The MGTX experience: Challenges in planning and executing an international, multicenter clinical trial

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• 作者：Inmaculada B. Aban ; Gil I. Wolfe ; Gary R. Cutter ; Henry J. Kaminski ; Alfred Jaretzki III ; Greg Minisman ; Robin Conwit ; John Newsom-Davis ; MGTX Advisory Committee
• 关键词：Myasthenia gravis ; Thymectomy ; Regulatory approval
• 刊名：Journal of Neuroimmunology
• 出版年：2008
• 出版时间：15 September 2008
• 年：2008
• 卷：201-202
• 期：Complete
• 页码：80-84
• 全文大小：207 K

文摘

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 months) than for U.S. sites (9.67 ± 0.74 months; p = 0.0175, t-test). The delay for non-U.S. sites was mainly attributable to Federalwide Assurance certification and State Department clearance.