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In randomized clinical trials it is rather rare that all the subjects who entered the trial complete the trial schedule given in the protocol, and more or less"incomplete cases", called exclusions, withdrawals and dropouts, often occur. How to deal with the data of these"incomplete cases"may critically influence the conclusion to be reached. The problem is particularly important in the clinical evaluation of new drugs. There is, however, no generally agreed upon, definite guideline for the handling of these"incomplete cases".Since they occur in various forms it seems that uniform handling of the problem is not appropriate and handling corresponding to the nature of each will be necessary. In this article we tentatively define terms which classify the"incomplete cases"and discuss practical and valid ways to deal with the problem depending upon the purpose and character of the study.
一般社団法人日本臨床薬理学会の論文