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Background Appreciating the need to better translate biomedical research into improved clinical care and health, the NIH Roadmap was initiated in 2003 to focus on this by strengthening NIH’s central role in clinical research and clinical research training. As part of the needed re-engineering, in 2006 NIH began the CTSA program. At this writing (Summer 2009), there are 39 CTSAs at leading universities across the United States, each having a clinical research graduate program and extensive resources for promoting clinical and translational research. Each of these, and the CTSA Consortium as a whole, are committed to transforming clinical and translational research to maximize impact on health. The CTSAs bring to this challenge an array of capacities, extensive research infrastructure, formal training and career development programs, community engagement of the public and of clinical practice communities, and informatics related to research and clinical practice. Various CTSAs have different areas of emphasis, including along the spectrum of translational research from bench to patient bedside (the first translational step, “T1”), from the bedside to general use in clinical practice (“T2”), and from clinical practice to public benefit and policy (“T3”). This broad array of activities has allowed the national consortium to be responsive to needs all along this path of translation of biomedical research into practice and public benefit. Although the activities of CER can be seen as primarily involving T2 and T3 research, they also can be seen as focusing on the optimal translation of T1 research into effective treatment, and thus the very epitome of work in which CTSAs should be deeply involved. This appreciation was reinforced by CER’s selection as a key Strategic Goal focus of the CTSA Consortium. In this context, the CER Strategic Goal of the CTSA Consortium is to promote the translation of the results of clinical and translational research into practice and public policy. In service of this, in two sections below, we review the span of CER resources across the CTSA Consortium and propose potential roles for CTSAs in supporting CER. As a point of reference for this White Paper, below are two important definitions of CER from reports released at the end of June 2009, from the IOM and from the FCC-CER: Definition from the IOM Report on Priorities for CER The generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition or to improve the delivery of care. The purpose of CER is to assist patients, clinicians, purchasers, and policy makers, and the public to make informed decisions that will improve healthcare at both the individual and population levels.

In 2006, the National Institutes of Health (NIH) created the Clinical and Translational Science Award (CTSA) program to “transform the local, regional and national environment for clinical and translational science, thereby increasing the efficiency and speed of clinical and translational research.”1 Since then, 61 CTSA-funded sites have reengineered their local research enterprises to develop cadres of highly trained translational scientists and provide them with a robust array of research resources. Now under the direction of the National Center for Advancing Translational Science (NCATS), the maturing CTSA program is poised to enter its second stage of development to provide “institutions with greater flexibility and more opportunities to build on institutional strengths.”2 This approach is supported by a new CTSA Funding Opportunity Announcement (FOA) that will enable CTSA sites to develop programs to address the specific needs of their investigators and local communities. As a result, institutional CTSA programs will likely evolve from a model that provides a set of common research resources locally to unique programs with a mix of core infrastructure (e.g., training, informatics) that is supplemented by institution-specific resources (e.g., drug discovery, comparative effectiveness research, and research implementation and dissemination cores). Leveraging complementary institutional capabilities through closer collaborations between CTSA sites is the logical next step for the National CTSA Consortium. During the formative years of the CTSA program, several sites forged collaborations by creating regional consortia based on geographic proximity to enable sharing of local resources and meetings of trainees.3 For example, the Chicago Consortium for Community Engagement represents a collaboration among the three Chicago CTSAs to advance coordinated and synergistic approaches to developing community-partnered research, disseminating research results, and providing training in community engagement methods to collaborators in academic and community-based organizations. The Ohio Consortium of three CTSA sites implemented a statewide central institutional review board model. In Texas, several institutions meet to exchange best practices. However, collaborative efforts that are constrained by geographic location may limit the benefits that can be derived from linking scientists, institutions, resources, and innovative tools across an array of institutions with complementary capabilities. Accordingly, six geographically dispersed CTSA sites (Johns Hopkins University, University of Chicago, University of Pennsylvania, University of Pittsburgh, Washington University at St. Louis, Yale University) formed a “virtual CTSA consortium” based on a shared vision for data sharing and prior collaborations focused on informatics initiatives. The initial goals of the six-site Sharing Partnership for Innovative Research in Translation (SPIRiT) Consortium were 1) to develop a data sharing infrastructure for biospecimen-based research and de-identified clinical research data, and 2) to establish inter-institutional collaborations related to pilot studies, regulatory support, core laboratory facilities, and education and career development. Over the past two years, the SPIRiT Consortium embarked on several initiatives to achieve these goals, including the deployment of an informatics software and regulatory infrastructure to enable discovery and sharing of banked pathology specimens, development of an inter-institutional pilot study program to link investigators, and validation of a novel technology to improve the diagnosis of malignant melanoma. These programs are described below.