On October 16, the “Academic Annual Conference of NMPA Key Laboratory for Real-World Data Research and Evaluation in Hainan and Regulatory Science Summit on Clinical Research, Evaluation and Commercialization” was formally opened.

At the site, the real-world study consortia for infectious diseases, hepatobiliary & pancreatic diseases, medical examination, eye diseases, respiratory system diseases and tumors were established, which were respectively initiated by academicians of Chinese Academy of Engineering Li Lanjuan, Zheng Shusen and Shang Hong, president Qu Jia of Eye Hospital of Wenzhou Medical University, president Li Weimin of West China Hospital of Sichuan University, Cai Jianqiang, deputy director of the National Cancer Center and vice president of Tumor Hospital of Chinese Academy of Medical Sciences.

At the establishment ceremony, the initiator and representative of each consortium delivered a brief speech to introduce the member organizations, development direction and construction goals of the consortium, expecting to participate in the sincere cooperation between member organizations, advance with experts and scholars, and promote the establishment of an ecosystem for scientific and real-world studies in related disciplines and fields, and ultimately fully promote the generation and commercialization of high-quality real-world data in various fields.

The Real-world Study Consortium for Infectious Diseases

Li Lanjuan, an academician of Chinese Academy of Engineering: Infectious diseases are a threat to the health of humankind, social stability and national security. Therefore, effective diagnosis and treatment of infectious diseases are very important to the protection of the people’s health. This time, we have established a real-world study consortium for infectious diseases with Chinese medical experts on infection. After the consortium is established, we will introduce and pilot new drugs and medical devices that have been marketed abroad in Boao Lecheng.

For example, we will introduce the new anti-fungus drug AmBisome from abroad and apply it in the treatment of patients with invasive fungal infection, which will be piloted in Lecheng Pilot Zone first before being promoted nationwide. Thanks to all our peers traveling here over a long distance from different regions of China. I am convinced that with the concerted efforts of all experts, we will surely develop the real-world study consortium for infectious diseases well.

The Real-world Study Consortium for Hepatobiliary & Pancreatic Diseases

Zheng Shusen, an academician of Chinese Academy of Engineering: China is a country with a high incidence rate of hepatobiliary and pancreatic tumors, which are difficult to be diagnosed in the early stage, high in degree of malignancy, lacking effective treatment means and seriously harming the people’s health. After the real-world study consortium for hepatobiliary & pancreatic diseases is established, it will carry out real-world studies on new drugs and medical devices at the practical base of Boao Lecheng, with an aim to promote the piloting of related innovative medical products in the field of hepatobiliary and pancreatic diseases and allow the domestic patients to use international innovative drugs sooner.

For the establishment of the consortium, we’ve worked with a large number of nationally renowned hepatobiliary and pancreatic hospitals and liver transplantation centers. It will integrate quality resources of the nation in this field, speed up the research and promotion of new technologies, promote the real-world studies in multiple centers efficiently and boost the development of China’s cause of hepatobiliary and pancreatic diseases and liver transplantation.

The Real-world Study Consortium for Medical Examination

Han Xiaoxu, deputy director of National Clinical Research Center for Medial Examination (entrusted by Shang Hong, an academician of Chinese Academy of Engineering to deliver a speech): Medical examination boasts distinctive characteristics compared with other clinical practices, which influences the quality and efficiency of disease diagnosis and treatment. According to statistics, compared with developed countries, China still lags behind 3-5 years in terms of clinical examination.

Through the consortium, we hope to introduce some new examination technologies and products that have been approved abroad, yet still not marketed in China, including management of chronic diseases to pilot and try new technologies and indicators related with tumors, infectious diseases and immunity diseases, thereby obtaining real-world data, providing related data support for the aforesaid products to benefit Chinese people better and sooner, and providing evidences for their approval in the domestic market.

The Real-world Study Consortium for Eye Diseases

Qu Jia, president of the Eye Hospital of Wenzhou Medical University (WMU): The eye diseases cover our entire life cycle. With the social and economic development, people have paid more and more attention to the health of eyes. The Eye Hospital of WMU owns a National Key Laboratory, a National Engineering and Medical Research Center, a National Clinical Research Center, a Key Laboratory for Research and Evaluation of Drugs and Medical Devices for Eye Diseases under NMPA, and 16 bases at provincial and ministry levels. On this basis, we are the earliest to respond to the national policy and establish an Eye Center at Boao Lecheng, and carry out a series of fruitful work.
After the establishment of the real-world study consortium for eye diseases, we will recruit patients in need to Lecheng for a real-world study to generate more and preciser data, turn data into real-world evidences, and make our due contribution to the leading position of China’s real-world studies in the world.

The Real-world Study Consortium for Respiratory System Diseases

Wang Gang, professor with the Department of Respiratory Medicine, West China University of Sichuan University (entrusted by Li Weimin, president of West China University of Sichuan University to deliver a speech): The respiratory medicine is closely related with the people’s lives. The respiratory medicine of West China Hospital is a key discipline of the Ministry of Education and a direction supported by the hospital in priority. Under the leadership of President Li Weimin, the discipline has established a medical big data team of multiple disciplines such as respiratory imaging, extrathoracic computer science and technology, and a remote platform for group and transfer consultation of respiratory problems and critical diseases, and formed a prevention and treatment system for respiratory diseases composed of hospitals at various levels.
Based on the NMPA Key Laboratory for Real-World Data Research and Evaluation in Hainan, the consortium will work with the core member organizations and network organizations to further establish a national multi-center respiratory system disease linked data platform. Through long-term regular follow-up visits, we will develop a real-world database for respiratory system diseases, lay the foundation for the observation of development law and the research of pathological mechanisms of respiratory diseases, and work hard for the building of Healthy China.

The Real-world Study Consortium for Tumors

Cai Jianqiang, deputy director of National Cancer Center and vice president of Tumor Hospital of Chinese Academy of Medical Sciences: We have been engaged in the real-world studies of tumors with other countries for many years. The holding of the forum this time will not only enhance our understanding of real-world studies, but also exhibit our practical achievements in real-world studies and further promote the development of real-world studies in China.
The six consortia established this time will surely play a bigger role under the support of real-world data. I also hope to make my own contribution to these real-world study consortia and expect that under our joint efforts, we will do a good job in the real-world studies and make a bigger contribution to the medical and health services of China.