Strategies for including patients recruited during interim analysis of clinical trials

被引:11
作者
Faldum, Andreas [1 ]
Hommel, Gerhard [1 ]
机构
[1] Johannes Gutenberg Univ Mainz, Inst Med Biostat Epidemiol & Informat, D-55101 Mainz, Germany
关键词
adaptive design; average sample size; conditional error function; design modi. cation; group sequential design; interim patients; maximum sample size; overrunning; power; repeated interim analysis;
D O I
10.1080/10543400701645439
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
In clinical trials a periodical check of safety and efficacy data is often needed. For organizational reasons it is rarely desirable to stop a trial during such an interim analysis. Therefore, new study patients are included in the trial while the interim analysis is ongoing. Disregarding the additional information provided by these interim patients would be unsatisfactory, especially for an office of regulatory affairs. Consequently, the rules for group sequential or adaptive decisions must be adjusted to the recruitment of interim patients. In this paper, two strategies for modifying study designs to consider the analysis of interim patients are proposed.
引用
收藏
页码:1211 / 1225
页数:15
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