• 主题
高级搜索  >
历史搜索 清空历史
首页> 外文期刊>BMC Medical Research Methodology >Three steps to writing adaptive study protocols in the early phase clinical development of new medicines
【24h】

Three steps to writing adaptive study protocols in the early phase clinical development of new medicines

机译：在新药临床早期开发中编写适应性研究方案的三个步骤

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

摘要

This article attempts to define terminology and to describe a process for writing adaptive, early phase study protocols which are transparent, self-intuitive and uniform. It provides a step by step guide, giving templates from projects which received regulatory authorisation and were successfully performed in the UK. During adaptive studies evolving data is used to modify the trial design and conduct within the protocol-defined remit. Adaptations within that remit are documented using non-substantial protocol amendments which do not require regulatory or ethical review. This concept is efficient in gathering relevant data in exploratory early phase studies, ethical and time- and cost-effective.
机译：本文试图定义术语，并描述编写自适应，早期研究协议的过程，该协议应透明，自觉且统一。它提供了分步指南，提供了已获得监管授权并在英国成功执行的项目的模板。在适应性研究期间，不断发展的数据将用于修改试验设计并在协议定义的职权范围内进行。该职权范围内的修改使用非实质性协议修订案进行了记录，不需要进行法规或道德审查。该概念可有效地收集具有道德，时间和成本效益的探索性早期研究中的相关数据。

著录项

相似文献

  • 外文文献
  • 中文文献
  • 专利
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