophysiology; and novel diagnostic, preventive and therapeutic strategies. It partners with industry, when mutually beneficial, to achieve these goals. The center is an active member of the national CTSA consortium, offering the consortium novel ideas and tools for conducting and evaluating clinical and translational research. It eagerly adopts the best practices identified by the consortium and adheres to the standards set by the consortium.
University of Rochester Clinical and Translational Science Institute
Rochester, New York
Thomas Pearson, M.D., M.P.H., Ph.D., University of Rochester Medical Center
The University of Rochester Clinical and Translational Science Institute (CTSI), funded through the Clinical and Translational Science Award program, serves as the academic home for clinical and translational science at the university. The CTSI acts as a hub, integrating clinical and translational science programs and related academic departments with four affiliated URMC research centers, namely the Center for Human Experimental Therapeutics, the Clinical Research Center, the Center for Research Implementation and Translation, and the Center for Community Health.
Since its inception in 2006, the CTSI has achieved many noteworthy accomplishments: 1) Created and supports the UNYTE Translational Research Network made up of 18 biomedical research institutions in and near Upstate New York. Among other things, UNYTE implemented a model for collaborative Institutional Review Board review of multisite protocols to accelerate the approval time for research studies conducted within the network. 2) Established a Research Navigator program to facilitate, accelerate and improve collaboration in clinical and translational research within the URMC, across the UNYTE network, and throughout the CTSA Consortium. 3) Initiated and supports the Greater Rochester Practice-Based Research Network, which consists of 85 pediatric, internal medicine and family medicine practices that serve 30 percent of the adult and 80 percent of the pediatric population in the region. 4) Created an innovative new Ph.D. program to prepare individuals for academic and clinical careers related to the translation of basic biomedical research into clinical strategies to improve health.
Duke Translational Medicine Institute
Durham, North Carolina
Robert Califf, M.D., Duke University
Duke University established the Duke Translational Medicine Institute (DTMI) to: 1) Create an institute that transforms how fundamental discoveries are translated into improved medical care by supporting creative translational research teams. The institute provides leadership and resources for original translational and clinical research, and it develops and performs studies regarding novel methods and approaches to translational and clinical science. 2) Create an environment in which trainees at all levels, including medical and nursing school students, physical therapists, pharmacologists, house staff, fellows, graduate students, junior faculty and career transition faculty can be trained in translational and clinical research. The training is built on the principle that a rich clinical and translational research environment provides Duke University trainees with models and opportunities for success. 3) Integrate translational and clinical science by fostering collaboration among Duke University's departments, institutes, centers and schools, using human resources supported by modern bioinformatics and a clinical research unit designed to integrate intensive measurements of biological processes. 4) Develop a community model for understanding how to translate the findings of research from bench to bedside, to populations using advanced informatics and health services delivery methods. The Duke University DTMI is founded on three entities, or pillars, including Duke University Translational Research Institute (DTRI), Duke University Clinical Research Institute (DCRI) and Duke University Center for Community Research (DCCR). These three entities bring together and expand existing programs and are designed to emphasize the continuities along the spectrum of research that begins in a basic science laboratory and concludes with novel therapies that change outcomes for individual patients. These three pillars — DCRI, DTRI and DCCR — are administratively joined into DTMI, which links with other key programs, including Duke University Comprehensive Cancer Center, Duke University School of Nursing, and Duke University Institute for Genome Sciences and Policy, thereby creating a comprehensive home for clinical and translational researchers. The creation of DTMI is relevant to public health as it creates an environment that fosters speedier delivery of new interventions and health care practices to the community.
Oregon Clinical and Translational Research Institute
Eric Orwoll, M.D., Oregon Health and Science University
Biomedical research institutions in Oregon are prepared for a major expansion in clinical and translational investigation. The university has formed the Oregon Clinical and Translational Research Institute (OCTRI). OCTRI has fundamentally changed biomedical research by creating a vibrant academic home for clinical and translational investigation. It will leverage existing strengths and remove barriers to the pace and growth of research. At the heart of OCTRI is a robust partnership between Oregon Health & Science University (OHSU) and Kaiser Permanente's Center for Health Research (KPCHR) that brings together a strong biomedical research university and an innovative practice-based research center associated with a large patient population. The collaboration provides unique opportunities for expansion across the spectrum of human investigation and sets the stage for major advances in human health. Transformation of clinical and translational research in Oregon is enhanced by robust institutional support for the OCTRI, manifest by significant administrative change as well as the commitment of substantial financial and space resources; academic faculties at OHSU and KPCHR that fully support the OCTRI initiative and the development of a strong, multidisciplinary OCTRI leadership team; merging of resources to form a coordinated infrastructure for clinical and translational research; and strong ties to the community and the involvement of the region in the human research agenda. OHSU has identified three major goals for OCTRI, and proposed far-reaching, explicit, and feasible approaches to achieve them. The university will: 1) create an academic home specifically devoted to the discipline of clinical and translational research; 2) nurture a new cadre of highly-trained, interdisciplinary investigators through a strong, diverse educational curriculum; and 3) create a “research commons” — a coordinated infrastructure of core research tools that greatly expands research opportunities and provides a unified, effective means for their access. There are particular opportunities to accelerate progress in pediatric and child health, community based research, and human genetics.
University of Pennsylvania Institute for Translational Medicine and Therapeutics
Garret FitzGerald, M.D., University of Pennsylvania
The Clinical and Translational Research Award (CTSA) has been greeted enthusiastically by the University of Pennsylvania (Penn) and its partner institutions. The Penn-led proposal was funded in the first round of CTSAs, and Penn has just completed its renewal. The overarching themes of the Penn proposal are: 1) fostering the development of translational therapeutics and 2) bridging the artificial divide between pediatric and adult physiology and disease. A strategic plan had identified clinical and translational research as a priority, leading to the formation of the Institute for Translational Medicine and Therapeutics (ITMAT) in January 2005. ITMAT anticipated many aspects of the CTSA — amongst them, inclusion of dedicated “dry” and “wet” bench space for translational research and a robust educational program, configured on a Master in Translational Research (MTR). This CTSA application prompted intra- and interinstitutional consideration of how to build on this achievement. This has forged a transformational alliance between Penn, the Children's Hospital of Philadelphia (CHOP), the Wistar Institute (WI) and the University of the Sciences in Philadelphia (USP). Faculty from 9 of the 12 schools at Penn and from the partner institutions are represented in leadership roles in the response to this CTSA. ITMAT, designated as the academic home for clinical and translational research, has been broadened to serve a transinstitutional role. Its structure has been transformed to foster interdisciplinary science from discovery of new molecules through to the study of drug action in large populations. This has been accomplished by developing interdisciplinary centers, related cores, innovative interdisciplinary programs of research and strategies to engage and inform communities and their physicians. A particular emphasis has been placed on training and innovative programs, which cover the entire career span, engaging undergraduate students through to mature clinicians. The proposal includes the flexible use of the MTR and new tracks in the Master in Clinical Epidemiology (MSCE) with the M.D., Ph.D., V.M.D., M.S.N., D.M.D., and M.B.A. degrees; dedicated slots for medical school entrants pursuing M.D.-MTR/MSCE degrees; and the flexible use of diverse faculty tracks at Penn and CHOP to broaden physician engagement in research. These initiatives will be pursued in partnership with industry, the State of Pennsylvania, the Food and Drug Administration (FDA), and a national network of institutions holding CTSAs. Specifically, Penn and the FDA signed a memorandum of understanding to pursue jointly educational and programmatic initiatives in the area of translational therapeutics under the guidance of ITMAT. In summary, this initiative has fostered: 1) an integrated strategy to develop clinical and translational research by Penn, CHOP, the WI and USP — more than 900 investigators from these institutions are now members of ITMAT; and 2) the transformation and expansion of ITMAT. This has permitted the development of interdisciplinary structures designed to foster and facilitate research and education in this emerging discipline.
University of Pittsburgh Clinical and Translational Science Institute
Steven Reis, M.D., University of Pittsburgh
As one of the nation's leading academic research centers, the University of Pittsburgh has embraced the opportunity and obligation to take the inherent risks associated with reengineering a successful research enterprise and to undertake a transformative initiative, resulting in the development and advancement of clinical and translational science as a distinct discipline in western Pennsylvania. The university demonstrated its commitment to transforming its culture, environment and structure to achieve this goal by forming the Clinical and Translational Science Institute (CTSI). The CTSI serves as the integrative academic home for clinical and translational scientists across the university's six health sciences schools, Carnegie Mellon University, the University of Pittsburgh Medical Center (UPMC) and the region.
CTSI focuses primarily on developing, nurturing and supporting a cadre of clinical and translational scientists by building on the university's existing clinical research training programs to establish a comprehensive program with activities ranging from early research exposure for high school students to advanced doctoral programs. Through integration and innovation, CTSI excels in the development of new biomedical knowledge and the translation of that knowledge from the basic and preclinical research settings to individuals, communities and health practice. The CTSI Center for Clinical and Translational Informatics, which is developing translational research informatics tools for the National Cancer Institute's Cancer Biomedical Informatics Grid initiative, infuses informatics tools into the entire lifecycle of clinical research studies and has developed an online collaborative research community. Innovative, interdisciplinary research initiatives have been developed through the 10 CTSI resource cores, and translated to health practice via a novel CTSI community partnership program and through centralization of UPMC's extensive clinical networks. The resulting transformations in the institution, scientists, research and health practice has improved health locally, regionally and nationally.
Center for Clinical and Translational Sciences
David Dugald McPherson, M.D., University of Texas Health Science Center at Houston
Robert C. Bast, Jr., M.D., University of Texas Health Science Center at Houston
Daniel D. Karp, M.D., University of Texas Health Science Center at Houston
Roberta B. Ness, M.D., M.P.H., University of Texas Health Science Center at Houston
The University of Texas Health Science Center at Houston (UTHSC-H) has established a Center for Clinical and Translational Sciences (CCTS) at the Texas Medical Center (TMC) in Houston. Participating faculty and trainees in CCTS include those from the UTHSC-H component degree-granting schools, including its Medical School, School of Public Health, Graduate School of Biomedical Sciences, School of Health Information Sciences, School of Nursing, Dental Branch, and Brown Foundation Institute of Molecular Medicine, as well as collaborating faculty/facilities of The University of Texas M.D. Anderson Cancer Center (MDACC), which also is located in the TMC. The academic home for CCTS is housed in 11,422 square feet of recently renovated space at the UT Medical School, which is physically joined to Memorial Hermann-Texas Medical Center and serves as its partner and primary teaching hospital. The CCTS home administers all aspects of CCTS; and provides space and resources for faculty and trainees, along with expertise in study design, biostatistics, regulatory issues, ethics, bioinformatics, funding of pilot and feasibility studies, provision of resources, protected time for clinical and translational faculty and trainees, and interactions/collaborations with the various communities and industry. For participant and clinical interactions resources, CCTS has subsumed the UTHSC-H General Clinical Research Center (GCRC) at Memorial Hermann, the satellite UTHSC-H GCRC at Brownsville, Texas, and, in part, the MDACC Clinical and Translational Research Center, to enhance research productivity and efficiency. In its educational component, CCTS has subsumed, in part, the current Center for Clinical Research and Evidence-Based Medicine, which has developed and currently provides formal classes, mentoring, and a Master of Clinical Research degree at UTHSC-H, and an active K30 award at MDACC. Also proposed in the original application was a novel T32 application offering combinations of master's and doctoral degrees in community health sciences, biomedical sciences and/or biomedical informatics — primarily for pre-doctoral students — and a K12 application for post-doctoral trainees and junior faculty. CCTS also has subsumed core translational laboratories, including a genotyping/sequencing core; a biomarkers core offering DNA microarray, RT-PCR and proteomics services; an immune monitoring core; an MRI core; and a biobanking core. A CCTS think tank composed of highly accomplished translational and clinical investigators, basic scientists and educators, and community representatives has come together as an engine for innovation to bring forward and recommend the application of novel and emerging scientific information, methods and technologies to research into human health and diseases across specialties, disciplines and communities.