The challenges and opportunities in using real-world data to drive advances in healthcare in East Asia: expert panel recommendations
- Recommend approaches to improve the use of Real-World Evidence (RWE) in healthcare decision-making in East Asia and beyond.
- Encourage large-scale collaborations involving diverse stakeholders.
- Key stakeholders include government agencies, hospitals, research organizations, patient groups, and the pharmaceutical industry.
- Focus on ensuring access to robust and reliable real-world data.
- Seek alignment on addressing prioritized evidence needs.
- Multidisciplinary teams with expertise in healthcare research, data science, and IT will be crucial.
- Aim to foster further discussion to shape the RWE landscape and drive next-generation healthcare.
Real-world data (RWD) relating to patient health status and/or the delivery of healthcare can be broadly defined as data that are collected outside of conventional clinical trials. These data are derived from a variety of sources, including electronic medical records (EMRs), insurance claims and billing systems, treatment and disease registries, and information directly contributed by physicians and patients.
High-quality real-world evidence (RWE) relies on appropriate analysis of RWD collected in ways that maximize completeness, accuracy, standardization, and timeliness, and reduce bias. Such RWE has long been used in postmarketing research and regulatory monitoring, including in long-term safety assessments, and to inform clinical decision-making. There is a need for flexible regulatory mechanisms to support decision-making, and RWE is increasingly used to inform regulatory decisions, health technology assessments (HTAs), and reimbursement decisions...
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