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The analysis of clinical trials concerns itself with a large number of related topics including * the choice of an estimand of interest that is closely linked to the objectives of the trial, * the choice and definition of analysis sets, * the choice of an appropriate statistical model for the type of data being studied, * appropriate accounting for the treatment assignment process, * handling of missing data, * handling of multiple comparisons or endpoints, * accounting for interim analyses and trial adaptations, * and appropriate data presentation. One basic guidance document on this topic is the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use guidance E9.〔(International Conference on Harmonization, Guidance for Industry E9, Statistical Principals for Clinical Trials ), 1998〕 == Choice of analysis set == Failure to include all participants in the analysis may bias the trial results. Most trials do not yield perfect data, however. "Protocol violations" may occur, such as when the patients do not receive the full intervention or the correct intervention or a few ineligible patients are randomly allocated in error. Despite the fact that the most clinical trials are carefully planned, many problems can occur during the conduct of the study. Some examples are as follows: * Patients who do not satisfy the inclusion and/or exclusion criteria are included in the trial, * A patient is randomized to Treatment A, but is treated with Treatment B, * Some patients drop out from the study, or * Some patients are not compliant, that is, do not take their medication as instructed, and so on. 抄文引用元・出典: フリー百科事典『 ウィキペディア（Wikipedia）』 ■ウィキペディアで「Analysis of clinical trials」の詳細全文を読む スポンサード リンク
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