Penel N, Fournier C, Stéphanie C
Centre Oscar-Lambret, Département de Cancérologie Générale, 3 Rue Frédéric-Combemale, 59000 Lille, France.
Bull Cancer. 2010 Jan;97(1):55-63. doi: 10.1684/bdc.2010.1016.
We propose here a general review of current questions related to early trials, including the choice of the primary endpoint, role of bayesian designs, role of stratification and randomization for phase 2 trials, patient selection, and new designs for phase 1 and phase 0 trials. We also discuss the difficulties to apply such methodologies to molecular targeted therapies development.
我们在此对与早期试验相关的当前问题进行全面综述,包括主要终点的选择、贝叶斯设计的作用、2期试验分层和随机化的作用、患者选择以及1期和0期试验的新设计。我们还讨论了将这些方法应用于分子靶向治疗开发的困难。