Tuesday, January 11, 2005
|
| 8:00 a.m. |
Welcome and Introduction -
PDF file, 32 K |
Text-only version
Barnett S. Kramer,
M.D., M.P.H.
Associate Director for Disease Prevention
Office of the
Director
National Institutes of Health |
| 8:15 a.m. |
Introductory Remarks
Elias A. Zerhouni, M.D.
Director
National Institutes of Health
|
| I. |
Background
Chair: Barnett S. Kramer, M.D., M.P.H. |
| 8:30 a.m. |
History of Evidence-Based Medicine and Evidence-Based
Health Policy - PDF file, 46 K |
Text-only version
Marcia L. Meldrum,
Ph.D.
Lecturer/Researcher
History and Special Collections
Biomedical Library
University of California, Los Angeles |
| 8:50 a.m. |
Lessons Learned: Clinical Studies -
PDF file, 261 K |
Text-only version
Maria Elena
Martinez, Ph.D.
Associate Professor of Epidemiology and Nutrition
Arizona Cancer Center |
| 9:10 a.m. |
Lessons Learned: Surrogate and Intermediate
Endpoints - PDF file, 202 K |
Text-only version
David DeMets, Ph.D.
Professor and Chair
Department of Biostatistics and Medical
Informatics University of Wisconsin |
| II. |
Distinguishing Causal
From Noncausal Associations
Chair: Griffin P. Rodgers, M.D., F.A.C.P.
Chief Molecular and Clinical Hematology Branch
Deputy Director
National Institute of Diabetes and Digestive and Kidney Diseases
National Institutes of Health |
| 9:30 a.m. |
The Systematic Literature Review Process and Analytic
Framework (Causal Pathway) - PDF file,
68 K | Text-only version
David Atkins,
M.D., M.P.H.
Chief Medical Officer
Center for Outcomes and Evidence
Agency for Healthcare Research and Quality |
| 9:50 a.m. |
Traditional Approaches: Koch's Postulates and Austin
Bradford-Hill Criteria for Causality - PDF
file, 32 K | Text-only version
Julie
Buring, Sc.D.
Professor of Medicine
Brigham and Women's Hospital
Harvard Medical School |
| 10:10 a.m. |
The Contribution of
Biomarkers to Determining Causality
Arthur Schatzkin, M.D., Dr.P.H.
Chief Nutritional Epidemiology Branch
Division of Cancer Epidemiology
and Genetics
National Cancer Institute
National Institutes of Health
|
| 10:30 a.m. |
Break |
| 10:45 a.m. |
Issues Intrinsic to Behavioral and Other Complex
Interventions - PDF file, 105 K |
Text-only version
William Shadish,
Ph.D.
Professor
School of Social Sciences, Humanities, and Arts
University of California, Merced |
| 11:05 a.m. |
Rapporteur
Paul A. Godley, M.D., Ph.D., M.P.P.
Clinical Associate Professor,
Epidemiology
Adjunct Associate Professor, Biostatistics School of Public
Health
Associate Professor of Medicine
Division of Hematology/Oncology
School of Medicine
University of North Carolina at Chapel Hill |
| 11:20 a.m. |
Discussion |
| 12:20 p.m. |
Lunch |
| III. |
Evaluating and
Grading Strength of Evidence
Chair: Lawrence M. Friedman, M.D.
Acting Deputy Director
National Heart, Lung, and Blood Institute
National Institutes of Health |
| 1:20 p.m. |
Strengths and Limitations of Common Study
Designs - PDF file, 42 K |
Text-only version
Sylvan B. Green, M.D.
Professor of Public Health
Director of Biometry
Linda McCartney
Breast Cancer Chair in Biometry
Arizona Cancer Center
University of
Arizona Health Sciences Center |
| 1:40 p.m. |
Formal Evidence Grading Methods -
PDF file, 147 K |
Text-only version
Russell P. Harris,
M.D., M.P.H.
Associate Professor of Medicine
Cecil G. Sheps Center for
Health Services
Research University of North Carolina at Chapel Hill |
| 2:00 p.m. |
Concepts in Practice: Medical Screening -
PDF file, 1,395 K |
Text-only version
Otis W. Brawley,
M.D.
Professor of Hematology and Oncology
Associate Director for Cancer
Control
Emory University School of Medicine |
| 2:20 p.m. |
Clash Between Data, Practice, and Policy -
PDF file, 1,431 K |
Text-only version
Paul Shekelle, M.D.
Director Southern California Evidence-Based Practice Center
RAND
Corporation |
| 2:35 p.m. |
Rapporteur
Elizabeth Barrett-Connor, M.D.
Professor and Chief
Division of
Epidemiology
Department of Family and Preventive Medicine
University of
California, San Diego |
| 2:50 p.m. |
Break |
| 3:05 p.m. |
Discussion |
| IV. |
Evaluating Study
Outcomes: Biomarkers, Intermediate Endpoints, and Surrogate Endpoints
Chair: Richard J. Hodes, M.D.
Director
National Institute on Aging
National Institutes of Health |
| 4:05 p.m. |
Surrogate Endpoint Definition and Application
- PDF file, 63 K |
Text-only version
Ross L. Prentice,
Ph.D.
Member Fred Hutchinson Cancer Research Center |
| 4:25 p.m. |
Recent Approaches to Surrogate Endpoint Validation
(References) - PDF
file, 66 K | Text-only version
Stuart
G. Baker, Sc.D.
Mathematical Statistician Biometry Research Group
National Cancer Institute
National Institutes of Health |
| 4:45 p.m. |
New Complexity: The "Omics" Revolution -
PDF file, 2,080 K |
Text-only version
David F. Ransohoff,
M.D.
Professor of Medicine
School of Medicine
University of North
Carolina at Chapel Hill |
| 5:05 p.m. |
Adjourn |
|
Back to Top |
Wednesday, January 12,
2005 |
| 8:00 a.m. |
Introduction and
Remarks |
| 8:05 a.m. |
Methods of Biomarker Validation -
PDF file, 170 K | Text-only version
Daniel F. Hayes, M.D.
Professor
Department of Internal Medicine
University of Michigan
Comprehensive Cancer Center |
| 8:25 a.m. |
Rapporteur - PDF
file, 309 K | Text-only version
Joseph
Lau, M.D.
Director
Tufts-New England Medical Center Evidence-Based
Practice Center
Tufts University School of Medicine |
| 8:40 a.m. |
Discussion |
| V. |
Expressing Study
Results to the Professional and Public Communities
Chair: Duane
Alexander, M.D.
Director National Institute of Child Health and Human
Development
National Institutes of Health |
| 9:40 a.m. |
Methods of Expressing
Results I
Steven Woloshin, M.D., M.S.
Senior Research Associate,
VA Outcomes Group,
White River Junction, VT
Associate Professor of
Medicine and Community and Family Medicine
Dartmouth Medical School,
Hanover, NH
Veterans Affairs Medical Center |
| 10:00 a.m. |
Methods of Expressing
Results II
Lisa Schwartz, M.D., M.S.
Senior Research Associate,
VA Outcomes Group
White River Junction, VT
Associate Professor of
Medicine and Community and Family Medicine
Dartmouth Medical School,
Hanover, NH
Veterans Affairs Medical Center |
| 10:20 a.m. |
Break |
| 10:35 a.m. |
How Likely Is a Positive Finding To Be
Wrong? - PDF file, 153 K |
Text-only version
Sholom Wacholder,
Ph.D.
Senior Investigator
Division of Cancer Epidemiology and Genetics
National Cancer Institute
National Institutes of Health |
| 10:55 a.m. |
Role of Advocates in
Conveying and Using Scientific Findings
Mark Harrington
Executive
Director
Treatment Action Group |
| 11:15 a.m. |
Perspective of the
Medical Journalist
Robert Bazell
Chief Health and Science
Correspondent
NBC News |
| 11:35 a.m. |
Rapporteur
Duane Alexander, M.D. |
| 11:50 a.m. |
Discussion |
| 12:50 p.m. |
Lunch |
| VI. |
The Data and Safety
Monitoring Board: Should This Trial Be Stopped?
Chair: Amy Patterson,
M.D.
Director Clinical Research Policy Analysis and Coordination
Director
Office of Biotechnology Activities
Office of Science
Policy
Office of the Director
National Institutes of Health |
| 1:50 p.m. |
The Interface of Science, Ethics, and Policy
- PDF file, 1,797 K |
Text-only version
Lawrence M.
Friedman, M.D. |
| 2:10 p.m. |
Discussion |
| VII. |
Putting It All
Together: Translating Data Into Health Policy
Chair: Ruth L.
Kirschstein, M.D.
Senior Advisor to the Director
National Institutes of
Health |
| 2:40 p.m. |
How Much Benefit Is Good Enough? -
PDF file, 112 K |
Text-only version
Muriel Gillick, M.D.
Associate Professor
Department of Ambulatory Care and Prevention
Harvard Medical School |
| 3:00 p.m. |
Opportunity Costs and
Societal Tradeoffs
Jonathan E. Fielding, M.D., M.P.H., M.B.A.
Director of Public Health and Health Officer
County of Los Angeles
Professor of Health Services and Pediatrics
School of Public Health and
Medicine
University of California, Los Angeles |
| 3:20 p.m. |
Third-Party Payer Perspective -
PDF file, 28 K |
Text-only version
Bernard J. Mansheim,
M.D.
Senior Vice President
Chief Medical Officer
Coventry Health
Care, Incorporated |
| 3:40 p.m. |
Rapporteur - PDF
file, 41 K | Text-only version
Harold
Sox, M.D.
Editor Annals of Internal Medicine |
| 3:55 p.m. |
Discussion |
| 4:55 p.m. |
Adjourn |
| |
|
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