Real-World Data in Health Technology Assessment: Do We Know It Well Enough?

Abstract

AbstractAdvanced data science leads the fourth revolution. Data are not only contributing to developing new technologies, but also are expected to help provide scientific and systematic evidence to policymakers by combining all available evidence. In health care, big data and real-world data (RWD) are major key concepts. While they share the similarity, two data are different. As the interests in data being increased, the health technology assessment (HTA) agency faces another phase to incorporate these data in appraising new health technology. This chapter focuses on RWD to discuss the opportunities and challenges of using RWD in HTA. RWD is expected to help supplement the information of survival model, comparators, generalisability and rare cancers along with RCTs. However, there are some limitations to use RWD in HTA, such as no consensus on the definition of RWD, the risk of confounder, challenges to assess the relative treatment effects, quality of data and also generalisability issue. In order to use RWD appropriately in HTA, the deliberation based on the understanding of limitation should be accompanied.