We propose a rule-based statistical design for combination dose-finding trials with two agents. The Ci3+3 design is an extension of the i3+3 design with simple decision rules comparing the observed toxicity rates and equivalence intervals that define the maximum tolerated dose combination. Ci3+3 consists of two stages to allow fast and efficient exploration of the dose-combination space. Statistical inference is restricted to a beta-binomial model for dose evaluation, and the entire design is built upon a set of fixed rules. We show via simulation studies that the Ci3+3 design exhibits similar and comparable operating characteristics to more complex designs utilizing model-based inferences. We believe that the Ci3+3 design may provide an alternative choice to help simplify the design and conduct of combination dose-finding trials in practice.
翻译：我们建议用两种物剂进行混合剂量调查试验时采用有章可循的统计设计。Ci3+3设计是i3+3设计的延伸,它使用简单的决定规则来比较观察到的毒性率和确定最大耐受剂量组合的等值间隔。Ci3+3由两个阶段组成,以便快速有效地探索剂量组合空间。统计推论仅限于用于剂量评估的乙型二胞胎模型,整个设计以一套固定规则为基础。我们通过模拟研究显示,Ci3+3设计展示了类似和可比的操作特征,而使用基于模型的推论来比较复杂的设计。我们认为,Ci3+3设计可以提供替代选择,帮助简化剂量调查组合试验的设计和操作。
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