非虚假设非中心法及其临床应用

目的本文提出一种非虚假设非中心法,并说明其临床应用.方法以非虚假设取代虚假设将经典非中心法加以扩展,以Monte Carlo方法展示其行为.结果当最小临床承认差量取零时,它还原为经典方法.其观测功效与预定功效吻合.结论这种方法适用于以治疗-对照差临床意义研究或临床等效性为目的临床试验的设计.

A Non-Central Procedure of the Non-Null Hypothesis and its Applications in Clinical Practice

Objective This paper proposes a non-central procedure of the non-null hypothesis and explains its applications in clinical practice.Methods It is derived from the classical non-central procedure using the non-null hypothesis in place of the null hypothesis.Its performance is exhibited by Monte Carlo method.Results It reduces to its classical counterpart when the minimal clinically relevant difference equals zero.Its observed power coincides with the prescribed power.Conclusion It is appropriate with the planning for clinical trials aimed at clinical significance of treatment-control difference or clinical equivalence.An example illustrates the methodology.