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Vaccine Safety Research, Data Access, and Public Trust (2005)

Chapter: Appendix E Meeting Two—Agenda

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Suggested Citation:"Appendix E Meeting Two—Agenda." Institute of Medicine. 2005. Vaccine Safety Research, Data Access, and Public Trust. Washington, DC: The National Academies Press. doi: 10.17226/11234.
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Appendix E
Meeting Two—Agenda

The National Academies

Institute of Medicine

Committee on Review of NIP’s Research Procedures and Data Sharing Program

Meeting Two

AGENDA

Speakers and Times Subject to Change

Thursday, October 21, 2004

9:00 a.m. – 5:30 p.m.

Meeting Location:

Keck Center of the National Academies

Room 100

500 Fifth Street, NW

Washington, DC 20001

8:30–9:00 a.m.

Registration and Coffee

Suggested Citation:"Appendix E Meeting Two—Agenda." Institute of Medicine. 2005. Vaccine Safety Research, Data Access, and Public Trust. Washington, DC: The National Academies Press. doi: 10.17226/11234.
×

9:00–9:15 a.m.

Welcome, Introductions, and Opening Statement

 

John Bailar, MD, PhD

Committee Chair

9:15–9:35 a.m.

Charge to the Committee—Second Component of Charge

 

Roger Bernier, PhD, MPH

Senior Advisor for Scientific Strategy and Innovation

National Immunization Program

Centers for Disease Control and Prevention

9:35–9:50 a.m.

Questions from the Committee

9:50–10:10 a.m.

A Peer-Reviewed Journal’s Perspective on the Release of Preliminary Findings

 

Harold Sox, MD

Editor

Annals of Internal Medicine

American College of Physicians of Internal Medicine

10:10–10:25 a.m.

Questions from the Committee

10:25–10:40 a.m.

Break

10:40–11:00 a.m.

When to Release Preliminary Findings: Ethical Considerations

 

Charles Weijer, MD, PhD, FRCPC

CIHR Investigator

Associate Professor of Bioethics, Medicine, and Surgery

Adjunct Professor of Philosophy

Department of Bioethics

Dalhousie Medical School

11:00–11:15 a.m.

Questions from the Committee

Suggested Citation:"Appendix E Meeting Two—Agenda." Institute of Medicine. 2005. Vaccine Safety Research, Data Access, and Public Trust. Washington, DC: The National Academies Press. doi: 10.17226/11234.
×

11:15–11:35 a.m.

Communicating Health Risks Identified Through Preliminary Analyses

 

Katherine McComas, PhD

Assistant Professor

Department of Communication

Cornell University

11:35–11:50 a.m.

Questions from the Committee

11:50–12:10 p.m.

When to Release Preliminary Findings: Post-Market Surveillance of Medical Devices

 

Susan Gardner, PhD

Director, Office of Surveillance Biometrics

Center for Devices and Radiological Health Food and Drug Administration

12:10–12:25 p.m.

Questions from the Committee

12:25–1:30 p.m.

Lunch (Cafeteria on 3rd Floor; List of nearby restaurants in folder)

1:30–2:00 p.m.

VSD Studies that Utilized Iterative Analyses

 

Frank DeStefano, MD, MPH

Medical Epidemiologist

National Immunization Program

Centers for Disease Control and Prevention

2:00–2:15 p.m.

Questions from the Committee

2:15–2:35 p.m.

Statistical Methods and Issues Relevant to Iterative Analyses

 

David DeMets, PhD

Professor and Chair

Department of Biostatistics and Medical Informatics

University of Wisconsin-Madison

2:35–2:50 p.m.

Questions from the Committee

Suggested Citation:"Appendix E Meeting Two—Agenda." Institute of Medicine. 2005. Vaccine Safety Research, Data Access, and Public Trust. Washington, DC: The National Academies Press. doi: 10.17226/11234.
×

2:50–3:10 p.m.

Use of Preliminary Findings for Policy Decisions: The Rotavirus Vaccine Experience

 

Melinda Wharton, MD, MPH

Acting Deputy Director

National Immunization Program

Centers for Disease Control and Prevention

3:10–3:25 p.m.

Questions from the Committee

3:25–3:40 p.m.

Break

3:40–4:00 p.m.

Advocacy Group Perspective on Criteria for Releasing Preliminary Findings

 

Sallie Bernard

Executive Director and Co-Founder

SafeMinds

4:00–4:15 p.m.

Questions from the Committee

4:15–4:35 p.m.

Pediatricians’ Perspective on Preliminary Findings as Evidence for Decision-Making

 

Julia McMillan, MD

Professor of Pediatrics

Vice Chair for Pediatric Education

Johns Hopkins University School of Medicine

4:35–4:50 p.m.

Questions from the Committee

4:50–5:20 p.m.

Public Comment

(A sign-up sheet will be available at the registration table)

5:20–5:30 p.m.

Closing Remarks

 

John Bailar, MD, PhD

Committee Chair

Suggested Citation:"Appendix E Meeting Two—Agenda." Institute of Medicine. 2005. Vaccine Safety Research, Data Access, and Public Trust. Washington, DC: The National Academies Press. doi: 10.17226/11234.
×
Page 123
Suggested Citation:"Appendix E Meeting Two—Agenda." Institute of Medicine. 2005. Vaccine Safety Research, Data Access, and Public Trust. Washington, DC: The National Academies Press. doi: 10.17226/11234.
×
Page 124
Suggested Citation:"Appendix E Meeting Two—Agenda." Institute of Medicine. 2005. Vaccine Safety Research, Data Access, and Public Trust. Washington, DC: The National Academies Press. doi: 10.17226/11234.
×
Page 125
Suggested Citation:"Appendix E Meeting Two—Agenda." Institute of Medicine. 2005. Vaccine Safety Research, Data Access, and Public Trust. Washington, DC: The National Academies Press. doi: 10.17226/11234.
×
Page 126
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The Vaccine Safety Datalink (VSD) is a large, linked database of patient information that was developed jointly by CDC and several private managed care organizations in 1991. It includes data on vaccination histories, health outcomes, and characteristics of more than 7 million patients of eight participating health organizations. Researchers from CDC and the managed care groups have used VSD information to study whether health problems are associated with vaccinations. The subsequent VSD data sharing program was launched in 2002 to allow independent, external researchers access to information in the database.

In this report, the committee that was asked to review aspects of this program recommends that two new oversight groups are needed to ensure that the policies and procedures of the VSD and its data sharing program are implemented as fairly and openly as possible.

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