Real-world data and evidence: pioneering frontiers in precision oncology

Jingxin JIANG; Weiwei PAN; Liyang SUN; Liwei PANG; Hailang CHEN; Jian HUANG; Wuzhen CHEN

doi:10.1631/jzus.B2400285

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Review | Updated：2026-01-27

Real-world data and evidence: pioneering frontiers in precision oncology
Real-world data and evidence: pioneering frontiers in precision oncology
真实世界数据与证据：精准肿瘤学的革新领域
Journal of Zhejiang University-SCIENCE B Vol. 27, Issue 1, Pages: 44-57(2026)
Affiliations：

1.Department of Breast Surgery (Surgical Oncology), The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310009, China
2.Key Laboratory of Tumor Microenvironment and Immune Therapy of Zhejiang Province, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310009, China
3.Cancer Institute, Zhejiang University, Hangzhou 310009, China
4.Department of Neurosurgery, Lanxi People’s Hospital, Jinhua 413045, China
5.Department of Oncology, Lanxi People’s Hospital, Jinhua 413045, China
Funds：
DOI：10.1631/jzus.B2400285
CLC：
CSTR：
Received：03 June 2024，

Revised：2024-11-11，

Published Online：22 December 2025，

Published：27 January 2026
Accepted：

姜晶鑫,潘唯玮,孙里杨等.真实世界数据与证据：精准肿瘤学的革新领域[J].浙江大学学报（英文版）（B辑：生物医学和生物技术）,2026,27(01):44-57.

Jingxin JIANG, Weiwei PAN, Liyang SUN, et al. Real-world data and evidence: pioneering frontiers in precision oncology[J]. Journal of Zhejiang University-SCIENCE B, 2026, 27(1): 44-57.
姜晶鑫,潘唯玮,孙里杨等.真实世界数据与证据：精准肿瘤学的革新领域[J].浙江大学学报（英文版）（B辑：生物医学和生物技术）,2026,27(01):44-57. DOI： 10.1631/jzus.B2400285.

Jingxin JIANG, Weiwei PAN, Liyang SUN, et al. Real-world data and evidence: pioneering frontiers in precision oncology[J]. Journal of Zhejiang University-SCIENCE B, 2026, 27(1): 44-57. DOI： 10.1631/jzus.B2400285.

摘要

真实世界研究（RWS）已成为肿瘤学研究领域中的一股革新力量，它通过提供在常规临床环境中实施肿瘤治疗的综合视角，有效补充了传统随机对照试验（RCT）的局限。本综述探讨了RWS在肿瘤领域中的发展现状，重点关注其具体实践、方法学考量以及对精准医疗的推动作用。本文系统分析了RWS如何整合电子健康记录（EHR）、保险索赔和患者登记等多源数据，生成真实世界证据，从而搭建起连接临床试验与真实世界临床实践的桥梁。本综述强调了RWS在精准肿瘤治疗中的贡献，包括评估在传统研究中被低估人群中的治疗结果、拓展药物适应症，以及在真实临床环境中肿瘤治疗的长期安全性和有效性。此外，我们还讨论了人工智能等新兴技术在应对数据质量变异和隐私问题等重大挑战中的应用潜力。总之，RWS与传统临床研究的整合正在革新精准肿瘤的研究范式，使基于真实世界证据的个性化治疗策略成为可能。

Abstract

Real-world studies (RWSs) have emerged as a transformative force in oncology research

complementing traditional randomized controlled trials (RCTs) by providing comprehensive insights into cancer care within routine clinical settings. This review examines the evolving landscape of RWSs in oncology

focusing on their implementation

methodological considerations

and impact on precision medicine. We systematically analyze how RWSs leverage diverse data sources

including electronic health records (EHRs)

insurance claims

and patient registries

to generate evidence that bridges the gap between controlled clinical trials and real-world clinical practice. The review underscores the key contributions of RWSs

including capturing therapeutic outcomes in traditionally underrepresented populations

expanding drug indications

and evaluating long-term safety and effectiveness in routine clinical settings. While acknowledging significant challenges

including data quality variability and privacy concerns

we discuss how emerging technologies like artificial intelligence are helping to address these limitations. The integration of RWSs with traditional clinical research is revolutionizing the paradigm of precision oncology and enabling more personalized treatment approaches based on real-world evidence.

关键词

Keywords

references

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