Clinical trials vs real-world data

Randomized clinical trials (RCTs) are the cornerstone of modern oncology and are considered the «gold standard» for evaluating the efficacy of anticancer agents. However, as experience accumulates, the gap between outcomes obtained within the clinical trials and real-world outcomes observed in routine oncological practice is becoming increasingly apparent. On one hand, this discrepancy is driven by strict – and largely artificial – eligibility criteria and the prognostic heterogeneity of the real-world patient population; on the other hand, it reflects the growing influence of the pharmaceutical industry on trial design, endpoint selection, and interpretation of results. This article 
presents a critical analysis of these issues, drawing on data from key studies completed or published in 2024–2025.