Using De-Identified Linked Real-World Data To Create An External Control Arm

A Pharmaceutical company designed its Phase II study of a novel agent to treat metastatic non-small cell lung cancer driven by a rare subtype of EGFR genetic mutation. This type of lung cancer only affected a small subset of EGFR patients, therefore designing studies and finding patients for clinical trials was difficult. The client decided that constructing a control arm out of real-world electronic health record data would be the best approach to the trial. This case study examines how utilizing a platform that allowed them to collect data across three vendors that represented unique patients proved successful and enabled the company to move forwards with the Phase II pivotal trial.