Kaufmann Nathalie C, Pereira Philippe L
Cardiovascular and Interventional Radiological Society of Europe, Neutorgasse 9/6, 1010, Vienna, Austria.
Next Research GmbH, Neutorgasse 9/4a, 1010, Vienna, Austria.
Cardiovasc Intervent Radiol. 2025 Sep 25. doi: 10.1007/s00270-025-04179-4.
Randomised controlled trials (RCTs) have traditionally been regarded as the gold standard in evidence-based medicine, providing a high level of evidence. However, mounting complexities, ranging from ethical issues and logistical barriers to rapid technological evolutions, have sparked interest in alternative or complementary evidence-generation methods. Real-world evidence (RWE) from large, well-designed research projects is increasingly viewed as powerful tools. Although RWE is sometimes perceived as "less robust" compared to RCTs due to potential biases, recent advances in study design, data capture, and analytical frameworks have highlighted its potential for shaping clinical practice and informing regulatory decisions. This article discusses the benefits and challenges of RWE within interventional oncology and explores whether it is merely "better than nothing" or indeed represents a key pillar of the future of clinical research.
传统上，随机对照试验（RCTs）被视为循证医学的金标准，能提供高水平的证据。然而，从伦理问题、后勤障碍到快速的技术演变等日益增加的复杂性，引发了人们对替代或补充证据生成方法的兴趣。来自大型、精心设计的研究项目的真实世界证据（RWE）越来越被视为强大的工具。尽管由于潜在偏差，RWE有时被认为比RCTs“可靠性稍低”，但研究设计、数据收集和分析框架方面的最新进展凸显了其在塑造临床实践和为监管决策提供信息方面的潜力。本文讨论了RWE在介入肿瘤学中的益处和挑战，并探讨了它仅仅是“聊胜于无”，还是确实代表了临床研究未来的关键支柱。
