Presentation (CTI)

OBJECTIVES: Asia-Pacific generates approximately 50% of global oncology real-world evidence (RWE) publications, yet no assessment exists of methodological quality, infrastructure maturity, or regulatory utility specifically for targeted therapies in the region. This targeted review aimed to characterise the volume, quality, data infrastructure, and regulatory acceptance of oncology RWE across seven Asia-Pacific markets.
METHODS: A targeted review was conducted across PubMed, Embase, regulatory databases, and ISPOR repositories (2018-2026). Included were RWE studies evaluating targeted oncology therapies, regulatory guidance documents on RWE acceptance, and data infrastructure analyses from Japan, South Korea, China, Taiwan, Australia, India, and Thailand. Data were extracted on study design, quality indicators, journal impact, multi-country collaboration, and regulatory impact.
RESULTS: Fifty-eight publications and 19 regulatory guidance documents were identified. RWE output grew 53% from 328 to 502 studies annually (2020-2022). China contributed 275 studies, followed by Japan with over 100. However, 85% were retrospective, 41% single-centre, and only 8% multi-country. Median journal impact factor was 4.4, with 3% in journals above impact factor 7. Infrastructure varied widely: Taiwan's National Health Insurance Research Database covers 99% of the population with 98.4% cancer registry completeness; South Korea's K-CURE integrates nationwide cancer-claims data; Japan's MID-NET encompasses 32 million records; India's registries cover only 11%. China published six RWE guidance documents (2019-2023), enabling 13 product approvals via the Boao pilot zone. Japan accepted registry data as external controls for landmark oncology approvals. Biomarker-clinical outcome data linkage remains absent outside specialised registries. The ESMO GROW reporting standards have not been assessed for Asia-Pacific uptake.
CONCLUSIONS: Despite leading global RWE volume, Asia-Pacific targeted oncology studies are predominantly retrospective, single-centre, and published in lower-impact journals. Infrastructure disparities, absent biomarker-outcome linkage, and limited cross-border harmonisation undermine regulatory and reimbursement utility. Standardised quality frameworks and investment in federated data models are needed to improve precision oncology access and outcomes across the region.