Analysis Group, Inc, Beijing, China
MSD R&D (China) Co., Ltd, Beijing, China.
BMJ Open. 2022 Jul 29;12(7):e063139. doi: 10.1136/bmjopen-2022-063139.
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.
各种真实世界数据（RWD）来源在中国涌现，旨在生成可用于临床和监管决策的真实世界证据（RWE）。尽管做出了这些努力，但仍存在重大障碍，阻碍了高质量的医疗保健研究。2020 年 12 月，举办了一次有 30 名来自医疗保健研究机构、专注于医疗保健大数据的技术公司和制药公司的代表参加的研讨会，以确定克服与中国 RWD 的可用性和质量相关的障碍的策略。在所有部门中，确定的障碍示例包括术语不一致和非标准化编码实践；缺乏纵向数据；缺乏透明的数据处理和验证实践；以及无法访问和共享 RWD。虽然先进的技术创新和数据解决方案提供了强大的工具，但跨多个利益相关者开发协作和协同研究网络是在中国生成可访问、高质量 RWD 的关键。RWD 有可能为临床、监管和报销决策者提供关键见解，从而改善中国的医疗保健服务。然而，必须解决其获取、收集和使用的障碍，以生成 RWE 来指导医疗保健利益相关者。
