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



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Vaccine Safety Research, Data Access, and Public Trust 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

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Vaccine Safety Research, Data Access, and Public Trust 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

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Vaccine Safety Research, Data Access, and Public Trust 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

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Vaccine Safety Research, Data Access, and Public Trust 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