JZUS - Journal of Zhejiang University SCIENCE

Journal of Zhejiang University SCIENCE B

Accepted manuscript available online (unedited version)

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

Author(s): Jingxin JIANG, Weiwei PAN, Liyang SUN, Liwei PANG, Hailang CHEN, Jian HUANG, Wuzhen CHEN
Affiliation(s): Department of Breast Surgery (Surgical Oncology), Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310009, China; more
Corresponding email(s): hjys@zju.edu.cn, chenwuzhen@zju.edu.cn
Key Words: Real-world study (RWS); Precision oncology; Real-world data (RWD); Study design; Data characterization

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Jingxin JIANG, Weiwei PAN, Liyang SUN, Liwei PANG, Hailang CHEN, Jian HUANG, Wuzhen CHEN. Real-world data and evidence: pioneering frontiers in precision oncology[J]. Journal of Zhejiang University Science B,in press.Frontiers of Information Technology & Electronic Engineering,in press.https://doi.org/10.1631/jzus.B2400285

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author="Jingxin JIANG, Weiwei PAN, Liyang SUN, Liwei PANG, Hailang CHEN, Jian HUANG, Wuzhen CHEN",
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year="in press",
publisher="Zhejiang University Press & Springer",
doi="https://doi.org/10.1631/jzus.B2400285"
}

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Abstract
Chinese Summary
Academic Network
Reviewer Comment

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. 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.

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