Problems in dealing with missing data and informative censoring in clinical trials

被引:125
|
作者
Shih, WCJ [1 ]
机构
[1] Univ Med & Dent New Jersey, Sch Publ Hlth, Div Biometr, New Brunswick, NJ 08903 USA
[2] Univ Med & Dent New Jersey, Robert Wood Johnson Med Sch, Canc Inst New Jersey, New Brunswick, NJ USA
关键词
informative missing data; intent to treat; longitudinal study; missing completely at random;
D O I
10.1186/1468-6708-3-4
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
A common problem in clinical trials is the missing data that occurs when patients do not complete the study and drop out without further measurements. Missing data cause the usual statistical analysis of complete or all available data to be subject to bias. There are no universally applicable methods for handling missing data. We recommend the following: (1) Report reasons for dropouts and proportions for each treatment group; (2) Conduct sensitivity analyses to encompass different scenarios of assumptions and discuss consistency or discrepancy among them; (3) Pay attention to minimize the chance of dropouts at the design stage and during trial monitoring; (4) Collect post-dropout data on the primary endpoints, if at all possible; and (5) Consider the dropout event itself an important endpoint in studies with many.
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页数:7
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