In 2019, the national government issued the document "Implementation Plan for Supporting the Construction of the Boao Lecheng International Medical Tourism Pilot Area", which allowed the use of innovative drugs and medical devices in medical institution of Boao Lecheng. These medical products had been designed to meet urgent clinical requirements and had been approved by regulatory authorities overseas. Through the use of these medical products, real-world data were generated in the routine clinical practice, based on which real-world evidence might be produced for regulatory decision-making by using scientific and rigorous methods. In March 2020, the first medical device product using domestic real-world data was approved, suggesting that the real-world data initiative in Boao Lecheng achieved initial success. This work also provided important experience for promoting the practice of medical device regulatory decision-making based on real-world evidence in China. Here, we shared the preliminary experiences from the study on the first approved medical device product and discussed the issues on developing a real-world data research framework in Boao Lecheng in attempt to offer insights for future studies.
Citation： REN Yan, LIANG Yuanbo, LIU Mimi, LIN Youhai, LIN Kai, TAN Jing, WANG Wen, LI Ling, LIU Yanmei, JIA Yulong, YAO Minghong, ZOU Kang, CHEN Wei, QU Jia, SUN Xin. Exploration and practice of real-world data studies on innovative medical products in Boao Lecheng: analysis based on Chinese first case of approved medical device using domestic real-world data. Chinese Journal of Evidence-Based Medicine, 2020, 20(10): 1117-1123. doi: 10.7507/1672-2531.202007133 Copy