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.

Key words: Real-world study (RWS); Precision oncology; Real-world data (RWD); Study design; Data characterization

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