Shao Jun, Jordan David C, Pritchett Yili L
Department of Statistics, University of Wisconsin, Madison, Wisconsin 53706, USA.
J Biopharm Stat. 2009 Jul;19(4):672-84. doi: 10.1080/10543400902964118.
In some longitudinal drug studies, regulatory agencies suggest baseline observation carry forward (BOCF) as a method of handling patient dropout, despite the existence of many criticisms to BOCF. The reason for using BOCF is not clear to many users who either treat BOCF as an imputation method or consider BOCF to be "conservative" in the sense that it allows treatment effect to be evaluated with a severe penalty for dropouts. In this article we address the following questions and issues: What is the reason for using BOCF? Is BOCF a conservative approach to assessing drug efficacy? Is BOCF reasonable? If not, what are the alternatives? Our discussions are based on both theoretical and practical viewpoints.
在一些纵向药物研究中，尽管对基线观察值结转（BOCF）存在诸多批评，但监管机构仍建议将其作为处理患者退出试验情况的一种方法。许多使用者并不清楚采用BOCF的原因，他们要么将BOCF视为一种插补方法，要么认为BOCF是“保守的”，因为它允许在评估治疗效果时对退出试验者施以严厉惩罚。在本文中，我们探讨以下问题：使用BOCF的原因是什么？BOCF是评估药物疗效的保守方法吗？BOCF合理吗？如果不合理，有哪些替代方法？我们的讨论基于理论和实践两个视角。
