THE CTSA PROGRAM AT NIH
Opportunities for Advancing Clinical and Translational Research
Committee to Review the Clinical and Translational Science
Awards Program at the National Center for Advancing
Board on Health Sciences Policy
Alan I. Leshner, Sharon F. Terry, Andrea M. Schultz
and Catharyn T. Liverman, Editors
INSTITUTE OF MEDICINE
OF THE NATIONAL ACADEMIES
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NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine.
This project was supported by a contract between the National Academy of Sciences and the National Institutes of Health (Award No. HHSN26300001). The views presented in this publication are those of the editors and attributing authors and do not necessarily reflect the view of the organizations or agencies that provided support for this project.
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Suggested citation: IOM (Institute of Medicine). 2013. The CTSA Program at NIH: Opportunities for advancing clinical and translational research. Washington, DC: The National Academies Press.
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COMMITTEE TO REVIEW THE CLINICAL AND TRANSLATIONAL SCIENCE AWARDS PROGRAM AT THE NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES
ALAN I. LESHNER (Chair), American Association for the Advancement of Science, Washington, DC
SHARON F. TERRY (Vice-Chair), Genetic Alliance, Washington, DC
SUSAN AXELROD, Citizens United for Research in Epilepsy, Chicago, IL
ENRIQUETA C. BOND, Burroughs Wellcome Fund (Emeritus), Marshall, VA
ANN C. BONHAM, Association of American Medical Colleges, Washington, DC
SUSAN J. CURRY, University of Iowa, Iowa City
PHYLLIS A. DENNERY, University of Pennsylvania, Philadelphia
RALPH I. HORWITZ, GlaxoSmithKline, King of Prussia, PA
JEFFREY P. KAHN, Johns Hopkins University, Baltimore, MD
ROBIN T. KELLEY, National Minority AIDS Council, Washington, DC
MARGARET MCCABE, Boston Children’s Hospital, MA
EDITH A. PEREZ, Mayo Clinic, Jacksonville, FL
CLIFFORD J. ROSEN, Maine Medical Center Research Institute, Scarborough
CATHARYN T. LIVERMAN, Study Director
ANDREA M. SCHULTZ, Study Director
MARGARET A. MCCOY, Program Officer (beginning March 2013)
CLAIRE F. GIAMMARIA, Research Associate
JUDITH L. ESTEP, Program Associate
ANDREW M. POPE, Director, Board on Health Sciences Policy
VICTORIA WEISFELD, Technical Writer
This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the National Research Council’s Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published report as sound as possible and to ensure that the report meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. We wish to thank the following individuals for their review of this report:
Gordon R. Bernard, Vanderbilt University
Wylie Burke, University of Washington
Jonathan Davis, Tufts University School of Medicine
Jaqueline B. Fine, Merck Research Laboratories
Garret A. FitzGerald, University of Pennsylvania School of Medicine
Robert C. Gallo, University of Maryland School of Medicine
Margaret Grey, Yale University School of Nursing
Kevin Grumbach, University of California, San Francisco
William N. Kelley, University of Pennsylvania School of Medicine
Michael D. Lairmore, University of California, Davis
Elizabeth O. Ofili, Morehouse School of Medicine
Bray Patrick-Lake, Clinical Trials Transformation Initiative
Doris Rubio, University of Pittsburgh
Although the reviewers listed above have provided many constructive comments and suggestions, they did not see the final draft of the report before its release. The review of this report was overseen by Floyd E. Bloom, The Scripps Research Institute. Appointed by the Institute of Medicine, he was responsible for making certain that an independent examination of this report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this report rests entirely with the authoring committee and the institution.
Private- and public-sector investment in health care is immense, and wide agreement exists in both sectors that the U.S. health care system needs to be improved in many ways in order to reduce costs and provide equitable access to high-quality care. The availability of cutting-edge technologies and new preventive and therapeutic interventions is a result of the United States’ historic investment in biomedical and health research. New efforts in clinical and translational research hold great promise for even more effective and efficient ways to improve the health of our population. Investments in research support tools, informatics, infrastructure, and training and education are essential to facilitate new discoveries and to move promising discoveries in basic science and clinical research into use in clinics, hospitals, and homes.
In 2006, the National Institutes of Health (NIH) began an investment in the Clinical and Translational Science Awards (CTSA) Program, a bold initiative aimed at facilitating and accelerating clinical and translational research—lofty and challenging goals. Simultaneously building on a legacy program (NIH’s General Clinical Research Center Program) and pioneering a new initiative is never easy.
Our Institute of Medicine (IOM) committee was given the task of assessing progress and recommending a path forward to help improve the efficiency and effectiveness of one of the nation’s most important resources for clinical and translational science. As we assessed the CTSA Program, we were fully cognizant of both the importance of our task and the opportunity it presented. Among our conclusions was that the CTSA Program has had many initial successes in creating academic homes for clinical and translational research, providing education and training, and beginning to build the tools and partnerships needed to advance clinical
and translational science. As requested by the sponsor, we identified ways the program can be strengthened.
The future of the CTSA Program is exciting, as well as daunting. Although there is great potential for the creation of new preventive and treatment approaches, there remain numerous institutional, logistical, and methodological barriers to doing so. Moving clinical and translational research forward will greatly benefit from the strong leadership, creative partnerships, and institutional commitments that the CTSA Program can bring to this effort.
It was our pleasure and privilege to lead the efforts of this IOM committee—superb committee members and outstanding staff who have worked diligently to learn about this complex program and contemplate the potential for its future. The expertise and grace of these generous individuals combined to create deep discourse and solid consensus.
We thank everyone who provided testimony, gave presentations, and participated in discussions with the committee. We are grateful to the staff of the National Center for Advancing Translational Sciences (NCATS) who responded thoroughly to our numerous inquiries. The committee is truly appreciative of the many individuals who provided the diversity and breadth of knowledge and opinion needed to complete this study.
The CTSA Program has made some remarkable progress to date and has great potential to further advance clinical and translational science and improve human health. We look forward to seeing this potential fully realized in the coming years.
Alan I. Leshner, Chair
Sharon F. Terry, Vice-Chair
Committee to Review the Clinical and Translational Science Awards Program at the National Center for Advancing Translational Sciences