Linking clinical trial participants to their U.S. real-world data through tokenization: A practical guide

Area of Science:

• Health Informatics
• Clinical Trials
• Real-World Data Analytics

Background:

• Real-world data (RWD) offers insights into patient experiences and treatment effects beyond clinical trials.
• Electronic health record (EHR) data integration is common in trials but faces challenges due to data fragmentation.
• Linking disparate RWD sources and trial data is crucial for comprehensive evidence generation.

Purpose of the Study:

• To describe the applications of linking real-world data (RWD) with clinical trial data.
• To highlight the benefits of RWD linkage for clinical development and real-world decision-making.
• To address operational considerations for privacy-preserving RWD linkage in clinical research.

Main Methods:

• Utilizing tokenization for privacy-preserving linkage of RWD and clinical trial data.
• Employing privacy-preserving record linkage systems with accuracy and precision metrics.
• Implementing participant consent management and site-level training for RWD access.

Main Results:

• RWD linkage enhances the interpretability and generalizability of clinical trial results.
• It aids in addressing missing data and losses to follow-up in trials.
• Extends patient follow-up beyond trial completion and characterizes trial applicability to diverse populations.

Conclusions:

• Linking RWD to clinical trial data bridges evidence gaps and improves the generalizability of trial findings.
• Privacy-preserving linkage methods are essential for ethical and effective data integration.
• Operational readiness, including consent and training, is key for successful RWD linkage implementation in trials.