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II期临床试验设计方案及其C++编程

A DESIGN OF PHASE II CLINICAL TRIALS AND ITS C++ PROGRAMMING
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摘要 II期临床试验通常用于新的治疗方法疗效的初步评估.传统的二阶段设计只考虑总的响应这一个解释变量.陆盈等人提出了一种新的试验方案,同时考察总的响应和完全响应两个变量,他们的试验设计为II期临床试验提供了更多更好的选择.但是相应的计算程序是用S-P lus编写的,运行时间过长.改用C++编程,制作的软件计算速度相对较快,而且在W indows环境下就可运行,这将方便广大医学工作者临床使用. Phase II clinical trials are usually used for initial evaluation of the therapeutic efficacy of a new treatment regimen.The traditional two-stage design just focused on the total response.Lu Ying and his colleagues have considered both the total response and the complete response,and proposed a new practical design,which provides more and/or better choices for clinical trials.However,they compiled the computer programming with S-Plus,which would cost a lot of time.C++ is used for the programming.The soft can run directly in Windows in quicker speed than S-Plus.It will be very convenient for practical use of clinical physicians.
作者 金华 陈亮
出处 《华南师范大学学报(自然科学版)》 CAS 2006年第1期1-5,共5页 Journal of South China Normal University(Natural Science Edition)
关键词 Ⅱ期二阶段临床试验设计 总响应 完全响应 C++编程 phase II clinical trials total response complete response C++ programming
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参考文献3

  • 1SIMON R.Optimal two-stage designs forphase Ⅱ clinical trials[J].Controlled Clinical Trials,1989,10:1-10.
  • 2LU Y,JIN H,LAMBORN KR.A design of phase Ⅱ cancer trials using total and completeresponse endpoints[J].Statistics in Medicine,2005,24(20):3155-3170.
  • 3PANAGEAS KS,SMITH A,GONEN M,et al.An optimal two-stage phase Ⅱ design utilizingcomplete and partial response information separately[J].Controlled ClinicalTrials,2002,23:367-379.

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