Department of Biostatistics, University of North Carolina, Chapel Hill, NC 27599, USA.
J Clin Oncol. 2010 Jun 1;28(16):2796-801. doi: 10.1200/JCO.2009.25.0654. Epub 2010 May 3.
Joint models for longitudinal and survival data are particularly relevant to many cancer clinical trials and observational studies in which longitudinal biomarkers (eg, circulating tumor cells, immune response to a vaccine, and quality-of-life measurements) may be highly associated with time to event, such as relapse-free survival or overall survival. In this article, we give an introductory overview on joint modeling and present a general discussion of a broad range of issues that arise in the design and analysis of clinical trials using joint models. To demonstrate our points throughout, we present an analysis from the Eastern Cooperative Oncology Group trial E1193, as well as examine some operating characteristics of joint models through simulation studies.
联合纵向和生存数据模型在许多癌症临床试验和观察性研究中特别相关，在这些研究中，纵向生物标志物（例如，循环肿瘤细胞、对疫苗的免疫反应和生活质量测量）可能与事件时间（例如，无复发生存或总生存）高度相关。在本文中，我们将对联合建模进行介绍性概述，并对使用联合模型进行临床试验的设计和分析中出现的广泛问题进行一般性讨论。为了在整个过程中说明我们的观点，我们将展示来自东部合作肿瘤学组试验 E1193 的分析结果，并通过模拟研究检查联合模型的一些操作特性。
