In this repo we provide an implementation of the 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.
WATCH was introduced in Sechidis et al. (2024), and in the current repo we provide an implementation based on the double robust learner, as it was described in the Appendix.
- Konstantinos (Kostas) Sechidis, kostas.sechidis@novartis.com
- Sophie Sun, sophie.sun@novartis.com
- Yao Chen, yao.chen@novartis.com
- Jiarui Lu, jiarui.lu@novartis.com
- Cong Zhang, cong.zhang@novartis.com
- Björn Bornkamp, bjoern.bornkamp@novartis.com