China's real-world medical data pilot project makes major progress

Since its launch in June 2019, the Boao Lecheng real-world clinical data application pilot project has made significant progress, with 40 drugs and medical devices included in the research, according to Wang Gang, deputy director of the Hainan Medical Products Administration.

Speaking during an interview at the third Boao International Conference on Real World Studies of Medical Products on Saturday, Wang noted that 17 of these products have received market approval, supported by real-world evidence for their clinical evaluations.

The annual conference has attracted participation from drug and device regulatory agencies from countries such as the United States and Japan, which allows developed nations in the pharmaceutical sector to witness China's advancements in this cutting-edge field of soft science, where it is now keeping pace globally and even leading in some areas, said Jia Ning, director of Hainan's Boao Lecheng International Medical Tourism Pilot Zone.

The conference aims to further enhance international collaboration in real-world study, showcasing the significant achievements of Lecheng, China's inaugural and sole testing ground where real-world data finds extensive application. It also seeks to attract more global pharmaceutical and medical device companies, along with top experts and scholars, to engage in clinical real-world data study in Lecheng, said Jia.

Anne-Marie Duguet, professor at the University of Toulouse-III in France, highlighted the potential for China and France to collaborate on comparison for storing and providing clinical real-world data for research. She noted that data initially collected for the treatment of rare diseases could be safely stored and subsequently used for secondary research purposes.

Additionally, Duguet said that young researchers in China and France can visit each other to learn about how real-world study is organized, fostering international collaboration and knowledge exchange.

He Weigang, deputy director of the center for medical device evaluation of National Medical Products Administration, emphasized that collecting real-world data requires multi-party collaboration, which is easier said than done. He noted that there are numerous technical and methodological challenges in data collection, quality assessment, and processing that need to be addressed.