Implementing the EGASIS trial, an international multicenter acute intervention trial in stroke

被引：10

作者：

van Raak, L

Hilton, A

Kessels, F

Lodder, J

机构：

[1] Univ Hosp Maastricht, Dept Neurol, Maastricht, Netherlands

[2] Univ Hosp Maastricht, Dept Clin Epidemiol & Med Technol Assessment, Maastricht, Netherlands

来源：

CONTROLLED CLINICAL TRIALS | 2002年 / 23卷 / 01期

关键词：

international multicenter clinical trial; trial implementation; EGASIS; funding of clinical trials; ethical approval; informed consent; shipping trial medication; trial insurance;

D O I：

10.1016/S0197-2456(01)00186-6

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

1001 ;

摘要：

This paper describes some of the problems that were encountered during implementation of the Early GABA-ergic Activation Study In Stroke (EGASIS), a large international multicenter clinical trial evaluating the neuroprotective effect of diazepam in acute stroke. The focus is on obtaining funding for such a large international nonprofit trial, getting approval from all national and local ethics committees, shipping trial medication, and trial insurance. For each topic the specific problems and ways in which they were solved are described. Several recommendations for facilitating the running of a large international multicenter clinical trial such as EGASIS are made. (C) 2002 Elsevier Science Inc. All rights reserved.

引用

页码：74 / 79

页数：6

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