标题: 连续型变数之贝氏二阶段第二期临床试验设计
Bayesian Two-Stage Designs for Phase II Clinical Trials with Continuous Endpoints
作者: 陈思璇
Chen, Szu-Hsuan
萧金福
Hsiao, Chin-Fu
统计学研究所
关键字: 二阶段临床测试;贝氏方法;phase II clinical trials;two-stage design;Bayesian approach
公开日期: 2013
摘要: 制药发展是需要长时间和花费的一个过程,而许多机构在执行药物临床测试时,药物在相对较晚的程序中才宣告失败停止,因此基于在侦测药物效能上使用较快且可靠的方法并且减少受试者人数和试验所需时间,研发出新式临床策略或方法设计,其中的设计是更加有效率不论是在执行上或是花费上在侦测有可能性的药物,而新设计在制药发展中有着迫切的需要。在临床试验第二阶段(phase II clinical trials),其中两阶段(two-stage)或是多阶段(multiple-stage) 无对照组试验设计多采用frequentist的统计方法,另一方面,相对于frequentist另有贝氏(Bayesian) 统计方法,贝氏方法可将相关的先前资讯纳入临床结果分析之中,可使之更加符合直觉并且对试验更有帮助。在此篇论文当中,针对连续型变数提出两种贝氏二阶段药物效用监控设计,并针对此二设计提出数值范例来示范此二贝氏设计并且与frequentist的统计方法做出比较。
Pharmaceutical development is a lengthy and expensive process and many of these agents fail relatively late in that process. Hence, there is an urgent need of new strategies and methodology for efficient and cost-effective designs to screen potential candidates based on the idea of the proof of the concept for efficacy in a rapid and reliable manner to minimize the total sample size and hence to shorten the duration of the trials. In phase II clinical trials, two-stage or multiple-stage designs with no control group have been proposed based on frequentist statistical approaches. Alternatively, Bayesian methods incorporating relevant prior information into the analysis of the trial results may be more intuitive and helpful. In this thesis, two Bayesian two-stage screening designs based on continuous efficacy endpoints are proposed. Numerical example is presented to illustrate the Bayesian approach. Comparisons with other frequentist approaches are also made.
URI: http://140.113.39.130/cdrfb3/record/nctu/#GT070052606
http://hdl.handle.net/11536/71497
显示于类别:Thesis


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