Readying Your Clinical Trial For Linkage With Real-World Data

When it comes to recruiting patients for clinical trials and collecting the necessary data to assess the impact and safety of novel therapies, trial sponsors and sites are facing greater challenges than ever before. 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.