Real world data (RWD) is information collected from a variety of sources alongside routine clinical practice. It supports the assessment of how a health care intervention performs in ‘real-life’ settings as opposed to a research environment. It also helps us to assess the risk-benefit or cost-benefit of a health care product throughout a product’s lifecycle, rather than as a one-off exercise when the product is launched. Sources of data that can support this include electronic health records, claims databases, and clinical registries.
Regulators and health technology assessment (HTA) bodies are increasingly requiring RWD to inform decision-making. In 2015, OHE produced a report, commissioned by Lilly, which assessed the core governance arrangements for how RWD is accessed or generated, and used credibly to provide evidence in eight countries. The authors proposed an aspirational governance framework that could guide the management of data access and use.
In a new follow-up report, also commissioned by Lilly, we consider the opportunities for data collection and use in South Korea. The report was co-authored by collaborators Professor Eui-Kyung Lee and Jae-A Park from SungKyunKwan University, and highlights the advanced capacity for data collection in South Korea, which operates a single-payer health insurance system. Patients’ utilisation of healthcare resources are captured readily through claims databases, operated by the National Health Insurance Service (NHIS) and the Health Insurance Review and Assessment Service (HIRA). Processes for data access and use are clear and maintain strong requirements for data protection. However, access tends to be limited to state, local government and public institutions, or research organisations with an academic or public policy purpose. Opportunities for data linkage are limited, and the patient consent models that guide data use are unclear at present.
South Korea’s health system infrastructure has developed rapidly over the past 30 years, and the priority now should be on efforts to improve quality of care. The collection and use of RWD is key, and an appropriate governance framework can support the translation of data into evidence and insight, thereby supporting improvements in health care.
Posted in Drug Development/R&D, Health Care Systems, OHE Consulting, Use of Medicines | Tagged Consulting Reports