Data Standardization to Facilitate Comparison of Real World Data and Clinical Trial Data

• Activity Number: 412 - Incorporation of Real-World Evidence in Clinical Trial Designs and Associated Statistical Methodologies
• Type: Topic Contributed
• Date/Time: Wednesday, August 5, 2020 : 1:00 PM to 2:50 PM
• Sponsor: Section for Statistical Programmers and Analysts
• Author(s): Aaron Galaznik*
• Companies: Acorn AI, a Medidata Company
• Keywords: clinical trial ; real world data; data standardization; common data model

Abstract

The promise of real-world data lies in its high external validity for characterizing patient experience as it exists in real life, across a heterogeneous breadth of diseases, patient types, and treatments. Pooled clinical trial data can effectively complement real world data by providing a source with high internal validity, consistency of data collection, and outcomes assessment. We present here how common data standards, data models and medical vocabularies can facilitate the comparison of pooled clinical trial and real-world data cohorts.