On August 18, the appraisal results of applications with National Natural Science Foundation of China were announced. The team of NMPA Key Laboratory for Real-World Data Research and Evaluation in Hainan (hereinafter referred to as the Key Laboratory) won approval for three projects.

The three projects approved this time are all based on the disease-specific real-world data system of Lecheng built painstakingly by the Key Laboratory, which will play a key boosting role for the clinical optimization and use of licensed medical products and trial application of real-world data at Lecheng Pilot Zone, and further firm Hainan’s confidence and determination to scramble for the “world’s No. 1” position in the application of real-world data.

It’s reported that the Key Laboratory will be co-built, managed and shared by West China Hospital of Sichuan University, Boao Super Hospital, and Adverse Drug Reaction Monitoring Center of Boao Lecheng Pilot Zone, based on the national strategy of the construction of Hainan Free Trade Port and led by the innovation of national medical products regulatory system and mechanism. It will integrate the comprehensive clinical advantages and scientific research strength of West China Hospital of Sichuan University and the policy and platform advantages of Lecheng Pilot Zone, and build a real-world data platform of “Lecheng, Hainan and China” round the approval and post-marketing regulation of innovative drugs and medical devices.

Under the great support of National Medical Products Administration, Hainan Medical Products Administration, Lecheng Administration and West China Hospital of Sichuan University, the Key Laboratory began to be deeply involved in the trial application of real-world data in Lecheng from early 2019 and has performed a series of work around the theoretical method researches and application practice innovation of real-world data. It has been one of the early organizations to establish systematic theoretical methods for real-world study in China, and built a disease-specific real-world data system at Lecheng. Around the clinical approval and regulation of innovative medical products, it has carried out a series of regulatory science researches with related departments of National Medical Products Administration in secret to support the establishment of technical guidance principles and norms. Around the rational clinical use of innovative medical products, it has established a research system based on real-world big data and artificial intelligence.

As one of the earliest teams involved in the trial application of real-world data, the Key Laboratory has supported six real-world study programs of the first and second batches of licensed medical products at Lecheng, and achieved a major breakthrough in the marketing approval for the first medical device (Allergen XEN glaucoma treatment system) wit domestic real-world data in China and the declaration of the first new drug (OcuMension FAI implant) completely based on the real-world data of Lecheng. Meanwhile, it has provided overall guidance and design of real-world study plans for ten products to be declared among the third batch of pilot drugs and medical devices.

The projects approved this time are further extension on the basis of established key laboratory platform and existing researches, which will play a key boosting role for the clinical optimization and use of licensed medical products and trial application of real-world data at Lecheng. The research achievements, technically speaking, belong to the frontier fields of real-world studies, which will solidify the foundation and practical experience of China in real-world studies, promote the licensed medical practice in Lecheng with scientific and effective methods, constantly promote and deepen the trial application of real-world data of licensed medical products, accelerate the clinical research and development of licensed innovative medical products to benefit the patients in China.

In the next step, the Key Laboratory will work with renowned real-world data experts at home on the basis of the projects approved by the National Natural Science Foundation of China. It will carry out practical researches on the carrier of licensed innovative medical products in Lecheng around the goals of real-world data such as promoting the R&D of innovative medical products, accelerating their marketing and strengthening their regulation, and establish a complete discipline system for the scientific research, application and commercialization of real-world data to further build Boao Lecheng into an academic highland of real-world studies in China.