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摘要: 近年来,在医药卫生领域,利用真实世界数据生成真实世界证据的研究方法在药品研发、审批、适应证拓展等领域取得广泛的关注和认可,开展真实可信、高质量的真实世界研究证据(real world evidence,RWE),已成为循证医学的一个重要发展方向。本文介绍了近年来国内外关于结直肠癌真实世界研究的现状,将真实世界研究(real world research/study,RWS)与相应的随机对照研究(randomized controlled trial,RCT)的meta分析结果进行对比和评价,以阐述RWS的特征、研究方法、相对于传统RCT研究的优势,并归纳其在肠癌领域的应用现状。在此基础上,对RWS在结直肠癌临床研究中的价值和前景进行总结,为后续研究提供新的思路。Abstract: In recent years, in the medical and health field, the research method of generating real world evidence (RWE) using real-world data has gained increasing attention and recognition in the areas of drug research and development, approval, and expansion of indications. In addition, it has become an important development direction of evidence-based medicine to discover authentic and high-quality RWE. In this review, recent articles on real world research/study (RWS) of colorectal cancer at home and abroad were introduced. Moreover, the results of the meta-analysis of RWS and its corresponding randomized controlled trials (RCT) were compared and evaluated to elaborate on the characteristics, research methods, and advantages of RWS compared with traditional studies, and the condition of RWS application in the field of colorectal cancer was summarized. On this basis, the value and prospects of RWS in clinical research on colorectal cancer were summarized, providing new ideas for researchers in the future.
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