• 主题
高级搜索  >
历史搜索 清空历史
首页> 美国卫生研究院文献>other >Overview hurdles and future work in adaptive designs: perspectives from a National Institutes of Health-funded workshop
【2h】

Overview hurdles and future work in adaptive designs: perspectives from a National Institutes of Health-funded workshop

机译：概述障碍和未来适应性设计工作：从国家研究院的观点生资车间

代理获取
本网站仅为用户提供外文OA文献查询和代理获取服务，本网站没有原文。下单后我们将采用程序或人工为您竭诚获取高质量的原文，但由于OA文献来源多样且变更频繁，仍可能出现获取不到、文献不完整或与标题不符等情况，如果获取不到我们将提供退款服务。请知悉。
页面导航
  • 摘要
  • 著录项
  • 相似文献
  • 相关主题

摘要

BackgroundThe clinical trials community has a never-ending search for dependable and reliable ways to improve clinical research. This exploration has led to considerable interest in adaptive clinical trial designs, which provide the flexibility to adjust trial characteristics on the basis of data reviewed at interim stages. Statisticians and clinical investigators have proposed or implemented a wide variety of adaptations in clinical trials, but specific approaches have met with differing levels of support. Within industry, investigators are actively exploring the benefits and pitfalls associated with adaptive designs (ADs). For example, a Drug Information Association (DIA) working group on ADs has engaged regulatory agencies in discussions. Many researchers working on publicly funded clinical trials, however, are not yet fully engaged in this discussion. We organized the Scientific Advances in Adaptive Clinical Trial Designs Workshop to begin a conversation about using ADs in publicly funded research. Held in November of 2009, the 1½-day workshop brought together representatives from the National Institutes of Health (NIH), the Food and Drug Administration (FDA), the European Medicines Agency (EMA), the pharmaceutical industry, nonprofit foundations, the patient advocacy community, and academia. The workshop offered a forum for participants to address issues of ADs that arise at the planning, designing, and execution stages of clinical trials, and to hear the perspectives of influential members of the clinical trials community. The participants also set forth recommendations for guiding action to promote the appropriate use of ADs. These recommendations have since been presented, discussed, and vetted in a number of venues including the University of Pennsylvania Conference on Statistical Issues in Clinical Trials and the Society for Clinical Trials annual meeting.
机译：背景技术临床试验界一直在寻求可靠和可靠的方法来改善临床研究。这项探索引起了人们对适应性临床试验设计的极大兴趣，该设计提供了基于中期阶段审查的数据来调整试验特征的灵活性。统计学家和临床研究人员已经在临床试验中提出或实施了多种改编方法，但是具体方法遇到了不同程度的支持。在行业内，研究人员正在积极探索与自适应设计（AD）相关的收益和陷阱。例如，药品信息协会（DIA）的AD工作组已邀请监管机构进行讨论。但是，许多从事公共资助的临床试验的研究人员尚未完全参与此讨论。我们组织了“适应性临床试验设计的科学进展”研讨会，开始了有关在公共资助的研究中使用AD的对话。 2009年11月举行的为期1.5天的研讨会汇集了来自美国国立卫生研究院（NIH），食品药品管理局（FDA），欧洲药品管理局（EMA），制药业，非营利基金会，患者的代表宣传界和学术界。该研讨会为参与者提供了一个论坛，以解决在临床试验的规划，设计和执行阶段出现的AD问题，并聆听临床试验界有影响力成员的观点。与会者还提出了指导行动的建议，以促进适当使用广告。此后，这些建议已在包括宾夕法尼亚大学临床试验统计问题会议和临床试验协会年会在内的许多场所进行了介绍，讨论和审查。

著录项

相似文献

  • 外文文献
  • 中文文献
  • 专利
代理获取

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