Document Detail

The MGTX experience: challenges in planning and executing an international, multicenter clinical trial.
MedLine Citation:
PMID:  18675464     Owner:  NLM     Status:  MEDLINE    
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.
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:
Type:  Journal Article; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Journal of neuroimmunology     Volume:  201-202     ISSN:  0165-5728     ISO Abbreviation:  J. Neuroimmunol.     Publication Date:  2008 Sep 
Date Detail:
Created Date:  2008-09-22     Completed Date:  2008-12-23     Revised Date:  2010-08-06    
Medline Journal Info:
Nlm Unique ID:  8109498     Medline TA:  J Neuroimmunol     Country:  Netherlands    
Other Details:
Languages:  eng     Pagination:  80-4     Citation Subset:  IM    
Department of Biostatistics, University of Alabama at Birmingham, 1665 University Boulevard, Birmingham, AL 35294-0022, United States.
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MeSH Terms
Clinical Trials as Topic*
Ethics Committees, Research*
International Cooperation*
Myasthenia Gravis / surgery*
Retrospective Studies
Grant Support
5U01NS42685-03/NS/NINDS NIH HHS; U01 NS042685-03/NS/NINDS NIH HHS
Erratum In:
J Neuroimmunol. 2009 Dec 10;217(1-2):103

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