...
  • 主题
高级搜索  >
历史搜索 清空历史
首页> 外文期刊>statistics in medicine >The use of external monitoring committees in clinical trials of the national institute of allergy and infectious diseases
【24h】

The use of external monitoring committees in clinical trials of the national institute of allergy and infectious diseases

机译：在国家过敏和传染病研究所的临床试验中使用外部监督委员会

获取原文
           
页面导航
  • 摘要
  • 著录项
  • 相似文献
  • 相关主题

摘要

AbstractRandomized clinical trials are being conducted and/or sponsored by all scientific divisions of the National Institute of Allergy and Infectious Diseases (NIAID). External committees to review the progress of ongoing trials and to make recommendations to the Institute concerning continuation or termination are an integral part of many of these trials. These committees have evolved considerably from thead hoccommittees, called together when a need arose, which were used beginning in the mid 1970s. Currently, there are many monitoring committees operating for NIAID‐sponsored trials. They function in a variety of ways, based partially on historical precedent and partially on the specialized requirements of the particular trial; there is no ‘standard operating procedure’ for the Institute, or even for divisions within the Institute. One of the major issues faced in establishing the data and safety monitoring board for AIDS treatment trials was access to the meetings of this board and to the reports of interim data that the board reviewed. After much discussion, procedures were established that restrict such access to a very limited group of programme and statistical centre staff. These procedures, while remaining controversial, appear necessary to ensure confidentiality and the integrity of the clinical trials pr
机译：摘要随机临床试验由美国国家过敏和传染病研究所（NIAID）的所有科学部门进行和/或赞助。审查正在进行的试验进展情况并就继续或终止向研究所提出建议的外部委员会是其中许多试验的组成部分。这些委员会从1970年代中期开始使用的在需要时召集起来的临时委员会有了很大的发展。目前，有许多监测委员会在为NIAID赞助的试验运作。它们以各种方式发挥作用，部分基于历史先例，部分基于特定审判的专门要求;研究所，甚至研究所内的各部门都没有“标准操作程序”。在建立艾滋病治疗试验数据和安全监测委员会时面临的主要问题之一是，能否参加该委员会的会议和该委员会审查的临时数据报告。经过多次讨论，制定了程序，将这种接触限制在非常有限的方案和统计中心工作人员群体中。这些程序虽然仍然存在争议，但对于确保临床试验的机密性和完整性似乎是必要的。

著录项

相似文献

  • 外文文献
  • 中文文献
获取原文

客服邮箱：kefu@zhangqiaokeyan.com

京公网安备：11010802029741号 ICP备案号：京ICP备15016152号-6 六维联合信息科技 (北京) 有限公司©版权所有

  • 客服微信

  • 服务号