Approved on Paper, Failing in Practice: The Surrogate Endpoint Problem Quietly Undermining Drug Development
Regulatory agencies have long permitted drug approvals based on biomarker improvements rather than demonstrated patient benefit—a practice that has quietly allowed therapies with impressive trial data to deliver underwhelming real-world outcomes. As the pipeline of surrogate-based approvals grows, so does scrutiny over whether the shortcuts that accelerate market entry are ultimately serving patients or obscuring the limits of the medicines they trust. A closer examination of the structural pres