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
Translational Sciences

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

THE NATIONAL ACADEMIES PRESS

Washington, D.C.

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Committee to Review the Clinical and Translational Science Awards Program at the National Center for Advancing Translational Sciences Board on Health Sciences Policy Alan I. Leshner, Sharon F. Terry, Andrea M. Schultz and Catharyn T. Liverman, Editors

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THE NATIONAL ACADEMIES PRESS • 500 Fifth Street, NW • Washington, DC 20001 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. International Standard Book Number-13: 978-0-309-28474-5 International Standard Book Number-10: 0-309-28474-0 Additional copies of this report available for sale from the National Academies Press, 500 Fifth Street, NW, Keck 360, Washington, DC 20001; (800) 624-6242 or (202) 334-3313; http://www.nap.edu. For more information about the Institute of Medicine, visit the IOM home page at: www.iom.edu. Copyright 2013 by the National Academy of Sciences. All rights reserved. Printed in the United States of America The serpent has been a symbol of long life, healing, and knowledge among almost all cultures and religions since the beginning of recorded history. The serpent adopted as a logotype by the Institute of Medicine is a relief carving from ancient Greece, now held by the Staatliche Museen in Berlin. 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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The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Ralph J. Cicerone is president of the National Academy of Sciences. The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding engineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. C. D. Mote, Jr., is president of the National Academy of Engineering. The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Institute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Harvey V. Fineberg is president of the Institute of Medicine. The National Research Council was organized by the National Academy of Sciences in 1916 to associate the broad community of science and technology with the Academy’s purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Ralph J. Cicerone and Dr. C. D. Mote, Jr., are chair and vice chair, respectively, of the National Research Council. www.national-academies.org

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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 IOM Staff 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 Consultant VICTORIA WEISFELD, Technical Writer v

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Reviewers 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 vii

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viii REVIEWERS Although the reviewers listed above have provided many construc- tive 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 Insti- tute of Medicine, he was responsible for making certain that an inde- pendent 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 entire- ly with the authoring committee and the institution.

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Preface 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 re- search. 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 clini- cal 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 transla- tional 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 as- sessing progress and recommending a path forward to help improve the efficiency and effectiveness of one of the nation’s most important re- sources 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 ix

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x PREFACE 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 in- dividuals 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

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Contents PREFACE ix SUMMARY 1 1 INTRODUCTION 15 Scope of Work and Study Process, 17 Clinical and Translational Research, 19 Overview of the CTSA Program, 22 Organization of the Report, 30 References, 30 2 A VISION FOR THE CTSA PROGRAM IN A CHANGING LANDSCAPE 35 The Current U.S. Health Care Research Landscape, 35 An Evolving Clinical and Translational Research Ecosystem, 38 A Vision for the CTSA Program, 45 References, 47 3 LEADERSHIP 53 Leadership Strategies, 53 Structure of the CTSA Program, 63 Collaborations and Partnerships, 68 Individual CTSAs, 77 Evaluation, 81 Communications, 90 Conclusions and Recommendations, 93 References, 96 xi

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xii CONTENTS 4 CROSSCUTTING TOPICS 105 Training and Education, 105 Community Engagement, 116 Child Health Research, 128 References, 133 5 CONCLUSION: OPPORTUNITIES FOR ACTION 143 APPENDIXES A Data Sources and Methods 147 B Committee Biographical Sketches 159