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Significant Progress in China's Boao Lecheng Real-World Clinical Data Application Pilot Project

Main image to the post Significant Progress in China's Boao Lecheng Real-World Clinical Data Application Pilot Project

Since its inception in June 2019, the Boao Lecheng real-world clinical data application pilot project has achieved remarkable milestones, including research on 40 different drugs and medical devices. According to Wang Gang, the deputy director of the Hainan Medical Products Administration, a significant outcome of this project has been the market approval of 17 products, which were backed by real-world evidence during their clinical evaluations.

At the third Boao International Conference on Real World Studies of Medical Products, Wang emphasized the importance of this initiative for attracting regulatory agencies from advanced pharmaceutical nations, such as the United States and Japan, to witness China’s innovative strides in real-world data applications. Jia Ning, the director of Hainan's Boao Lecheng International Medical Tourism Pilot Zone, indicated that the conference aims to strengthen international partnerships and display Lecheng's achievements—the only extensive testing ground in China for real-world data application in medicine.

The conference is also focused on engaging more global pharmaceutical and medical device companies, as well as leading experts and scholars, in clinical real-world studies in Lecheng. Collaborations were further highlighted by Anne-Marie Duguet, a professor at the University of Toulouse-III, who mentioned potential joint efforts between China and France in the storage and provision of clinical data, particularly for rare diseases, allowing such data to be utilized for further research.

Moreover, Duguet advocated for exchange programs whereby young researchers from both countries could visit each other, enhancing their understanding of real-world study organization and promoting a collaborative spirit. Meanwhile, He Weigang, deputy director of the National Medical Products Administration’s medical device evaluation center, pointed out the complexities involved in collecting real-world data, which requires collaboration among various stakeholders. He acknowledged the numerous challenges related to technicalities and methodologies in data collection, quality assessment, and processing that need careful attention.

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May 21, 2023 | 05:09