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. 2008 Sep 15:201-202:80-4.
doi: 10.1016/j.jneuroim.2008.05.031.

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

Inmaculada B Aban  1 , Gil I Wolfe, Gary R Cutter, Henry J Kaminski, Alfred Jaretzki 3rd, Greg Minisman, Robin Conwit, John Newsom-Davis; Mgtx Advisory Committee
Affiliations

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

Inmaculada B Aban et al. J Neuroimmunol. .

Erratum in

  • J Neuroimmunol. 2009 Dec 10;217(1-2):103

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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Figures

Figure 1
Figure 1
Average Number of Months until Completion of Study Prerequisites
Figure 2
Figure 2
Proportion of Centers Completing Study Prerequisites
See this image and copyright information in PMC

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