Conflicts of interest in data monitoring of industry versus publicly financed clinical trials

被引：5

作者：

Lachin, JM

机构：

[1] George Washington Univ, Ctr Biostat, Dept Epidemiol & Biostat, Rockville, MD 20852 USA

[2] George Washington Univ, Ctr Biostat, Dept Stat, Rockville, MD 20852 USA

来源：

STATISTICS IN MEDICINE | 2004年 / 23卷 / 10期

关键词：

data monitoring in clinical trials; dualities of interest; FDA guidance;

D O I：

10.1002/sim.1787

中图分类号：

Q [生物科学];

学科分类号：

07 ; 0710 ; 09 ;

摘要：

The FDA Guidance, while highly appropriate for industry sponsored trials, need not be imposed on publicly (e.g. NIH) financed clinical trials. While the potential for conflicts of interest exist in the latter, they are in general manageable and pose an acceptable low risk of threatening the integrity of a study. However, the Guidance should heighten the awareness of all investigators in public trials to the potential for the appearance of conflicts and to the need for full and open participation in the management of dualities of interest. Copyright (C) 2004 John Wiley Sons, Ltd.

引用

页码：1519 / 1521

页数：3