In E14, the recommended metric to analyze for a cross-over study is the largest time-matched mean difference between the drug and placebo （baseline-adjusted） over the collection period.〔【出典】ICHガイドライン 〕
Within this general description there is a wide variety of designs that can be used successfully: parallel or cross-over designs （see ICH E9）, single fixed dose or titration in the active drug group, several fixed doses.〔【出典】ICHガイドライン 〕
The choice of baseline is influenced by whether the study is parallel or cross-over.〔【出典】ICHガイドライン 〕
In contrast, in a cross-over study a time-matched baseline is usually not necessary because adjustments for subject- and study-specific diurnal variation are implicit by design in the assessment of time-matched drug-placebo differences in QT/QTc effect.〔【出典】ICHガイドライン 〕
For a crossover design, for example, there should be consideration, among other things, of the likelihood of spontaneous change in the disease and of carry-over effects of treatment during the study.〔【出典】ICHガイドライン 〕
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In addition to the type of control, other critical design features that may need discussion are use of a cross-over design and selection of patients with particular prior history, such as response or non-response to a specific drug or member of a drug class.〔【出典】ICHガイドライン 〕