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