WATCH Workflow to Assess Treatment Effect Heterogeneity in Drug Development for Clinical Trial Sponsors

Music City Center 

We proposed a Workflow for Assessing Treatment effeCt Heterogeneity (WATCH) in clinical drug
development targeted at clinical trial sponsors. WATCH 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 offers a general
overview of how treatment effects vary by baseline covariates in the observed data, and guides interpretation of
the observed findings based on external evidence and best scientific understanding.

treatment effect heterogeneity