The MGTX experience: challenges in planning and executing an international, multicenter clinical trial
Inmaculada B Aban, Gil I Wolfe, Gary R Cutter, Henry J Kaminski, Alfred Jaretzki 3rd, Greg Minisman, Robin Conwit, John Newsom-Davis, Mgtx Advisory Committee, Inmaculada B Aban, Gil I Wolfe, Gary R Cutter, Henry J Kaminski, Alfred Jaretzki 3rd, Greg Minisman, Robin Conwit, John Newsom-Davis, Mgtx Advisory Committee
Abstract
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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Source: PubMed