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PAPERBACK list:$31.75 Web:$28.57 add to cart Rights & Permissions Free PDF Access Free Resources Sign in to download PDF book and chapters PDF EXECUTIVE SUMMARY Display this book on your site! Related Titles The Future of Drug Safety: Promoting and Protecting the Health of the Public Preventing Medication Errors: Quality Chasm Series Other Related Titles Developing a National Registry of Pharmacologic and Biologic Clinical Trials: Workshop Report (2006) Board on Health Sciences Policy (HSP) Web Search Builder Use this book's key terms to search within this book, across our collection, or across the Web. Skim This Chapter Skim this chapter and use this chapter's key terms to search within this book. Reference Finder Paste in your own text to find books that relate to your topic. Page 49   E-mail  Facebook  Digg  Stumble  Twitter More The following HTML text is provided to enhance online readability. Many aspects of typography translate only awkwardly to HTML. Please use the page image as the authoritative form to ensure accuracy. A Participants and Invited Experts Between December 1, 2004, and June 27, 2005 Participants December 1, 2004 Alan Breier Vice President, Medical, and Chief Medical Officer Eli Lilly and Company Catherine D.DeAngelis Editor-in-Chief Journal of the American Medical Association Jeffrey M.Drazen Editor-in-Chief New England Journal of Medicine Lawrence Hirsch Executive Director, Medical Communications Merck Research Laboratories Richard Kingham Partner Covington & Burling Ronald Krall Senior Vice President, World Wide Development, GlaxoSmithKline Pharmaceuticals Alexa McCray Director, Lister Hill National Center for Biomedical Communications National Library of Medicine Lana Skirboll (via phone) Associate Director of Science Policy Office of the Director National Institutes of Health Harold C.Sox Editor Annals of Internal Medicine Melvyn L.Sterling Chair, Council on Scientific Affairs American Medical Association Robert Temple (via phone) Director, Office of Medical Policy Center for Drug Evaluation and Research U.S. Food and Drug Administration Elias Zerhouni (via phone) Director National Institutes of Health Page 49 Front Matter (R1-R20) 1 Summary (1-4) 2 The Need for Clinical Trial Registries (5-8) 3 Current Registry Activities (9-18) 4 Content of a Clinical Trial Registry (19-34) 5 Implementation Issues (35-42) 6 Conclusion and Next Steps (43-46) References (47-48) Appendix A Participants and Invited Experts - Between December 1, 2004 and June 27, 2005 (49-50) Appendix B Workshop Agenda, Speakers, Panelists, and Participants - June 27, 2005 (51-62) Appendix C Sec. 113 of the Food and Drug Administration Modernization Act of 1997; Guidance for Industry: Information Programs on Clinical Trials... (63-80) Appendix D Published Journal Editorials (81-90) Appendix E Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases (91-94) Appendix F Illustrative Data Fields for the Results Summary (95-96) Appendix G Biographical Sketches of Committee Members (97-104)

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OCR for page 49
Developing a National Registry of Pharmacologic and Biologic Clinical Trials: Workshop Summary A Participants and Invited Experts Between December 1, 2004, and June 27, 2005 Participants December 1, 2004 Alan Breier Vice President, Medical, and Chief Medical Officer Eli Lilly and Company Catherine D.DeAngelis Editor-in-Chief Journal of the American Medical Association Jeffrey M.Drazen Editor-in-Chief New England Journal of Medicine Lawrence Hirsch Executive Director, Medical Communications Merck Research Laboratories Richard Kingham Partner Covington & Burling Ronald Krall Senior Vice President, World Wide Development, GlaxoSmithKline Pharmaceuticals Alexa McCray Director, Lister Hill National Center for Biomedical Communications National Library of Medicine Lana Skirboll (via phone) Associate Director of Science Policy Office of the Director National Institutes of Health Harold C.Sox Editor Annals of Internal Medicine Melvyn L.Sterling Chair, Council on Scientific Affairs American Medical Association Robert Temple (via phone) Director, Office of Medical Policy Center for Drug Evaluation and Research U.S. Food and Drug Administration Elias Zerhouni (via phone) Director National Institutes of Health

OCR for page 50
Developing a National Registry of Pharmacologic and Biologic Clinical Trials: Workshop Summary Invited Experts Between December 1, 2004, and June 27, 2005 Alan Breier Vice President, Medical and Chief Medical Officer Eli Lilly and Company Catherine D.DeAngelis Editor-in-Chief Journal of the American Medical Association Jeffrey M.Drazen Editor-in-Chief New England Journal of Medicine Lawrence Hirsch Executive Director, Medical Communications Merck Research Laboratories John Hoey Editor Canadian Medical Association Journal Christine Laine Executive Secretary Annals of Internal Medicine Justin McCarthy General Counsel, Pfizer Global Research and Development Pfizer, Inc. Frank Rockhold Senior Vice President and Director, Biomedical Data Sciences GlaxoSmithKline Pharmaceuticals Research and Development Alfred Sandrock Vice President, Medical Research-Neurology Biogen Idec Ralph Smalling Vice President, Global Research and Development Policy Analysis Amgen Harold Sox Editor Annals of Internal Medicine

Representative terms from entire chapter:

clinical trials