Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
3065162 | Journal of Neuroimmunology | 2008 | 5 Pages |
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 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.
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Authors
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,