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Sharing Clinical Research Data: Workshop Summary (2013)

Chapter: Appendix A: Workshop Agenda

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Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2013. Sharing Clinical Research Data: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18267.
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A

Workshop Agenda

Sharing Clinical Research Data: An Institute of Medicine Workshop

October 4–5, 2012

National Academy of Sciences Building, Room 125
2101 Constitution Avenue, NW
Washington, DC 20418

Background:

Pharmaceutical companies, academic institutions, advocacy organizations, and government agencies such as the Food and Drug Administration and the National Institutes of Health have large quantities of clinical research data. Increased data sharing could facilitate scientific and public health advances, among other potential benefits to patients and society. Much of this information, however, is not transparent or shared beyond the data owner. More specifically, study results are not always published and where results are published, they typically only include summary-level data; participant-level data are privately held and rarely shared or revealed publicly.

This workshop will explore the benefits of and barriers to the sharing of clinical research data and will help identify strategies for enhancing the sharing both within and across sectors. To facilitate identification of key issues and potential solutions, the workshop will focus on data resulting from preplanned interventional studies of human subjects. While recognizing the importance of other data sources such as observational

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2013. Sharing Clinical Research Data: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18267.
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studies and electronic health records, this focus was selected to encourage concrete problem-solving discussions over the course of a day-and-a-half– long meeting. Models and projects that involve sharing of other types of data will be considered during the workshop to the extent that these models provide lessons and best practices applicable to sharing preplanned interventional clinical research data.

The workshop is being jointly organized by the Institute of Medicine’s Forum on Drug Discovery, Development, and Translation; Forum on Neuroscience and Nervous System Disorders; National Cancer Policy Forum; and Roundtable on Translating Genomic-Based Research for Health.

Meeting Objectives:

•   Examine the benefits of sharing of clinical research data, and specifically clinical trial data, from all sectors and among these sectors, including, for example:

o   Benefits to the research and development enterprise

o   Benefits to the analysis of safety and efficacy

•   Identify barriers and challenges to sharing clinical research data.

•   Explore strategies to address these barriers and challenges, including the identification of priority actions and “low-hanging fruit” opportunities.

•   Discuss strategies for using these potentially large datasets to facilitate scientific and public health advances.

October 4, 2012
Day One

8:30 a.m.

Opening Remarks

SHARON TERRY, Workshop Chair

President and Chief Executive Officer

Genetic Alliance

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2013. Sharing Clinical Research Data: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18267.
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SESSION I: BENEFITS OF SHARING CLINICAL RESEARCH DATA

Session Objectives:

•   Provide an overview of the benefits of sharing clinical research data, specifically clinical trial data, and discuss advantages and disadvantages of sharing participant- versus summary-level data from individual trials as well as pooling data across multiple studies.

•   Consider examples of scientific success stories that illustrate what can be accomplished when clinical trial data are shared.

8:40 a.m.

Background and Session Objectives

WILLIAM POTTER, Session Co-Chair

Co-Chair Emeritus

Neuroscience Steering Committee

Foundation for the National Institutes of Health (FNIH)

Biomarkers Consortium

DEBORAH ZARIN, Session Co-Chair

Director, ClinicalTrials.gov

National Library of Medicine

National Institutes of Health

8:50 a.m.

Fundamentals and Benefits of Sharing Participant-Level Clinical Trial Data

ELIZABETH LODER

Clinical Epidemiology Editor, BMJ

9:10 a.m.

Pooling Data from Multiple Clinical Trials to Answer Big Questions

ROBERT CALIFF

Director, Duke Translational Medicine Institute

Professor of Medicine

Vice Chancellor for Clinical and Translational Research

Duke University Medical Center

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2013. Sharing Clinical Research Data: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18267.
×

9:30 a.m.

Panel Discussion: Perspectives on the Benefits of Sharing Clinical Trial Data

•   Data sharing—what does it mean from your perspective?

•   Considering the benefits and risks of sharing clinical research data, how extensively should it be shared to maximize new knowledge and ultimately patient benefit?

Panelists

HARLAN KRUMHOLZ

Harold H. Hines, Jr., Professor of Medicine and

Epidemiology and Public Health

Yale University School of Medicine

MYLES AXTON

Editor

Nature Genetics

JESSE BERLIN

Vice President of Epidemiology

Janssen Research & Development, LLC

Panel Moderators

WILLIAM POTTER, Session Co-Chair

Co-Chair Emeritus

Neuroscience Steering Committee

FNIH Biomarkers Consortium

DEBORAH ZARIN, Session Co-Chair

Director, ClinicalTrials.gov

National Library of Medicine

National Institutes of Health

10:30 a.m.

BREAK

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2013. Sharing Clinical Research Data: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18267.
×

SESSION II: DATA-SHARING MODELS: DESIGN, BEST PRACTICES, AND LESSONS LEARNED

Session Objectives:

•   Present examples, best practices, and lessons learned from projects across the continuum of data-sharing opportunities (e.g., rapid publication of participant-level data, increased access to participant-level data for qualified researchers, or maximizing the use of clinical research data that are currently held in centralized locations by requiring sharing or access to subsets of data).

•   Distill best practices and lessons learned that can be applied broadly to new projects to maximize the use of data from individual trials and/or data-pooling initiatives.

10:45 a.m.

Background and Session Objectives

JEFFREY NYE, Session Chair

Vice President

Neuroscience Innovation and Partnership Strategy

Janssen Research & Development, LLC

10:55 a.m.

The Limits of Summary Data Reporting: Lessons from ClinicalTrials.gov

DEBORAH ZARIN

Director, ClinicalTrials.gov

National Library of Medicine

National Institutes of Health

11:10 a.m.

Models That Increase Access and Use of Data from Individual Clinical Trials

The DataSphere Project

CHARLES HUGH-JONES

Vice President, Medical Affairs North America

Sanofi Oncology, on behalf of the Life Sciences

Consortium

CEO Roundtable on Cancer

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2013. Sharing Clinical Research Data: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18267.
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Yale/Medtronic Experience

RICHARD KUNTZ

Senior Vice President

Chief Scientific, Clinical and Regulatory Officer

Medtronic, Inc.

11:40 a.m.

Models That Foster Pooling and Analysis of Data

FNIH Biomarkers Consortium Adiponectin Project

JOHN WAGNER

Vice President, Clinical Pharmacology

Merck & Co., Inc.

Novel Methods Leading to New Medications in Depression and Schizophrenia (NEWMEDS) Consortium

JONATHAN RABINOWITZ

Academic Lead, NEWMEDS Work Package on

Advanced Data Analysis Techniques

Bar Ilan University

12:10 p.m.

Series of Brief Presentations on Overcoming Challenges Facing Clinical Trial Data Sharing

Challenge #1: Permissions

JENNIFER GEETTER

Partner

McDermott Will & Emery

Challenge #2: Techniques and Methodologies

JOHN IOANNIDIS (via video conference)

C.F. Rehnborg Chair in Disease Prevention

Stanford University

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2013. Sharing Clinical Research Data: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18267.
×

Challenge #3: Culture

KELLY EDWARDS

Acting Associate Dean, The Graduate School

Associate Professor, Bioethics and Humanities

University of Washington

12:40 p.m.

Discussion among speakers, panelists, and audience

Discussant:

•   Sally Okun, Health Data Integrity & Patient Safety, PatientsLikeMe

Discussion Moderator

JEFFREY NYE, Session Chair

Vice President

Neuroscience Innovation and Partnership Strategy

Janssen Research & Development, LLC

1:00 p.m.

LUNCH

KEYNOTE CASE STUDY: DISTRIBUTED SYSTEMS FOR CLINICAL RESEARCH INFORMATION SHARING

1:30 p.m.

RICHARD PLATT

Professor and Chair

Department of Population Medicine

Harvard Pilgrim Health Care Institute and Harvard

Medical School

1:50 p.m.

Discussion with Speaker and Audience

Discussion Moderator

SHARON TERRY, Workshop Chair

President and Chief Executive Officer

Genetic Alliance

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2013. Sharing Clinical Research Data: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18267.
×

SESSION III: STANDARDIZATION AND GOVERNANCE

Session Objectives:

•   Receive an update on recent legislative and regulatory language regarding standardization of clinical research data and discuss how stakeholders are designing and implementing data standardization plans in response.

•   Discuss the relative cost–benefit of data conversion of existing trial data versus building an infrastructure to improve data collection and sharing moving forward.

•   Present case studies from data-sharing projects using different data standardization and governance models and consider lessons learned or best practices for the future.

2:00 p.m.

Background and Session Objectives

FRANK ROCKHOLD, Session Co-Chair

Senior Vice President, Global Clinical Safety and Pharmacovigilance

GlaxoSmithKline Pharmaceuticals Research and Development

LYNN HUDSON, Session Co-Chair

Chief Science Officer and Executive Director

Coalition Against Major Diseases

Critical Path Institute

2:10 p.m.

PDUFA Update on Data Standards

RON FITZMARTIN

Senior Advisor, Office of Planning and Analysis

Center for Drug Evaluation and Research

U.S. Food and Drug Administration

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2013. Sharing Clinical Research Data: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18267.
×

2:25 p.m.

Standardization to Facilitate Data Sharing: Opportunities and Limitations

CDISC Efforts to Support Clinical Research Data

REBECCA KUSH

President and Chief Executive Officer

Clinical Data Interchange Standards Consortium

HL7 Efforts to Support Clinical Care Data

CHARLES JAFFE

Chief Executive Officer

Health Level 7 International

Health Information Technology Perspective on Clinical Research Data Standards

SACHIN JAIN

Chief Medical Information and Innovation Officer

Merck & Co., Inc.

3:10 p.m.

Discussion with speakers and audience

3:30 p.m.

BREAK

3:45 p.m.

Cost–Benefit Analysis of Retrospective vs. Prospective Data Standardization

VICKI SEYFERT-MARGOLIS

Senior Advisor, Science Innovation and Policy

Office of the Chief Scientist

U.S. Food and Drug Administration

4:00 p.m.

Case Studies: Standardization and Governance Models in Data Sharing

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2013. Sharing Clinical Research Data: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18267.
×

Critical Path Institute and Coalition Against Major Diseases Alzheimer’s Clinical Trial Database

CAROLYN COMPTON

President and Chief Executive Officer

Critical Path Institute

Translational Medicine Mart (tranSMART)

ERIC PERAKSLIS

Chief Information Officer and Chief Scientist, Informatics

U.S. Food and Drug Administration

4:30 p.m.

Panel Discussion

•   Catalog new data-sharing challenges not yet discussed and provide suggestions for overcoming these challenges.

•   Given the data standardization and governance models discussed, suggest a framework to guide the development of new data-sharing projects based on their purpose (e.g., regulatory approval with FDA, detecting safety signals, testing secondary hypotheses, etc.).

Panelists

LAURA LYMAN RODRIGUEZ

Director

Office of Policy, Communications and Education

National Human Genome Research Institute

MEREDITH NAHM

Associate Director for Clinical Research Informatics

Duke Translational Medicine Institute

NEIL DE CRESCENZO

Senior Vice President and General Manager

Oracle Health Sciences

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2013. Sharing Clinical Research Data: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18267.
×

MICHAEL CANTOR

Senior Director

Clinical Informatics and Innovation

Pfizer Inc.

Panel Moderators

FRANK ROCKHOLD, Session Co-Chair

Senior Vice President, Global Clinical Safety and Pharmacovigilance

GlaxoSmithKline Pharmaceuticals Research and Development

LYNN HUDSON, Session Co-Chair

Chief Science Officer and Executive Director

Coalition Against Major Diseases

Critical Path Institute

5:30 p.m.

Adjourn Day One


October 5, 2012
Day Two

8:00 a.m.

Opening Remarks

SHARON TERRY, Workshop Chair

President and Chief Executive Officer

Genetic Alliance

SESSION IV: INCENTIVIZING POLICY AND CULTURAL SHIFTS TO ENHANCE DATA SHARING

Session Objectives:

•   Receive an update on clinical trial data transparency decisions in Europe.

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2013. Sharing Clinical Research Data: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18267.
×

•   Explore current incentives for and against (i.e., benefits and risks of) data sharing within and across sectors and suggest mechanisms to encourage stakeholders to engage in a culture of data sharing.

•   Identify existing and potential strategies, including technology-based approaches, for protecting patient privacy and confidentiality while facilitating data sharing.

8:10 a.m.

Background and Session Objectives

ROBERT HARRINGTON, Session Chair

Arthur L. Bloomfield Professor of Medicine

Chair, Department of Medicine

Stanford University

8:20 a.m.

Clinical Trial Data Transparency: European Medicines Agency Perspective

HANS-GEORG EICHLER

Senior Medical Officer

European Medicines Agency

8:40 a.m.

Clinical Research Data Sharing Practices and Attitudes

ANDREW VICKERS

Attending Research Methodologist

Department of Epidemiology and Biostatistics

Memorial Sloan-Kettering Cancer Center

8:55 a.m.

Overview of Data-Sharing Policies: Research Funders and Publishers

STEVEN GOODMAN

Associate Dean for Clinical and Translational Research

Professor of Medicine & Health Research and Policy
Stanford University School of Medicine

9:10 a.m.

Series of Presentations: Incentives for Data Sharing Within and Across Sectors

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2013. Sharing Clinical Research Data: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18267.
×

Academic Perspectives

PETER DOSHI

Postdoctoral Fellow

Johns Hopkins University School of Medicine

BETH KOZEL

Instructor of Pediatrics

Division of Genetics and Genomic Medicine

St. Louis Children’s Hospital and Washington

University School of Medicine

Federal Research Funder Perspective

JOSEPHINE BRIGGS

Director, National Center for Complementary and

Alternative Medicine

Director, National Center for Advancing Translation

Sciences, Division of Clinical Innovation

National Institutes of Health

9:55 a.m.

Discussion with speakers and audience

10:30 a.m.

BREAK

10:45 a.m.

Facilitating Patient Ownership of Clinical Trial Data: Technical Challenges and Opportunities

JOHN WILBANKS

Director

Sage Bionetworks

DEVEN MCGRAW

Director, Health Privacy Project

Center for Democracy and Technology

11:15 a.m.

Discussion with speakers and audience

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2013. Sharing Clinical Research Data: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18267.
×

SESSION V: NEXT STEPS AND FUTURE DIRECTIONS

Session Objectives:

•   Discuss key themes from the workshop.

•   Based on workshop presentations and discussions, identify potential next steps and priority actions for data-sharing stakeholders to take action.

•   Highlight potential opportunities and challenges that are currently on the horizon, but may become more salient as technology evolves and/or data sharing becomes more pervasive.

11:30 a.m.

Background and Session Objectives

SHARON TERRY, Workshop Chair

President and Chief Executive Officer

Genetic Alliance

11:40 a.m.

Session Chair Reports (5 minutes per session)

WILLIAM POTTER, Session I Co-Chair

Co-Chair Emeritus

Neuroscience Steering Committee

FNIH Biomarkers Consortium

DEBORAH ZARIN, Session I Co-Chair

Director, ClinicalTrials.gov

National Library of Medicine

National Institutes of Health

JEFFREY NYE, Session II Chair

Vice President

Neuroscience Innovation and Partnership Strategy

Janssen Research & Development, LLC

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2013. Sharing Clinical Research Data: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18267.
×

FRANK ROCKHOLD, Session III Co-Chair

Senior Vice President

Global Clinical Safety and Pharmacovigilance

GlaxoSmithKline Pharmaceuticals Research and Development

LYNN HUDSON, Session III Co-Chair

Chief Science Officer and Executive Director

Coalition Against Major Diseases, Critical Path Institute

ROBERT HARRINGTON, Session IV Chair

Arthur L. Bloomfield Professor of Medicine

Chair, Department of Medicine

Stanford University

12:00 p.m.

Closing Discussion with Session Chairs, Panelists, and Audience Led by Workshop Chair

JOSEPHINE BRIGGS

Director, National Center for Complementary and

Alternative Medicine

Director, National Center for Advancing Translation

Sciences, Division of Clinical Innovation

National Institutes of Health

MICHAEL ROSENBLATT

Executive Vice President and Chief Medical Officer

Merck & Co., Inc.

JAY “MARTY” TENENBAUM

Founder and Chair

Cancer Commons

JANET WOODCOCK

Director, Center for Drug Evaluation and Research

U.S. Food and Drug Administration

12:45 p.m.

ADJOURN

Suggested Citation:"Appendix A: Workshop Agenda." Institute of Medicine. 2013. Sharing Clinical Research Data: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18267.
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Pharmaceutical companies, academic researchers, and government agencies such as the Food and Drug Administration and the National Institutes of Health all possess large quantities of clinical research data. If these data were shared more widely within and across sectors, the resulting research advances derived from data pooling and analysis could improve public health, enhance patient safety, and spur drug development. Data sharing can also increase public trust in clinical trials and conclusions derived from them by lending transparency to the clinical research process. Much of this information, however, is never shared. Retention of clinical research data by investigators and within organizations may represent lost opportunities in biomedical research. Despite the potential benefits that could be accrued from pooling and analysis of shared data, barriers to data sharing faced by researchers in industry include concerns about data mining, erroneous secondary analyses of data, and unwarranted litigation, as well as a desire to protect confidential commercial information. Academic partners face significant cultural barriers to sharing data and participating in longer term collaborative efforts that stem from a desire to protect intellectual autonomy and a career advancement system built on priority of publication and citation requirements. Some barriers, like the need to protect patient privacy, pre- sent challenges for both sectors. Looking ahead, there are also a number of technical challenges to be faced in analyzing potentially large and heterogeneous datasets.

This public workshop focused on strategies to facilitate sharing of clinical research data in order to advance scientific knowledge and public health. While the workshop focused on sharing of data from preplanned interventional studies of human subjects, models and projects involving sharing of other clinical data types were considered to the extent that they provided lessons learned and best practices. The workshop objectives were to examine the benefits of sharing of clinical research data from all sectors and among these sectors, including, for example: benefits to the research and development enterprise and benefits to the analysis of safety and efficacy. Sharing Clinical Research Data: Workshop Summary identifies barriers and challenges to sharing clinical research data, explores strategies to address these barriers and challenges, including identifying priority actions and "low-hanging fruit" opportunities, and discusses strategies for using these potentially large datasets to facilitate scientific and public health advances.

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