How-to Guide: Readying Your Clinical Trial for Linkage with Real-World Data

The near ubiquity of real-world data (RWD) sources such as electronic health records, claims, and lab data has prompted sponsors to consider RWD’s role in study programs, and regulatory bodies to issue guidance on their use in clinical development.

While some types of RWD have been used widely for many years, RWD has remained isolated from the detailed study participant data collected during the course of a clinical trial.

Key considerations for when a trial is ready or appropriate for tokenization include:

• Study flexibility
• Patient consent and education
• Site education and operations
• Real-world data access and linkage