A Workflow to Assess Treatment Effect Heterogeneity in Drug Development for Clinical Trial Sponsors скачать в хорошем качестве

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

We are pleased to announce an exciting seminar on clinical trial innovation as part of the ISBS Webinar Series. The seminar, titled "WATCH: A Workflow to Assess Treatment Effect Heterogeneity in Drug Development for Clinical Trial Sponsors" will be held on April 4, 2025, 10am-11am EDT, featuring distinguished speaker Dr. Kostas Sechidis from Novartis Pharma AG. Abstract: In this talk we will present a Workflow for Assessing Treatment effeCt Heterogeneity (WATCH) in clinical drug development. Assessing treatment effect heterogeneity (TEH) in clinical trials is crucial, as it provides insights into the variability of treatment responses among patients, which may influence important decisions by related to drug development. Furthermore, it can lead to personalized medicine, as it allows for the tailoring of treatments to individual patient characteristics. WATCH is designed to address the challenges in investigating TEH in randomized clinical trials, where sample size and multiplicity can limit the reliability of findings. The proposed workflow includes four steps: Analysis Planning, Initial Data Analysis and Dataset Creation, TEH Exploration, and Multidisciplinary Assessment. The central analytical step involves exploring TEH by addressing three key questions: the strength of evidence against homogeneity, identification of observed effect modifiers, and the impact of treatment effect changes on identified covariates. In this presentation, we will also discuss our work on using ML/AI to address these questions, specifically by estimating the individualised treatment effects derived from a doubly robust learner as a key driver.