Multi-Arm, Multi-Stage (MAMS) clinical trial designs allow for multiple therapies to be compared across a spectrum of clinical trial phases. MAMS designs can be categorized into several overarching design groups, including adaptive designs (AD) and multi-arm (MA) designs. Factorial clinical trials designs represent an additional group of designs which can provide increased efficiency relative to fixed, traditional designs. In this work, we explore design choices associated with Factorial Adaptive Multi-Arm Multi-Stage (FAST) designs, which represent the combination of factorial and MAMS designs. This category of trial can potentially offer benefits similar to both MAMS and factorial designs. This work is motivated by a proposed clinical trial under development.
翻译:多臂多阶段(MAMS)临床试验设计允许在多个临床试验阶段中比较多种疗法。MAMS设计可分为若干总体设计类别,包括适应性设计(AD)和多臂设计(MA)。阶乘临床试验设计作为另一类设计,相较于固定传统设计可提供更高的效率。本研究探讨了阶乘自适应多臂多阶段(FAST)设计的相关设计选择,该类设计融合了阶乘设计与MAMS设计的特点。此类试验可能兼具MAMS设计与阶乘设计的优势。本研究的开展源于一项正在开发中的临床试验提案。