THE LEARNING HEALTHCARE SYSTEM SERIES

ROUNDTABLE ON VALUE & SCIENCE-DRIVEN HEALTH CARE

REDESIGNING THE CLINICAL EFFECTIVENESS RESEARCH PARADIGM

Innovation and Practice-Based Approaches

Workshop Summary

LeighAnne Olsen and J. Michael McGinnis, Editors

INSTITUTE OF MEDICINE
OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS

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THE LEARNING HEALTHCARE SYSTEM SERIES ROUNDTABLE ON VALUE & SCIENCE-DRIVEN HEALTH CARE REDESIGNING THE CLINICAL EFFECTIVENESS RESEARCH PARADIGM Innovation and Practice-Based Approaches Workshop Summary LeighAnne Olsen and J. Michael McGinnis, Editors

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THE NATIONAL ACADEMIES PRESS 500 Fifth Street, N.W. 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 the Agency for Healthcare Research and Quality, America’s Health Insurance Plans, AstraZeneca, Blue Shield of California Foundation, Burroughs Wellcome Fund, California Health Care Foundation, Centers for Medicare & Medicaid Services, Charina Endowment Fund, Department of Veterans Affairs, Food and Drug Admin- istration, Gordon and Betty Moore Foundation, Johnson & Johnson, sanofi-aventis, and Stryker. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the authors and do not necessarily reflect the view of the organizations or agencies that provided support for this project. International Standard Book Number 13: 978-0-309-11988-7 International Standard Book Number 10: 0-309-11988-X Additional copies of this report are available from the National Academies Press, 500 Fifth Street, N.W., Lockbox 285, Washington, DC 20055; (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area); Internet, http://www.nap.edu. For more information about the Institute of Medicine, visit the IOM home page at: www. iom.edu. Copyright 2010 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). 2010. Redesigning the Clinical Effective- ness Research Paradigm: Innovation and Practice-Based Approaches: Workshop Summary. Washington, DC: The National Academies Press.

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“Knowing is not enough; we must apply. Willing is not enough; we must do.” — Goethe Advising the Nation. Improving Health.

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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 Acad- emy 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 engineer- ing programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Charles M. Vest is presi- dent 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 Insti- tute 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. Charles M. Vest are chair and vice chair, respectively, of the National Research Council. www.national-academies.org

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ROUNDTABLE ON VALUE & SCIENCE-DRIVEN HEALTH CARE1 Denis A. Cortese (Chair), Emeritus President and Chief Executive Officer, Mayo Clinic; Foundation Professor, ASU David Blumenthal, National Coordinator, Office of the National Coordinator for Health IT (ex officio) Bruce G. Bodaken, Chairman, President, and Chief Executive Officer, Blue Shield of California David R. Brennan, Chief Executive Officer, AstraZeneca PLC Paul Chew, Chief Science Officer and CMO, sanofi-aventis U.S., Inc. Carolyn M. Clancy, Director, Agency for Healthcare Research and Quality (ex officio) Francis Collins, Director, National Institutes of Health (designee: Susan Shurin) (ex officio) Michael J. Critelli, Former Executive Chairman, Pitney Bowes, Inc. Helen Darling, President, National Business Group on Health Thomas R. Frieden, Director, Centers for Disease Control and Prevention (ex officio) Gary L. Gottlieb, President and CEO, Partners HealthCare System James A. Guest, President, Consumers Union George C. Halvorson, Chairman and Chief Executive Officer, Kaiser Permanente Margaret A. Hamburg, Commissioner, Food and Drug Administration (ex officio) Carmen Hooker Odom, President, Milbank Memorial Fund Ardis Hoven, Professor of Medicine, University of Kentucky; Chair-elect, American Medical Association Brent James, Chief Quality Officer and Executive Director, Institute for Health Care Delivery Research, Intermountain Healthcare Michael M. E. Johns, Chancellor, Emory University Craig Jones, Director, Vermont Blueprint for Health Cato T. Laurencin, Vice President for Health Affairs, Dean of the School of Medicine, University of Connecticut Stephen P. MacMillan, President and Chief Executive Officer, Stryker Mark B. McClellan, Director, Engelberg Center for Healthcare Reform, The Brookings Institution Sheri S. McCoy, Worldwide Chairman, Johnson & Johnson Pharmaceuticals Group 1 Formerly the Roundtable on Evidence-Based Medicine. IOM forums and roundtables do not issue, review, or approve individual documents. The responsibility for the published workshop summary rests with the workshop rapporteur and the institution. v

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Mary D. Naylor, Professor and Director of Center for Transitions in Health, University of Pennsylvania Peter Neupert, Corporate Vice President, Health Solutions Group, Microsoft Corporation Nancy H. Nielsen, Past President, American Medical Association William D. Novelli, Former CEO, AARP; Professor, Georgetown University Jonathan B. Perlin, Chief Medical Officer and President, Clinical Services, HCA, Inc. Robert A. Petzel, Under Secretary, Veterans Health Administration (designee: Joel Kupersmith) (ex officio) Richard Platt, Professor and Chair, Harvard Medical School and Harvard Pilgrim Health Care John C. Rother, Group Executive Officer, AARP John W. Rowe, Professor, Mailman School of Public Health, Columbia University Mark D. Smith, President and CEO, California HealthCare Foundation Reed D. Tuckson, Executive VP and Chief of Medical Affairs, UnitedHealth Group Frances M. Visco, President, National Breast Cancer Coalition Administrator, Centers for Medicare & Medicaid Services (ex officio) Assistant Secretary for Health Affairs, Department of Defense (ex officio) Workshop Planning Committee Robert M. Califf, Duke Clinical Research Institute, Duke University Lynn Etheredge, George Washington University Kim Gilchrist, AstraZeneca LP Bryan Luce, United Biosource Corporation Jonathan Perlin, HCA, Inc. Richard Platt, Harvard Medical School and Harvard Pilgrim Roundtable Staff Christie Bell, Financial Associate Patrick Burke, Financial Associate (through December 2009) Andrea Cohen, Financial Associate (through December 2008) Kiran Gupta, Research Assistant J. Michael McGinnis, Senior Scholar and Executive Director LeighAnne Olsen, Program Officer Daniel O’Neill, Research Associate (through January 2009) Kate Sharaf, Fellow (through November 2008) vi

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Ruth Strommen, Intern Kate Vasconi, Program Assistant Pierre Yong, Program Officer Allen Zheng, Intern Catherine Zweig, Senior Program Assistant vii

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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 process. We wish to thank the following individuals for their review of this report: David Atkins, Department of Veterans Affairs Health Services Michael S. Lauer, National Institutes of Health Frank W. Rockhold, GlaxoSmithKline Brian L. Strom, University of Pennsylvania School of Medicine Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the final draft of the report before its release. The review of this report was overseen by Richard E. Marshall, Harvard Vanguard Medical Associates. 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. ix

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Institute of Medicine Roundtable on Value & Science-Driven Health Care Charter And Vision Statement The Institute of Medicine’s Roundtable on Value & Science-Driven Health Care has been convened to help transform the way evidence on clinical effec- tiveness is generated and used to improve health and health care. Participants have set a goal that, by the year 2020, 90 percent of clinical decisions will be supported by accurate, timely, and up-to-date clinical information, and will reflect the best available evidence. Roundtable members work with their col- leagues to identify the issues not being adequately addressed, the nature of the barriers and possible solutions, and the priorities for action, and marshal the resources of the sectors represented on the Roundtable to work for sustained public-private cooperation for change. ****************************************** The Institute of Medicine’s Roundtable on Value & Science-Driven Health Care has been convened to help transform the way evidence on clinical effec- tiveness is generated and used to improve health and health care. We seek the development of a learning healthcare system that is designed to generate and apply the best evidence for the collaborative healthcare choices of each patient and provider; to drive the process of discovery as a natural outgrowth of patient care, and to ensure innovation, quality, safety, and value in health care. Vision: Our vision is for a healthcare system that draws on the best evidence to provide the care most appropriate to each patient, emphasizes prevention and health promotion, delivers the most value, adds to learning throughout the delivery of care, and leads to improvements in the nation’s health. Goal: By the year 2020, 90 percent of clinical decisions will be supported by accurate, timely, and up-to-date clinical information, and will reflect the best available evidence. We feel that this presents a tangible focus for prog- ress toward our vision, that Americans ought to expect at least this level of performance, that it should be feasible with existing resources and emerging tools, and that measures can be developed to track and stimulate progress. Context: As unprecedented developments in the diagnosis, treatment, and long-term management of disease bring Americans closer than ever to the promise of personalized health care, we are faced with similarly unprecedented challenges to identify and deliver the care most appropriate for individual needs and conditions. Care that is important is often not delivered. Care that is delivered is often not important. In part, this is due to our failure to apply the evidence we have about the medical care that is most effective—a failure related to shortfalls in provider knowledge and accountability, inadequate care coordination and support, lack of insurance, poorly aligned payment incen- tives, and misplaced patient expectations. Increasingly, it is also a result of our xi

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limited capacity for timely generation of evidence on the relative effectiveness, efficiency, and safety of available and emerging interventions. Improving the value of the return on our healthcare investment is a vital imperative that will require much greater capacity to evaluate high priority clinical interventions, stronger links between clinical research and practice, and reorientation of the incentives to apply new insights. We must quicken our efforts to position evi- dence development and application as natural outgrowths of clinical care—to foster health care that learns. Approach: The Institute of Medicine’s Roundtable on Value & Science- Driven Health Care serves as a forum to facilitate the collaborative assessment and action around issues central to achieving the vision and goal stated. The challenges are myriad and include issues that must be addressed to improve evidence development, evidence application, and the capacity to advance progress on both dimensions. To address these challenges, as leaders in their fields, Roundtable members work with their colleagues to identify the issues not being adequately addressed, the nature of the barriers and possible solu- tions, and the priorities for action, and marshal the resources of the sectors represented on the Roundtable to work for sustained public–private coopera- tion for change. Activities include collaborative exploration of new and expedited approaches to assessing the effectiveness of diagnostic and treatment inter- ventions, better use of the patient care experience to generate evidence on effectiveness and efficacy of care, identification of assessment priorities, and communication strategies to enhance provider and patient understanding and support for interventions proven to work best and deliver value in health care. Core concepts and principles: For the purpose of the Roundtable activities, we define value and science-driven health care broadly to mean that to the greatest extent possible, the decisions that shape the health and health care of Americans—by patients, providers, payers, and policy makers alike—will be grounded on a reliable evidence base, will account appropriately for individual variation in patient needs, and will support the generation of new insights on clinical effectiveness. Evidence is generally considered to be information from clinical experience that has met some established test of validity, and the appropriate standard is determined according to the requirements of the intervention and clinical circumstance. Processes that involve the development and use of evidence should be accessible and transparent to all stakeholders. A common commitment to certain principles and priorities guides the activities of the Roundtable and its members, including the commitment to the right health care for each person; putting the best evidence into practice; establishing the effectiveness, efficiency, and safety of medical care deliv- ered; building constant measurement into our healthcare investments; the establishment of healthcare data as a public good; shared responsibility dis- tributed equitably across stakeholders, both public and private; collaborative stakeholder involvement in priority setting; transparency in the execution of activities and reporting of results; and subjugation of individual political or stakeholder perspectives in favor of the common good. xii

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Foreword Recent scientific and technological advances have accelerated our understanding of the causes of disease development and progression, and resulted in innovative treatments and therapies. Ongoing work to elucidate the effects of individual genetic variation on patient outcomes suggests the rapid pace of discovery in the biomedical sciences will only acceler- ate. However, these advances belie an important and increasing shortfall between the expansion in therapy and treatment options and knowledge about how these interventions might be applied appropriately to individual patients. The impressive gains made in Americans’ health over the past decades provide only a preview of what might be possible when data on treatment effects and patient outcomes are systematically captured and used to evaluate their effectiveness. Needed for progress are advances as dramatic as those experienced in biomedicine in our approach to assessing clinical effectiveness. The establishment in the 1970s of the randomized controlled trial as the Food and Drug Administration’s standard in its judgments about efficacy brought greater rigor, through systematic evaluation, to the field of medicine and to the introduction of new interventions. However, in the emerging era of tailored treatments and rapidly evolving practice, ensur- ing the translation of scientific discovery into improved health outcomes requires a new approach to clinical evaluation. A paradigm that supports a continual learning process about what works best for individual patients will not only take advantage of the rigor of trials, but also incorporate other methods that might bring insights relevant to clinical care and endeavor to match the right method to the question at hand. xiii

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xiv FOREWORD The Institute of Medicine Roundtable on Value & Science-Driven Health Care’s vision for a learning healthcare system, in which evidence is applied and generated as a natural course of care, is premised on the development of a research capacity that is structured to provide timely and accurate evidence relevant to the clinical decisions faced by patients and providers. Convened in 2006, the Roundtable has considered key opportunities to transform how evidence is generated and applied to improve health and health care. Therefore, on December 12–13, 2007, as part of the Roundta- ble’s Learning Healthcare System series of workshops, clinical researchers, academics, and policy makers gathered for the workshop Redesigning the Clinical Effectiveness Research Paradigm: Innovation and Practice-Based Approaches. Participants explored cutting-edge research designs and meth- ods and discussed strategies for development of a research paradigm to better accommodate the diverse array of emerging data resources, study designs, tools, and techniques. Presentations and discussions are summa- rized in this volume. I thank the members of the Roundtable and other workshop partici- pants for their leadership and dedication in addressing the challenging issues needed to advance progress toward a healthcare system that seeks to promote innovation, safety, efficiency, and value. I also thank members of the Roundtable staff for their efforts to coordinate and facilitate Roundtable activities, as well as the sponsors, who make this work possible: the Agency for Healthcare Research and Quality, America’s Health Insurance Plans, AstraZeneca, Blue Shield of California Foundation, Burroughs Wellcome Fund, California Health Care Foundation, Centers for Medicare & Medicaid Services, Charina Endowment Fund, Department of Veterans Affairs, Food and Drug Administration, Gordon and Betty Moore Foundation, Johnson & Johnson, sanofi-aventis, and Stryker. Harvey V. Fineberg, M.D., Ph.D. President, Institute of Medicine

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Preface As we move toward a healthcare system in which interventions and treatment strategies are increasingly tailored to individual genetic variation, preferences, and circumstances, a similar shift is needed in the way care is delivered and evidence is developed. Endeavoring to provide the treatment most appropriate to each individual requires a commitment to develop- ing the systems of care, capturing the data, and advancing the methods of analysis needed to generate evidence on clinical effectiveness. These efforts will enable researchers to build on the safety and efficacy determinations developed in the approval process and to better assess intervention effects in real- world patients and practice environments. The Institute of Medicine’s (IOM’s) Roundtable on Value & Science- Driven Health Care envisions the development of such a system that “draws on best evidence to provide the care most appropriate to each patient, emphasizes prevention and health promotion, delivers the most value, adds to learning throughout the delivery of care, and leads to improve- ments in the nation’s health.” To better understand how key healthcare stakeholders—patients, providers, insurers, regulators, and researchers— might help to initiate the work needed to realize this vision, the Roundtable has developed the Learning Healthcare System series of meetings and work- shops. The Roundtable’s inaugural publication, The Learning Healthcare System, provides an overview of the key barriers and opportunities for advancing progress toward the Roundtable’s goal that by 2020, 90 percent of clinical decisions will be supported by accurate, timely, and up-to-date clinical information and will reflect the best available evidence. xv

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xvi PREFACE Chief among the needs identified is the development of a new clinical research paradigm—oriented toward the creation of a more practical and reliable means to gather and assess evidence of clinical effectiveness. Many have suggested that current approaches to developing clinical evidence are inadequate for the need and, given the rapid pace of discovery and techno- logical innovation, may soon become irrelevant. To explore the opportu- nities presented by new and emerging research methods that can support the development of insights relevant to clinical practice, by taking better advantage of vastly larger databases and other sources of electronically captured data such as electronic health records, the Roundtable convened a workshop titled Redesigning the Clinical Effectiveness Research Paradigm: Innovation and Practice-Based Approaches. This publication, the fifth in the Learning Healthcare System series, summarizes the presentations and discussions of that workshop, which explored the methods, data resources, tools, and techniques that might be deployed collectively as a new genera- tion of studies and serve as foundational elements of a learning healthcare system. Numerous themes emerged from the workshop discussion on how research tools and methods can be engaged to better address many of the current challenges in clinical effectiveness research related to time and cost constraints, the trade-offs between internal and external validity of study designs, and the need to accommodate for genetic variation among research subjects. An overarching focus over the 2 days of presentations was on the strategies and implications of moving from a paradigm centered on a hierarchy of evidence toward a model of continuous learning and more appropriately matching study designs with circumstances and needs. Also identified by workshop participants were a number of cross-sector follow-up actions proposed for possible Roundtable attention, including greater support for researchers at the cutting edge of methods development; opportunities to bring greater clarity to the field on what constitutes state- of-the-art research methods and how these studies are reported and applied; and help to spur action around the technical, economic, and cultural issues needed to better support the collection of health data at the point of care and apply these data to clinical effectiveness research. We would like to acknowledge those individuals and organizations who gave valuable time toward the development of this workshop sum- mary. In particular, we acknowledge the contributors to this volume for their presence at the workshop and/or their efforts to further develop their presentations into the manuscripts in this summary. We also would like to acknowledge those who provided counsel by serving on the planning committee for this workshop, including Robert Califf (Duke University), Lynn Etheredge (George Washington University), Kim Gilchrist (Astra- Zeneca LP), Bryan Luce (United BioSource Corporation), Jonathan Perlin

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xvii PREFACE (HCA, Inc.), and Richard Platt (Harvard University).1 A number of IOM staff were instrumental in coordinating the 2-day workshop in December 2007, including Sarah Bronko and Kristina Shulkin. Roundtable staff, including Katherine Bothner, Alex Goolsby, LeighAnne Olsen, and Daniel O’Neill, helped to translate the workshop proceedings and discussion into this summary. Stephen Pelletier and Laura Penny also contributed sub- stantially to publication development. We would also like to thank Lara Andersen, Michele de la Menardiere, Bronwyn Schrecker, Vilija Teel, and Jackie Turner for helping to coordinate the various aspects of review, pro- duction, and publication. Workshop discussions captured in this publication provide important perspectives for the development of our research enterprise as electronic health data, statistical tools, and innovative study designs expand our abilities. Full application of this capacity will amount to nothing less than a dynamic new clinical research paradigm. The pace of that progress will depend on our success in achieving stronger incentives for stakeholders to embrace the use of practice-based evidence and in fostering a research com- munity galvanized and organized for change. Denis A. Cortese Chair, Roundtable on Value & Science-Driven Health Care J. Michael McGinnis Executive Director, Roundtable on Value & Science-Driven Health Care 1 IOM planning committees are solely responsible for organizing the workshop, identifying topics, and choosing speakers. The responsibility for the published workshop summary rests with the workshop rapporteur and the institution.

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Contents Summary 1 1 Evidence Development for Healthcare Decisions: Improving Timeliness, Reliability, and Efficiency 51 Introduction, 51 EBM and Clinical Effectiveness Research, 52 Perspectives on Clinical Effectiveness Research, 60 Clinical Effectiveness Research: Past, Present, and Future, Harvey V. Fineberg, 60 The Path to Research That Meets Evidence Needs, Carolyn M. Clancy, 67 2 Cases in Point: Learning from Experience 87 Introduction, 87 Hormone Replacement Therapy, JoAnn E. Manson, 89 Drug-Eluting Coronary Stents, Ashley B. Boam, 104 Bariatric Surgery, David R. Flum, 115 Antipsychotic Therapeutics, Philip S. Wang, M. Alan Brookhart, Soko Setoguchi, Christine Ulbricht, and Sebastian Schneeweiss, 125 Cancer Screening, Peter B. Bach, 134 3 Taking Advantage of New Tools and Techniques 155 Introduction, 155 Innovative Approaches to Clinical Trials, Robert M. Califf, 157 xix

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xx CONTENTS Innovative Analytic Tools for Large Clinical and Administrative Databases, Sebastian Schneeweiss, 167 Adaptive and Bayesian Approaches to Study Design, Donald A. Berry and Frank T. McGraw, 174 Simulation and Predictive Modeling, Mark S. Roberts and David M. Eddy, 180 Emerging Genomic Information, Teri A. Manolio, 189 4 Organizing and Improving Data Utility 221 Introduction, 221 The Electronic Health Record and Care Reengineering: Performance Improvement Redefined, Ronald A. Paulus, Walter F. Stewart, Albert Bothe, Jr., Seth Frazier, Nirav R. Shah, and Mark J. Selna, 222 Administrative Databases in Clinical Effectiveness Research, Alexander M. Walker, 237 Clinical Effectiveness Research: The Promise of Registries, Alan J. Moskowitz and Annetine C. Gelijns, 242 Distributed Data Networks, Richard Platt, 253 5 Moving to the Next Generation of Studies 267 Introduction, 267 Large Data Streams and the Power of Numbers, Sharon-Lise T. Normand, 269 Observational Studies, Wayne A. Ray, 276 Enhancing the Evidence to Improve Practice: Experimental and Hybrid Studies, A. John Rush, 281 Accommodating Genetic Variation as a Standard Feature of Clinical Research, Isaac Kohane, 294 Phased Introduction and Payment for Interventions Under Protocol, Wade M. Aubry, 299 Research Networks, Eric B. Larson and Sarah Greene, 307 6 Aligning Policy with Research Opportunities 323 Introduction, 323 Course-of-Care Data, Greg Pawlson, 325 Pharmaceutical Industry Data, Peter K. Honig, 331 Regulatory Requirements and Data Generation, Mark B. McClellan, 334 Ensuring Optimal Use of Data Generated by Public Investment, J. Sanford Schwartz, 339

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xxi CONTENTS Building the Research Infrastructure, Alan M. Krensky, 343 Engaging Consumers, Kathy Hudson, Rick E. Borchelt, and Shawna Williams, 353 7 Organizing the Research Community for Change 363 Introduction, 363 Increasing Knowledge from Practice-Based Research, 364 Opportunities for Action (Panel Discussion), Mark B. McClellan, Alan M. Krensky, Garry Neil, John Niederhuber, and Lewis Sandy, 365 Common Themes, 370 Issues for Possible Roundtable Follow-Up, 374 Appendixes A Workshop Agenda 381 B Biographical Sketches of Participants 387 C Workshop Attendee List 409

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