近年來相等性或非劣性研究已普遍的應用在臨床試驗上，目的是為了證明，當給予特定的邊界時，新的試驗依然能夠保有與標準試驗相同的效果，但是新的試驗卻可以提供標準試驗所沒有的特性，像是更具安全性、具有較少的毒性、在管理上較方便性、或者是價格較便宜等。一般來說，相等性或非劣性研究應用在二元資料時，有三種不同的統計評估方法，分別是反應比率的差異、反應比率的比值、以及勝算比。本篇論文中，將會利用模擬的方法來討論與比較三種不同方法的經驗型一誤差與檢定力；此外，亦提出在配對試驗設計下，勝算比之受限制的最大概似估計式。最後，用模擬比較與代入例子於所提的方法中。

　　In recent years, equivalence or non-inferiority studies have been applied to clinical trial. For equivalence or non-inferiority trials, the goal is to show that the new treatment can maintain similar treatment effects as compared to that of standard treatment by a pre-specified margin. New treatments have been developed because they offer better safety, less toxic, easier to administer or less expensive. Parallel designs and matched-pair designs generate independent and paired binary endpoints. Based on binary endpoints three difference criteria were proposed to evaluate equivalence or non-inferiority. They are difference in proportion, ratio of proportion, and odds ratio. We conducted a simulation to compare the performance of different methods based on these three measures in terms of size and power. In addition, we derived a new test based on restricted maximum likelihood estimator (RMLE) for the odds ratio. Its properties are also investigated by simulation. A numerical method illustrates the proposed method.

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