Semantic Bridges: Linking Study Design to Analytical Concepts

About this session

Part of Session 3, Track B: Digital/AI Foundations (Chair: Srinivasa Rao Mandava, Merck).

Traditional clinical trial protocols often contain ambiguities that can hinder digital data flow. This presentation introduces a framework and provides an in-depth exploration of Objective and Endpoint Standardization. This approach aims to bridge the gap between narrative study design and a structured, automated data flow, serving as the missing link between USDM and analytical concepts.
We will utilize standard codelists from the NCI and CDISC, along with the BEST (Biomarkers, EndpointS, and other Tools) resource developed by the FDA-NIH Biomarker Working Group. Through examples, we will demonstrate how to classify endpoints and establish a semantic layer, and show interconnectivity among activities, which will also help build the foundation for the analytical concepts.

Speakers

• BK

  Bhargav Koduru

  Medidata Solutions

  Speaker

• LM

  Luke Morgan

  Medidata Solutions

  Speaker