Chuang-Stein et al. proposed a method for benefit-risk assessment by formulating a five-category multinomial random variable with the first four categories as a combination of benefit and risk, and the fifth category to include subjects who withdraw from study. In this article, we subdivide the single withdrawal category into four sub-categories to consider withdrawal for different reasons. To analyze eight-category data, we propose a two-level multivariate-Dirichlet Model to identify benefit-risk measures at the population level. For individual benefit-risk, we use a log-odds ratio model with Dirichlet process prior. Two methods are applied to a hypothetical clinical trial data for illustration.

中文翻译：

---

使用纵向数据在临床研究中进行收益风险评估的贝叶斯方法。

Chuang-Stein等。提出了一种利益风险评估方法，该方法通过制定一个五类多项式随机变量，其中前四类为利益和风险的组合，第五类包括退出研究的对象。在本文中，我们将单个提款类别细分为四个子类别，以出于不同原因考虑提款。为了分析八类数据，我们提出了一个两级多元Dirichlet模型来识别人口水平上的利益风险度量。对于个人利益风险，我们先使用Dirichlet过程的对数比模型。将两种方法应用于假设的临床试验数据以进行说明。