| The MGTX experience: challenges in planning and executing an international, multicenter clinical trial. | |
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MedLine Citation:
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PMID: 18675464 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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We present our experience planning and launching a multinational, NIH/NINDS funded study of thymectomy in myasthenia gravis. We highlight the additional steps required for international sites and analyze and contrast the time investment required to bring U.S. and non-U.S. sites into full regulatory compliance. Results show the mean time for non-U.S. centers to achieve regulatory approval was significantly longer (mean 13.4+/0.96 [corrected] months) than for U.S. sites (9.67+/0.74 [corrected] months; p=0.003, [corrected] t-test). The delay for non-U.S. sites was mainly attributable to Federalwide Assurance certification and State Department clearance. |
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Authors:
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Inmaculada B Aban; Gil I Wolfe; Gary R Cutter; Henry J Kaminski; Alfred Jaretzki; Greg Minisman; Robin Conwit; John Newsom-Davis; |
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Publication Detail:
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Type: Journal Article; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: Journal of neuroimmunology Volume: 201-202 ISSN: 0165-5728 ISO Abbreviation: J. Neuroimmunol. Publication Date: 2008 Sep |
Date Detail:
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Created Date: 2008-09-22 Completed Date: 2008-12-23 Revised Date: 2010-08-06 |
Medline Journal Info:
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Nlm Unique ID: 8109498 Medline TA: J Neuroimmunol Country: Netherlands |
Other Details:
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Languages: eng Pagination: 80-4 Citation Subset: IM |
Affiliation:
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Department of Biostatistics, University of Alabama at Birmingham, 1665 University Boulevard, Birmingham, AL 35294-0022, United States. caban@uab.edu |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Clinical Trials as Topic* Ethics Committees, Research* Humans International Cooperation* Myasthenia Gravis / surgery* Retrospective Studies Thymectomy* |
| Grant Support | |
ID/Acronym/Agency:
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5U01NS42685-03/NS/NINDS NIH HHS; U01 NS042685-03/NS/NINDS NIH HHS |
| Comments/Corrections | |
Erratum In:
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J Neuroimmunol. 2009 Dec 10;217(1-2):103 |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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