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Observational Studies in a Learning Health System: Workshop Summary (2013)

Chapter: Appendix C: Workshop Participants

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Suggested Citation:"Appendix C: Workshop Participants." Institute of Medicine. 2013. Observational Studies in a Learning Health System: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18438.
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Appendix C

Workshop Participants

Jill Abell, PhD, MPH

Senior Director, Clinical Effectiveness and Safety

GlaxoSmithKline

Naomi Aronson

Executive Director

Blue Cross Blue Shield

Peter Bach, MD, MAPP

Attending Physician

Department of Epidemiology & Biostatistics

Memorial Sloan-Kettering Cancer Center

Anirban Basu, MS, PhD

Associate Professor and Director

Program in Health Economics and Outcomes Methodology

University of Washington

Lawrence Becker

Director, Benefits

Xerox Corporation

Marc L. Berger, MD

Vice President, Real World Data and Analytics

Pfizer Inc.

Robert M. Califf, MD

Vice Chancellor for Clinical Research

Duke University Medical Center

Mary E. Charlson, MD

Chief, Clinical Epidemiology and Evaluative Sciences Research

Weill Cornell Medical College

Jennifer B. Christian, PharmD, MPH, PhD

Senior Director, Clinical Effectiveness and Safety

GlaxoSmithKline

Mark R. Cullen, MD

Professor of Medicine

Stanford University School of Medicine

Suggested Citation:"Appendix C: Workshop Participants." Institute of Medicine. 2013. Observational Studies in a Learning Health System: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18438.
×

Steven R. Cummings, MD, FACP

Professor Emeritus, Department of Medicine

University of California, San Francisco

Robert W. Dubois, MD, PhD

Chief Science Officer

National Pharmaceutical Council

Rachael L. Fleurence, PhD

Acting Director, Accelerating PCORI Methods Program

PCORI

Dean Follmann, PhD

Branch Chief-Associate Director for Biostatistics

National Institutes of Health

Constantine Frangakis, PhD

Professor, Department of Biostatistics

Johns Hopkins Bloomberg School of Public Health

Mitchell H. Gail, MD, PhD

Senior Investigator

National Cancer Institute

Kathleen R. Gans-Brangs, PhD

Senior Director, Medical Affairs

AstraZeneca

Steven N. Goodman, MD, PhD

Associate Dean for Clinical and Translational Research

Stanford University School of Medicine

Sheldon Greenfield, MD

Executive Co-Director, Health Policy Research Institute

University of California, Irvine

Joel B. Greenhouse, PhD

Professor of Statistics

Carnegie Mellon University

Sean Hennessy, PharmD, PhD

Associate Professor of Epidemiology

University of Pennsylvania

Miguel Hernán, MD, DrPH, ScM, MPH

Professor of Epidemiology

Harvard University

Mark A. Hlatky, MD

Professor, Stanford Health Policy Fellow

Department of Health Research and Policy

Stanford University

Ralph I. Horwitz, M.D.

Senior Vice President, Clinical Science Evaluation

GlaxoSmithKline

Gail Hunt

President and Chief Executive Officer

National Alliance for Caregiving

Robert Jesse, MD, PhD

Principal Deputy Under Secretary for Health

Department of Veterans Affairs

Suggested Citation:"Appendix C: Workshop Participants." Institute of Medicine. 2013. Observational Studies in a Learning Health System: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18438.
×

Eloise E. Kaizar, PhD

Associate Professor

Department of Statistics

The Ohio State University

Jerome P. Kassirer, MD

Distinguished Professor

Tufts University School of Medicine

Michael Kattan, PhD

Quantitative Health Sciences Department Chair

Cleveland Clinic

David M. Kent, MD, MSc

Director, Clinical and Translational Science Program

Tufts University Sackler School of Graduate Biomedical Sciences

Michael S. Lauer, MD, FACC, FAHA

Director, Division of Cardiovascular Sciences

National Heart, Lung, and Blood Institute

J. Michael McGinnis, MD, MPP, MA

Senior Scholar

Institute of Medicine

David O. Meltzer, PhD

Associate Professor

University of Chicago

Nancy E. Miller, PhD

Senior Science Policy Analyst

Office of Science Policy

National Institutes of Health

Sally Morton, PhD

Professor and Chair, Department of Biostatistics

Graduate School of Public Health

University of Pittsburgh

Cynthia D. Mulrow, MD, MSc

Senior Deputy Editor

Annals of Internal Medicine

Robin Newhouse

Chair and Associate Professor

University of Maryland School of Nursing

Perry D. Nisen, MD, PhD

SVP, Science and Innovation

GlaxoSmithKline

Richard Platt, MD, MS

Chair, Ambulatory Care and Prevention

Chair, Population Medicine

Harvard University

James Robins, MD

Mitchell L. and Robin LaFoley Dong Professor of Epidemiology

Harvard University

Patrick Ryan, PhD

Head of Epidemiology Analytics

Janssen Research and Development

Nancy Santanello, MD, MS

Vice President, Epidemiology

Merck & Co.

Richard L. Schilsky, MD, FASCO

Chief Medical Officer

American Society of Clinical Oncology

Sebastian Schneeweiss, MD

Associate Professor, Epidemiology

Division of Pharmacoepidemiology and Pharmacoeconomics

Brigham and Women’s Hospital

J. Sanford Schwartz, MD

Leon Hess Professor in Internal Medicine

University of Pennsylvania School of Medicine

Jodi Segal, MD, MPH

Director, Pharmacoepidemiology Program

The John Hopkins Medical Institutions

Joe V. Selby, MD, MPH

Executive Director

PCORI

Burton H. Singer, PhD, MS

Professor, Emerging Pathogens Institute

University of Florida

Jean Slutsky, PA, MS

Director, Center for Outcomes and Evidence

Agency for Healthcare Research and Quality

Dylan Small, PhD

Associate Professor of Statistics

University of Pennsylvania

Harold C. Sox, MD

Professor of Medicine

Dartmouth Geisel School of Medicine

Elizabeth A. Stuart

Associate Professor, Department of Biostatistics

Johns Hopkins Bloomberg School of Public Health

Nicholas Tatonetti, PhD

Assistant Professor of Biomedical Informatics

Columbia University

Robert Temple, MD

Deputy Center Director for Clinical Science

U.S. Food and Drug Administration

William S. Weintraub, MD, FACC

John H. Ammon Chair of Cardiology

Christiana Care Health Services

Harlan Weisman

Managing Director

And-One Consulting, LLC

John B. Wong, MD

Professor of Medicine

Tufts University Sackler School of Graduate Biomedical Sciences

Michael S. Lauer, MD, FACC, FAHA

Director, Division of Cardiovascular Sciences

National Heart, Lung, and Blood Institute

J. Michael McGinnis, MD, MPP, MA

Senior Scholar

Institute of Medicine

David O. Meltzer, PhD

Associate Professor

University of Chicago

Nancy E. Miller, PhD

Senior Science Policy Analyst

Office of Science Policy

National Institutes of Health

Sally Morton, PhD

Professor and Chair, Department of Biostatistics

Graduate School of Public Health

University of Pittsburgh

Cynthia D. Mulrow, MD, MSc

Senior Deputy Editor

Annals of Internal Medicine

Robin Newhouse

Chair and Associate Professor

University of Maryland School of Nursing

Perry D. Nisen, MD, PhD

SVP, Science and Innovation

GlaxoSmithKline

Richard Platt, MD, MS

Chair, Ambulatory Care and Prevention

Chair, Population Medicine

Harvard University

James Robins, MD

Mitchell L. and Robin LaFoley Dong Professor of Epidemiology

Harvard University

Patrick Ryan, PhD

Head of Epidemiology Analytics

Janssen Research and Development

Nancy Santanello, MD, MS

Vice President, Epidemiology

Merck & Co.

Richard L. Schilsky, MD, FASCO

Chief Medical Officer

American Society of Clinical Oncology

Suggested Citation:"Appendix C: Workshop Participants." Institute of Medicine. 2013. Observational Studies in a Learning Health System: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18438.
×

Sebastian Schneeweiss, MD

Associate Professor, Epidemiology

Division of Pharmacoepidemiology and Pharmacoeconomics

Brigham and Women’s Hospital

J. Sanford Schwartz, MD

Leon Hess Professor in Internal Medicine

University of Pennsylvania School of Medicine

Jodi Segal, MD, MPH

Director, Pharmacoepidemiology Program

The John Hopkins Medical Institutions

Joe V. Selby, MD, MPH

Executive Director

PCORI

Burton H. Singer, PhD, MS

Professor, Emerging Pathogens Institute

University of Florida

Jean Slutsky, PA, MS

Director, Center for Outcomes and Evidence

Agency for Healthcare Research and Quality

Dylan Small, PhD

Associate Professor of Statistics

University of Pennsylvania

Harold C. Sox, MD

Professor of Medicine

Dartmouth Geisel School of Medicine

Elizabeth A. Stuart

Associate Professor, Department of Biostatistics

Johns Hopkins Bloomberg School of Public Health

Nicholas Tatonetti, PhD

Assistant Professor of Biomedical Informatics

Columbia University

Robert Temple, MD

Deputy Center Director for Clinical Science

U.S. Food and Drug Administration

William S. Weintraub, MD, FACC

John H. Ammon Chair of Cardiology

Christiana Care Health Services

Harlan Weisman

Managing Director

And-One Consulting, LLC

John B. Wong, MD

Professor of Medicine

Tufts University Sackler School of Graduate Biomedical Sciences

Suggested Citation:"Appendix C: Workshop Participants." Institute of Medicine. 2013. Observational Studies in a Learning Health System: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18438.
×
Page 111
Suggested Citation:"Appendix C: Workshop Participants." Institute of Medicine. 2013. Observational Studies in a Learning Health System: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18438.
×
Page 112
Suggested Citation:"Appendix C: Workshop Participants." Institute of Medicine. 2013. Observational Studies in a Learning Health System: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18438.
×
Page 113
Suggested Citation:"Appendix C: Workshop Participants." Institute of Medicine. 2013. Observational Studies in a Learning Health System: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18438.
×
Page 114
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Clinical research strains to keep up with the rapid and iterative evolution of medical interventions, clinical practice innovation, and the increasing demand for information on the clinical effectiveness of these advancements. In response to the growing availability of archived and real-time digital health data and the opportunities this data provides for research, as well as the increasing number of studies using prospectively collected clinical data, the Institute of Medicine's Roundtable on Value & Science-Driven Health Care convened a workshop on Observational Studies in a Learning Health System. Participants, including experts from a wide range of disciplines - clinical researchers, statisticians, biostatisticians, epidemiologists, health care informaticians, health care analytics, research funders, health products industry, clinicians, payers, and regulators - explored leading edge approaches to observational studies, charted a course for the use of the growing health data utility, and identified opportunities to advance progress. Workshop speakers and individual participants strove to identify stakeholder needs and barriers to the broader application of observational studies.

Observational Studies in a Learning Health Systemis the summary of the workshop. This report explores the role of observational studies in the generation of evidence to guide clinical and health policy decisions. The report discusses concepts of rigorous observational study design and analysis, emerging statistical methods, and opportunities and challenges of observational studies to complement evidence from experimental methods, treatment heterogeneity, and effectiveness estimates tailored toward individual patients.

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