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Suggested Citation:"Front Matter." Institute of Medicine. 2010. Transforming Clinical Research in the United States: Challenges and Opportunities: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12900.
×

FORUM ON DRUG DISCOVERY, DEVELOPMENT, AND TRANSLATION

TRANSFORMING CLINICAL RESEARCH IN THE UNITED STATES

CHALLENGES AND OPPORTUNITIES

WORKSHOP SUMMARY

Rebecca A. English, Yeonwoo Lebovitz, and Robert B. Giffin, Rapporteurs

Forum on Drug Discovery, Development, and Translation

Board on Health Sciences Policy

INSTITUTE OF MEDICINE
OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS

Washington, D.C.
www.nap.edu

Suggested Citation:"Front Matter." Institute of Medicine. 2010. Transforming Clinical Research in the United States: Challenges and Opportunities: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12900.
×

THE NATIONAL ACADEMIES PRESS
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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 Department of Health and Human Services (Contract Nos. N01-OD-4-2139 and 223001003T), the American Diabetes Association, the American Society for Microbiology, Amgen Inc., the Association of American Medical Colleges, AstraZeneca Pharmaceuticals, the Burroughs-Wellcome Fund, Celtic Therapeutics, LLLP, the Critical Path Institute, the Doris Duke Charitable Foundation, Eli Lilly & Co., Entelos Inc., Genentech, GlaxoSmithKline, Johnson & Johnson, Novartis Pharmaceuticals Corporation, and Pfizer Inc. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the view of the organizations or agencies that provided support for this project.

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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. Transforming Clinical Research in the United States: Challenges and Opportunities: Workshop Summary. Washington, DC: The National Academies Press.

Suggested Citation:"Front Matter." Institute of Medicine. 2010. Transforming Clinical Research in the United States: Challenges and Opportunities: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12900.
×

“Knowing is not enough; we must apply.

Willing is not enough; we must do.”

—Goethe

INSTITUTE OF MEDICINE
OF THE NATIONAL ACADEMIES


Advising the Nation. Improving Health.

Suggested Citation:"Front Matter." Institute of Medicine. 2010. Transforming Clinical Research in the United States: Challenges and Opportunities: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12900.
×

THE NATIONAL ACADEMIES

Advisers to the Nation on Science, Engineering, and Medicine


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. Charles M. Vest 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. Charles M. Vest are chair and vice chair, respectively, of the National Research Council.


www.national-academies.org

Suggested Citation:"Front Matter." Institute of Medicine. 2010. Transforming Clinical Research in the United States: Challenges and Opportunities: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12900.
×

PLANNING COMMITTEE FOR THE WORKSHOP ON TRANSFORMING CLINICAL RESEARCH IN THE UNITED STATES1

BARBARA ALVING,

National Center for Research Resources, Maryland

LINDA BRADY,

National Institute of Mental Health, Maryland

ROBERT CALIFF,

Duke University Medical Center, North Carolina

SCOTT CAMPBELL,

American Diabetes Association, Virginia

GAIL H. CASSELL,

Eli Lilly and Company, Indiana

JAMES H. DOROSHOW,

National Cancer Institute, Maryland

JEFFREY M. DRAZEN,

New England Journal of Medicine, Massachusetts

GARRET A. FITZGERALD,

University of Pennsylvania School of Medicine

PETER K. HONIG,

Merck Research Laboratories (retired), Pennsylvania

RONALD L. KRALL,

GlaxoSmithKline (retired), Pennsylvania

MUSA MAYER,

AdvancedBC.org, New York

IRENA TARTAKOVSKY,

Association of American Medical Colleges, Washington, DC

JORGE A. TAVEL,

National Institute of Allergy and Infectious Diseases, Maryland

IOM Staff

ANNE B. CLAIBORNE, Director (as of April 5, 2010)

ROBERT B. GIFFIN, Director (until February 26, 2010)

REBECCA A. ENGLISH, Research Associate

YEONWOO LEBOVITZ, Program Associate

GENEA S. VINCENT, Senior Program Assistant

RONA BRIERE, Consulting Editor

1

The planning committee’s role was limited to planning the workshop, and the workshop summary has been prepared by the workshop rapporteurs as a factual summary of what occurred at the workshop.

Suggested Citation:"Front Matter." Institute of Medicine. 2010. Transforming Clinical Research in the United States: Challenges and Opportunities: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12900.
×

FORUM ON DRUG DISCOVERY, DEVELOPMENT, AND TRANSLATION1

Gail H. Cassell (Co-Chair),

Eli Lilly and Company, Indiana

Jeffrey M. Drazen (Co-Chair),

New England Journal of Medicine, Massachusetts

Barbara Alving,

National Center for Research Resources, Maryland

Leslie Z. Benet,

University of California–San Francisco

Ann Bonham,

Association of American Medical Colleges, Washington, DC

Linda Brady,

National Institute of Mental Health, Maryland

Robert M. Califf,

Duke University Medical Center, North Carolina

Scott Campbell,

Foundation for the National Institutes of Health, Maryland

Peter B. Corr,

Celtic Therapeutics Management Company, LLP, New York

James H. Doroshow,

National Cancer Institute, Maryland

Paul R. Eisenberg,

Amgen, Inc., California

Gary L. Filerman,

ATLAS Research, Washington, DC

Garret A. FitzGerald,

University of Pennsylvania School of Medicine

Elaine K. Gallin,

The Doris Duke Charitable Foundation, New York

Steven K. Galson,

Science Applications International Corporation, Virginia

Harry B. Greenberg,

Stanford University School of Medicine, California

Stephen Groft,

National Institutes of Health, Maryland

Peter K. Honig,

AstraZeneca Pharmaceuticals, Delaware

Annalisa Jenkins,

Bristol-Myers Squibb, New Jersey

Michael Katz,

March of Dimes Foundation, New York

Jack D. Keene,

Duke University Medical Center, North Carolina

Ronald L. Krall,

GlaxoSmithKline (retired), Pennsylvania

Freda Lewis-Hall,

Pfizer, Inc., New York

William Matthew,

National Institute of Neurological Disorders and Stroke, Maryland

Mark B. McClellan,

Brookings Institution, Washington, DC

Carol Mimura,

University of California-Berkeley

John Orloff,

Novartis Pharmaceuticals Corporation, New Jersey

Amy Patterson,

National Institutes of Health, Maryland

Janet Shoemaker,

American Society for Microbiology, Washington, DC

Nancy S. Sung,

Burroughs Wellcome Fund, North Carolina

Jorge A. Tavel,

National Institute of Allergy and Infectious Diseases, Maryland

Janet Tobias,

Ikana Media, New York

Joanne Waldstreicher,

Johnson & Johnson, New Jersey

Janet Woodcock,

U.S. Food and Drug Administration, Maryland

Raymond Woosley,

The Critical Path Institute, Arizona

1

IOM forums and roundtables do not issue, review, or approve individual documents. The responsibility for the published workshop summary rests with the workshop rapporteurs and the institution.

Suggested Citation:"Front Matter." Institute of Medicine. 2010. Transforming Clinical Research in the United States: Challenges and Opportunities: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12900.
×

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:

Timothy Coetzee, Fast Forward, LLC, National Multiple Sclerosis Society

Marlene E. Haffner, Haffner Associates, LLC

Steven E. Kahn, Division of Metabolism, Endocrinology, and Nutrition, Seattle VA Puget Sound Health Care System

Michael S. Lauer, Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, National Institutes of Health

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 Alastair J.J. Wood, Symphony Capital, LLC. 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 authors and the institution.

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Suggested Citation:"Front Matter." Institute of Medicine. 2010. Transforming Clinical Research in the United States: Challenges and Opportunities: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12900.
×

Preface

Clinical trials are the way the medical field tests whether a new therapeutic product performs as expected and actually makes a difference in treating disease. Hundreds of innovative therapies are generated in laboratories, but few survive early development to reach the point of human testing. Clinical trials in patients suffering from a specific condition represent the crucial link between scientific discovery and medical utility.

To plan and execute a clinical trial today can take years and cost hundreds of millions of dollars. In the past, the United States was considered the best place to conduct clinical trials because of the right mix of clinical and scientific expertise and an understanding of the research process. However, many believe that the clinical research enterprise in the United States has failed to keep pace with that in the rest of the world because of this time and cost burden. To evaluate the state of clinical research in the United States and identify strategies for enhancing the effectiveness and efficiency of clinical trials, the Institute of Medicine’s Forum on Drug Discovery, Development, and Translation convened a public workshop on October 7–8, 2009, titled Transforming Clinical Research in the United States. Clinical trial experts from academic research centers, pharmaceutical companies, contract research organizations, government, nonprofit research networks, and patient advocacy groups came together to discuss their clinical trial successes and failures, the challenges they face in conducting clinical research, and strategies for improving the efficiency of clinical trials while maintaining the highest standards for the data generated.

The intent of the workshop was to engage stakeholders in an honest discussion of the state of clinical trials today and to gain an understanding

Suggested Citation:"Front Matter." Institute of Medicine. 2010. Transforming Clinical Research in the United States: Challenges and Opportunities: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12900.
×

of what has and has not worked in planning and executing trials. The workshop was focused on four disease areas: cardiovascular disease, depression, cancer, and diabetes. Although “clinical research” is a generic term, a clinical trial in breast cancer, with 5-, 10-, or 15-year outcomes, is quite different from a clinical trial in cardiovascular disease, where the outcome of interest may occur in a month or less. The disease being studied also affects the kind of patients needed and how they are recruited and retained. Gaining an appreciation of the differences in clinical trials by disease helped generate ideas for improving the clinical research enterprise as a whole.

This workshop is part of a broader initiative of the Forum addressing different aspects of clinical research. Future Forum plans include the following: further examining regulatory, administrative, and structural barriers to the effective conduct of clinical research; developing a vision for a stable, continuously funded clinical research infrastructure in the United States; and considering strategies and collaborative activities to facilitate more robust public engagement in the clinical research enterprise.

As the starting point for the Forum’s work in the area of clinical research, it is our hope that this workshop summary will serve as a resource for all organizations and individuals seeking a greater understanding of how the clinical research enterprise works and how it can improve. The workshop showcased the best examples from clinical research conducted to date and developed novel ideas for organizing and conducting clinical trials. Ultimately, as the health care system moves forward, we hope our work can serve as a source of information and inspiration to those involved in clinical research as sponsors, investigators, clinicians, patients, and policy makers.


Jeffrey M. Drazen, Co-Chair

Forum on Drug Discovery, Development, and Translation

Suggested Citation:"Front Matter." Institute of Medicine. 2010. Transforming Clinical Research in the United States: Challenges and Opportunities: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12900.
×
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Suggested Citation:"Front Matter." Institute of Medicine. 2010. Transforming Clinical Research in the United States: Challenges and Opportunities: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12900.
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Tables, Figures, and Boxes

TABLES

3-1

 

Global Research Costs: Relative Cost Indexes of Payments to Clinical Trial Sites,

 

25

3-2

 

Breakdown of the Costs for a Large, Global Clinical Trial (14,000 patients, 300 sites),

 

26

7-1

 

Structure of Study Centers for a Government-Sponsored Randomized Controlled Trial (Diabetes Prevention Program [DPP]) and an Industry-Sponsored Randomized Controlled Trial (A Diabetes Progression Outcomes Trial [ADOPT]),

 

80

FIGURES

2-1

 

Timeline reflecting the number of clinical trials registered on clinicaltrials. gov and regulatory changes affecting the database registration from 2001 to 2009,

 

10

2-2

 

Percentage of the 10,974 ongoing clinical trials and 2.8 million study subjects being sought by intervention being tested,

 

13

2-3

 

Number of the 8,386 clinical trials involving FDA-regulated products and 1.9 million study subjects being sought for these trials by phase of research,

 

14

2-4

 

Number of the 10,974 ongoing clinical trials and 2.8 million study subjects being sought by disease being studied,

 

14

Suggested Citation:"Front Matter." Institute of Medicine. 2010. Transforming Clinical Research in the United States: Challenges and Opportunities: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12900.
×

2-5

 

The proportion of clinical investigators from North America has decreased since 1997, while the proportion of investigators from Western Europe and the rest of the world has increased,

 

16

3-1

 

While the number of senior NIAID/NIH tenured investigators is relatively stable, the number of NIAID/NIH tenure-track principal investigators is decreasing,

 

29

4-1

 

Classification system for the spectrum of acute coronary syndromes that helps practitioners identify a study population more easily,

 

40

4-2

 

Timeline for the NIH-sponsored Occluded Artery Trial (OAT),

 

47

Figure in Box 5-1

 

STAR*D clinical trial results: remission rates by treatment level (monotherapy or combination treatment),

 

61

7-1

 

Study management structure for a government-sponsored randomized controlled trial (Diabetes Prevention Program [DPP]) and an industry-sponsored randomized controlled trial (A Diabetes Progression Outcomes Trial [ADOPT]),

 

79

7-2

 

Patient recruitment rates for four type 1 diabetes trials,

 

82

8-1

 

CTSAs include 46 institutions in 26 states,

 

89

8-2

 

Typical NIH clinical trial network with academic health center sites surrounding the hub of a data coordinating center,

 

93

8-3

 

A vision of an integrated clinical research system linking existing networks (patients, physicians, and scientists) to form communities of research and conduct clinical trials more effectively,

 

93

BOXES

4-1

 

Case Study: Acute Decompensated Heart Failure and Acute Myocardial Infarction,

 

40

5-1

 

Case Study: STAR*D,

 

60

6-1

 

Current Initiatives of NCI’s Clinical Trials Working Group to Optimize the Clinical Trials System,

 

68

Suggested Citation:"Front Matter." Institute of Medicine. 2010. Transforming Clinical Research in the United States: Challenges and Opportunities: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12900.
×

Acronyms

ACS acute coronary syndromes

ADA American Diabetes Association

ADOPT A Diabetes Outcome Progression Trial

AHA American Heart Association

AHRQ Agency for Healthcare Research and Quality

ARO academic research organization

ARRA American Recovery and Reinvestment Act of 2009

caBIG Cancer Biomedical Informatics Grid

CDER Center for Drug Evaluation and Research

CEC clinical events committee

CER comparative effectiveness research

CMS Centers for Medicare and Medicaid Services

CNS central nervous system

CRF case report form

CRN clinical research network

CRO contract research organization

CTA clinical trial agreement

CTEP Cancer Therapy Evaluation Program

CTSA Clinical and Translational Science Awards

CTTI Clinical Trials Transformation Initiative

DBSA Depression and Bipolar Support Alliance

DCRI Duke Clinical Research Institute

DMC data monitoring committee

Suggested Citation:"Front Matter." Institute of Medicine. 2010. Transforming Clinical Research in the United States: Challenges and Opportunities: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12900.
×

DPP diabetes prevention program

DSMB data safety monitoring board

ECG electrocardiogram

ECOG Eastern Cooperative Oncology Group

FDA U.S. Food and Drug Administration

FDAAA Food and Drug Administration Amendments Act of 2007

FDAMA Food and Drug Administration Modernization Act of 1997

HAM-D Hamilton Depression Rating Scale

HHS U.S. Department of Health and Human Services

HIPAA Health Information Portability and Accountability Act

ICMJE International Committee of Medical Journal Editors

IECRN Inventory and Evaluation of Clinical Research Networks

IOM Institute of Medicine

IRB Institutional Review Board

ISIS International Study of Infarct Survival

JDRF Juvenile Diabetes Research Foundation

MI myocardial infarction

MTA material transfer agreement

NCI National Cancer Institute

NCRR National Center for Research Resources

NDA New Drug Application

NHLBI National Heart, Lung, and Blood Institute

NIA National Institute on Aging

NIAID National Institute of Allergy and Infectious Diseases

NIDDK National Institute of Diabetes and Digestive and Kidney Diseases

NIH National Institutes of Health

NIMH National Institute of Mental Health

NLM National Library of Medicine

OAT occluded artery trial

OPEN oncology patient enrollment network

PBRN Practice-Based Research Network

PCI percutaneous intervention

Page xvii Cite
Suggested Citation:"Front Matter." Institute of Medicine. 2010. Transforming Clinical Research in the United States: Challenges and Opportunities: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12900.
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PCORI Patient-Centered Outcomes Research Institute

PhRMA Pharmaceutical Research and Manufacturers of America

PI principal investigator

RCT randomized controlled trial

RFA Request for Applications

SSRI selective serotonin reuptake inhibitor

STAR*D Sequenced Treatment Alternatives to Relieve Depression

STEMI ST segment elevation myocardial infarction

TIMI Thrombolysis in Myocardial Infarction Study Group

VA U.S. Department of Veterans Affairs

WHO World Health Organization

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An ideal health care system relies on efficiently generating timely, accurate evidence to deliver on its promise of diminishing the divide between clinical practice and research. There are growing indications, however, that the current health care system and the clinical research that guides medical decisions in the United States falls far short of this vision. The process of generating medical evidence through clinical trials in the United States is expensive and lengthy, includes a number of regulatory hurdles, and is based on a limited infrastructure. The link between clinical research and medical progress is also frequently misunderstood or unsupported by both patients and providers.

The focus of clinical research changes as diseases emerge and new treatments create cures for old conditions. As diseases evolve, the ultimate goal remains to speed new and improved medical treatments to patients throughout the world. To keep pace with rapidly changing health care demands, clinical research resources need to be organized and on hand to address the numerous health care questions that continually emerge. Improving the overall capacity of the clinical research enterprise will depend on ensuring that there is an adequate infrastructure in place to support the investigators who conduct research, the patients with real diseases who volunteer to participate in experimental research, and the institutions that organize and carry out the trials.

To address these issues and better understand the current state of clinical research in the United States, the Institute of Medicine's (IOM) Forum on Drug Discovery, Development, and Translation held a 2-day workshop entitled Transforming Clinical Research in the United States. The workshop, summarized in this volume, laid the foundation for a broader initiative of the Forum addressing different aspects of clinical research. Future Forum plans include further examining regulatory, administrative, and structural barriers to the effective conduct of clinical research; developing a vision for a stable, continuously funded clinical research infrastructure in the United States; and considering strategies and collaborative activities to facilitate more robust public engagement in the clinical research enterprise.

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