This paper proposes a Workflow for Assessing Treatment effeCt Heterogeneity (WATCH) in clinical drug development targeted at clinical trial sponsors. The workflow is designed to address the challenges of investigating treatment effect heterogeneity (TEH) in randomized clinical trials, where sample size and multiplicity limit the reliability of findings. The proposed workflow includes four steps: Analysis Planning, Initial Data Analysis and Analysis Dataset Creation, TEH Exploration, and Multidisciplinary Assessment. The workflow aims to provide a systematic approach to explore treatment effect heterogeneity in the exploratory setting, taking into account external evidence and best scientific understanding.

翻译：本文提出了一种面向临床试验申办方的临床药物开发中处理效应异质性（TEH）评估工作流（WATCH）。该工作流旨在解决随机临床试验中TEH研究面临的挑战，这些挑战源于样本量和多重性问题限制了研究结果的可靠性。所提出的工作流包含四个步骤：分析规划、初始数据分析与分析数据集创建、TEH探索以及多学科评估。该工作流旨在提供一种系统化的方法，在探索性场景下考量外部证据与最佳科学理解，从而对处理效应异质性进行探究。