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Statistics > Applications
Title: WATCH: A Workflow to Assess Treatment Effect Heterogeneity in Drug Development for Clinical Trial Sponsors
(Submitted on 1 May 2024)
Abstract: 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.
Submission history
From: Konstantinos Sechidis [view email][v1] Wed, 1 May 2024 20:47:51 GMT (642kb,D)
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