Jipan Xie, MD, PhD¹; Eric Q. Wu, PhD²; Shan Wang, MD³; Tao Cheng, MD⁴; Zhou Zhou, MS⁵; Jia Zhong, ScD⁵; Larry Liu, MD, PhD^6,7

¹Analysis Group, Inc., Los Angeles, CA, USA; ²Analysis Group, Inc., Boston, MA, USA; ³Department of Surgery, Research Center for Medical Big Data, Peking University People’s Hospital, Beijing, China; ⁴State Key Laboratory of Experimental Hematology and National Clinical Research Center for Blood Diseases, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Tianjin, China; ⁵Beijing Analysis International Consulting Co., Ltd., Beijing China; ⁶Merck & Co., Inc., Kenilworth, NJ, USA; ⁷Weill Cornell Medical College, New York, NY, USA

Real-world evidence (RWE) has been increasingly used in healthcare decision making worldwide. In China, emerging real-world data sources start to pave the way for epidemiology, clinical, health economics, and outcomes research. However, the quality and applicability of these data sources for health care research have not been thoroughly evaluated. This study evaluated major real-world data sources in China using a 2-phase approach. In phase one, we identified various data sources through a targeted literature review and experts’ input. In phase two, we conducted an in-depth assessment of the strengths and limitations of administrative claims and electronic health record data. We identified some general limitations in these databases in China compared to similar ones in developed countries, such as variations in data quality, unclear data usage and access mechanisms, and lack of longitudinal follow-up data. On the other hand, the large sample size and the potential to collect additional data based on research needs present opportunities to further advance RWE in China. Despite the advancements in real-world data, high-quality RWE that can be used to inform decision making remains limited in China. Continuous efforts are needed to address two fundamental challenges that hinder RWE generation: data access and data quality. Establishing a sustainable long-term multi-sector collaboration mechanism is a critical consideration in the continued development of RWE in China. To read this article, please click here.