The MGTX experience: challenges in planning and executing an international, multicenter clinical trial.
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.
Aban
Inmaculada B
IB
Department of Biostatistics, University of Alabama at Birmingham, 1665 University Boulevard, Birmingham, AL 35294-0022, United States. caban@uab.edu
Wolfe
Gil I
GI
Cutter
Gary R
GR
Kaminski
Henry J
HJ
Jaretzki
Alfred
A
Minisman
Greg
G
Conwit
Robin
R
Newsom-Davis
John
J
D002986:Clinical Trials as Topic; D028744:Ethics Committees, Research; D006801:Humans; D007391:International Cooperation; D009157:Myasthenia Gravis / Q000601:surgery*; D012189:Retrospective Studies; D013934:Thymectomy