O'Quigley John, Conaway Mark
Inserm, Université Paris VI, Place Jussieu, 75005 Paris, France.
Stat Sci. 2010;25(2):202-216. doi: 10.1214/10-STS332.
During the last twenty years there have been considerable methodological developments in the design and analysis of Phase 1, Phase 2 and Phase 1/2 dose-finding studies. Many of these developments are related to the continual reassessment method (CRM), first introduced by O'Quigley, Pepe and Fisher (1990). CRM models have proven themselves to be of practical use and, in this discussion, we investigate the basic approach, some connections to other methods, some generalizations, as well as further applications of the model. We obtain some new results which can provide guidance in practice.
在过去二十年中,在1期、2期以及1/2期剂量探索研究的设计和分析方面,方法学有了显著发展。其中许多发展都与连续重新评估法(CRM)有关,该方法由奥奎利、佩佩和费舍尔于1990年首次提出。CRM模型已证明自身具有实际用途,在本次讨论中,我们将研究其基本方法、与其他方法的一些联系、一些推广以及该模型的进一步应用。我们获得了一些新结果,可为实践提供指导。