Statistical methodology for the adaptive design and analysis of clinical trials

临床试验适应性设计和分析的统计方法

• 批准号: 371501-2009
• 负责人: Yi, Yanqing
• 金额: $ 1.09万
• 依托单位: Memorial University of Newfoundland
• 依托单位国家: 加拿大
• 项目类别: Discovery Grants Program - Individual
• 财政年份: 2009
• 资助国家: 加拿大
• 起止时间: 2009-01-01 至 2010-12-31
• 项目状态: 已结题
• 来源: https://www.nserc-crsng.gc.ca/ase-oro/Details-Detailles_eng.asp?id=434848
• 关键词: Statistical; methodology; adaptive; design; analysis

A randomized clinical trial is an efficient tool to draw a valid conclusion on a new medical intervention to benefit future patients outside the trial (collective ethics). Balanced randomization is considered as the gold standard in clinical trials. However, this randomization raises ethical concerns because half of the participants are allocated to the inferior intervention and individual ethics is sacrificed. According to the personal care principle, it is difficult or impossible to implement randomization in a clinical trial considering the well-being of patients in the trial (individual ethics). Response adaptive designs are proposed to alleviate the tension between the collective and individual ethics.

随机临床试验是一种有效的工具，可以对新的医疗干预措施得出有效的结论，使试验外的未来患者受益（集体伦理）。平衡随机化被认为是临床试验的金标准。然而，这种随机化引起了伦理问题，因为一半的参与者被分配到劣干预和个人道德牺牲。根据个人护理原则，考虑到试验中患者的福祉（个体伦理），在临床试验中很难或不可能实施随机化。反应自适应设计的提出是为了缓解集体和个人伦理之间的紧张关系。