The 5th-anniversary recap and exchange conference of the Lecheng real-world clinical data application pilot project convened on Thursday in Boao, Hainan province, to strengthen the importance of real-world studies in improving how drugs and medical devices are evaluated and to boost the status of these studies. Real-world studies are conducted in real-life settings, such as clinics, hospitals or communities, rather than in a controlled laboratory environment.
Representatives from international pharmaceutical and medical device corporations, alongside representatives from medical institutions, assembled to deliberate on the trajectory and advancements in real-world studies.
According to Jia Ning, director of Hainan's Boao Lecheng International Medical Tourism Pilot Zone, the zone is China's inaugural and sole testing ground where real-world data finds extensive application. Since the inception of the clinical real-world data application pilot project in June 2019, the pilot zone has established in-depth cooperation with more than 170 medical device companies in over 20 countries and regions.
Over the past five years, "36 international innovative medical devices have conducted real-world studies in Lecheng, with 15 products securing domestic registration and market approval through real-world data-assisted clinical evaluations", said Zhang Huawei, deputy secretary-general of the Hainan provincial government.
"As one of the first enterprises selected for the Lecheng pilot project, we obtained market approval for a cochlear implant in China with the help of research outcomes derived from real-world data. This process enabled us to shorten the time for market approval by over a year. Additionally, we utilized real-world data effectively for post-market research and promotion of our products," said Li Xinyu, general manager of Cochlear Greater China.
Rezum, a water vapor energy medical device, obtained regulatory approval in China in a mere four months and one day thanks to Lecheng's real-world studies. This milestone has emerged as an important consideration in the strategic planning of global pharmaceutical and medical device corporations for synchronized market entry, said Peng Lin from Boston Scientific.
In the last five years, the Lecheng pilot zone has experienced an average annual growth of 56 percent in medical tourism visitors, coupled with a 65 percent yearly increase in operating revenue. Data from the pilot zone administration shows that the use of specially licensed medications and devices has surged by more than 200 percent annually.
Jia said that Lecheng will take advantage of the Hainan Free Trade Port's preferential policies and its unique position as the first and currently only special medical zone to draw top-tier medical and pharmaceutical industry expertise and resources from domestic and international arenas.
"Our goal is to position Lecheng as a worldwide focal point for real-world study assets, a platform for sharing achievements, and a hub for fostering collaboration and exchange," the director added.
