MGTX经验：国际多中心临床试验规划与执行中的挑战
The MGTX experience: challenges in planning and executing an international, multicenter clinical trial.
作者信息
Aban Inmaculada B, Wolfe Gil I, Cutter Gary R, Kaminski Henry J, Jaretzki Alfred, Minisman Greg, Conwit Robin, Newsom-Davis John
机构信息
Department of Biostatistics, University of Alabama at Birmingham, 1665 University Boulevard, Birmingham, AL 35294-0022, United States.
出版信息
J Neuroimmunol. 2008 Sep 15;201-202:80-4. doi: 10.1016/j.jneuroim.2008.05.031.
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.
摘要
我们介绍了我们在计划和开展一项由美国国立卫生研究院（NIH）/国立神经疾病与中风研究所（NINDS）资助的重症肌无力胸腺切除术跨国研究方面的经验。我们强调了国际研究点所需的额外步骤，并分析和对比了使美国和非美国研究点完全符合监管要求所需的时间投入。结果显示，非美国研究中心获得监管批准的平均时间（平均13.4±0.96[校正后]个月）比美国研究点（9.67±0.74[校正后]个月；p=0.003，[校正后]t检验）长得多。非美国研究点的延迟主要归因于联邦范围保证认证和美国国务院审批。
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