Abstract
Various real-world data (RWD) sources have emerged in China with the intention of generating real-world evidence (RWE) that can be used in clinical and regulatory decision-making. Despite these efforts, significant barriers remain that hinder high-quality healthcare research. A workshop with 30 representatives from healthcare research agencies, technology companies focused on healthcare big data and pharmaceutical companies was held in December 2020 to identify strategies to overcome the barriers associated with the usability and quality of RWD in China. Across all sectors, examples of barriers identified included inconsistencies in terminology and non-standardised coding practices; the absence of longitudinal data; the absence of transparent data processing and validation practices; and the inability to access and share RWD. While cutting-edge technological innovations and data solutions provided powerful tools, the development of collaborative and synergistic research networks across multiple stakeholders is key to generate accessible, high-quality RWD in China. RWD has the potential to provide clinical, regulatory and reimbursement decision-makers with critical insights that can improve healthcare delivery in China. However, barriers to its access, collection and use must be addressed to generate RWE to guide healthcare stakeholders.