Review of: "Trust and Trade: Ethical Reflections on Patient Trust and the Monetisation of Real-World Data"

This commentary addresses a critical blind spot in the current pharmaceutical regulatory landscape.As the FDA and EMA increasingly rely on Real-World Evidence (RWE) for regulatory decision-makingspanning from initial market authorization to post-market safety surveillance-the governance frameworks have largely focused on methodological rigor and data integrity (e.g., ALCOA+ principles).The author correctly identi es that while we have robust standards for how data is analyzed (STaRT-RWE, HARPER), we lack a cohesive framework for the relational ethics of its secondary use.