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Developing a National Registry of Pharmacologic and Biologic Clinical Trials Workshop Report (2006) / Chapter Skim
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Appendix B Workshop Agenda, Speakers, Panelists, and Participants - June 27, 2005
Pages 51-62

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From page 51...
... B Workshop Agenda, Speakers, Panelists, and Participants: June 27, 2005 Workshop Agenda 8:30 WELCOME AND OPENING REMARKS Philip A Pizzo Chair, IOM Board on Health Sciences Policy Dean, Stanford University School of Medicine Gail Cassell Member, IOM Council and Board on Health Sciences Policy Vice President, Scientific Affairs and Distinguished Lilly Research Scholar for Infectious Diseases Eli Lilly and Company OVERVIEW & BACKGROUND 8:45 KEYNOTE: IMPORTANCE OF THE PUBLIC TRUST The Honorable John Porter Partner Hogan & Hartson, LLP 9:15 STATUS OF IOM BOARD ACTIVITY Philip A
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From page 52...
... 52 DEVELOPING A NATIONAL REGISTRY PANEL 1: PATIENT/PUBLIC/JOURNAL EDITORS PERSPECTIVE 9:45 PATIENT/PUBLIC NEEDS Marjorie Speers Executive Director Association for the Accreditation of Human Research Protection Programs DISCUSSANTS: Miriam O'Day Senior Director of Public Policy Alpha-1 Foundation Sharon Terry President and CEO Genetic Alliance Jeanne Ireland Director of Public Policy Elizabeth Glaser Pediatric AIDS Foundation 10:00 DISCUSSION 10:15 CLINICAL TRIAL REGISTRY REQUIREMENTS: INTERNATIONAL COMMITTEE OF MEDICAL JOURNAL EDITORS Harold Sox Editor Annals of Internal Medicine DISCUSSANTS: Catherine DeAngelis Editor-in-Chief JAMA Jeffrey Drazen Editor-in-Chief NEJM 10:30 DISCUSSION
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From page 53...
... U.S. Food and Drug Administration 11:45 DISCUSSION 12:00 LUNCH 1:00 PERSPECTIVES FROM NIH AND SURVEY OF DATA IN CLINICALTRIALS.GOV Deborah Zarin Director, ClinicalTrials.gov Lister Hill National Center for Biomedical Communications National Library of Medicine 1:15 DISCUSSION
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From page 54...
... 54 DEVELOPING A NATIONAL REGISTRY 1:30 WORLD HEALTH ORGANIZATION CLINICAL TRIAL REGISTRY PROJECT Metin Gulmezoglu Scientist World Health Organization 1:45 DISCUSSION PANEL 3: ACADEMIC PERSPECTIVES 2:00 PRESENTER: P Pearl O'Rourke Director, Human Research Affairs Partners HealthCare System, Inc.
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From page 56...
... Pearl O'Rourke Robert Temple Director, Human Research Affairs Director, Office of Medical Partners HealthCare System, Inc. Policy Center for Drug Evaluation and The Honorable John Porter Research (CDER)
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From page 57...
... APPENDIX B 57 Registered Workshop Participants Margaret Anderson Laquitta Bowers FasterCures Self-Employed Debra Aronson Steven Brotman BIO Wyeth Pharmaceuticals Naomi Aronson Voncelia Brown Blue Cross Blue Shield Association Salisbury University Angela Bates Mario Browne NIH University of Pittsburgh Graduate School of Public Peggy Beat Health Cleveland VA Suanna Bruinooge Annetta Beauregard American Society of Clinical Eli Lilly and Company Oncology Lisa Begg Kristin Butterfield DHHS/NIH American Academy of Pediatrics Mario Belledonne Ronald Califre Biolab Research Novartis Pharmaceuticals Corporation Douglas Boenning Children's National Medical Center Scott Campbell American Diabetes Association Michele Boisse American Society for Clinical Dolph Chianchiano Pharmacology & Therapeutics National Kidney Foundation, Inc. Claire Bornstein Yen-pin Chiang Elizabeth Glaser Pediatric AIDS AHRQ Foundation Anita Cicero Lizbet Boroughs Gardner, Carton & Douglas American Psychiatric Association Michelle Cissell Lynn Bosco JDRF AHRQ Mickey Clarke Washington University
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From page 58...
... 58 DEVELOPING A NATIONAL REGISTRY Elaine Collier Lorraine Fitzsimmons National Center for Research National Institute on Aging Resources Yolanda Fleming Sarah Comley National Medical Association International Observers MaryAnn Foote Christina Copty Amgen Aspen Systems Corporation Robert Fulcher Jennifer Couzin American Society of Science Magazine Nephrology Tyler C Cymet, DO Barbara Galen C/O Sinai Hospital of Baltimore Cancer Imaging Program/NCI/NIH MaryAnn D'Alessandro NPPTL Roger Garceau Sanofi-Aventis Kevin Davis National Cancer Institute Edward Garcia Washington Health Advocates Patty Delaney Cancer Liaison Program, FDA Kathryn Goettge NLM Clinical Information Don Detmer Services American Medical Informatics Association Alan Goldhammer PhRMA Jeffrey Dickey Spriggs & Hollingsworth Jennifer Gorman Office of the Director, NIH Barry Dickinson American Medical Association Lakshmi Grama National Cancer Institute Wei Du Adolor Corporation David Grandison Meharry Medical College Brenda Evelyn Food and Drug Administration Donald Greene Veritas Medicine Brian Feit DHHS/HRSA/HAB/DCBP Jeffrey Grossi Johns Hopkins Medicine
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From page 59...
... Nick Ide National Library of Medicine Theresa Lawrence Department of Health and Heather Jameson Human Services Research! America Sue Levi-Pearl Lindsey Johnson Tourette Syndrome Association, U.S.
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From page 60...
... 60 DEVELOPING A NATIONAL REGISTRY Michael Manganiello Susan Norris National Institutes of Health AHRQ Richard Manrow Laura Nufire National Cancer Institute Self-Employed Sherry Marts Joanne Odenkirchen Society for Women's Health NIH/NINDS Research Sharon Olmstead Debra McCoy Schering Plough Arthritis Foundation Paul Parry Christopher McGowen Abigail Alliance for Access to Novo Nordisk, Inc. Clinical Trials Paul Meade Carol Payne Clear Point Health Department of Housing and Urban Development David Miller GlaxoSmithKline JoNell Potter University of Miami Nancy Miller NIH Karla Price Epilepsy Foundation Abdulaziz Mohamed Manchester Health Department Kate Reinhalter U.S.
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From page 61...
... House of Representatives Judith Vaitukaitis Juliette Shih NIH Genzyme William Vaughan David Silk Consumers Union Avalere Health Paula Squire Waterman Paul Sirovatka Office of Research Oversight, American Psychiatric Association Veterans Affairs Douglas Sporn Jill Wechsler Abbott Laboratories Applied Clinical Trials Magazine Linda Temple Beat Widler Regulatory Affairs Professionals Roche Products Limited Society Erin Williams Sona Thakkar Congressional Research Service Office of Education and Special Initiatives Reginald Williams Avalere Health Roni Thaler The Center for Information & Study Marcel Willner on Clinical Research Participation Bristol-Myers Squibb
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From page 62...
... 62 DEVELOPING A NATIONAL REGISTRY Marsha Wilson Gynecologic Cancer Foundation Kim Witherspoon National Cancer Institute Jerome Yates American Cancer Society
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Key Terms

  • clinical trial
  • drug evaluation
  • national library
  • drug administration
  • human services


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