In order to implement the strategic deployment of the State Drug Administration and the Hainan Provincial Party Committee and Provincial Government, and to better serve the enterprises that are conducting or will conduct real-world research on licensed drugs in Lecheng, on February 28, it was sponsored by the Hainan Real World Data Research Institute. The pharmaceutical real-world data research training and symposium was held in the Boao Lecheng Pioneer Zone.

The training was given by Prof. Chen Pingyan, former director of the Department of Biostatistics of Southern Medical University and Executive Dean of Hainan Real World Research Institute, and Wu Ying, associate professor of the Department of Biostatistics of Southern Medical University. Li Yunda, Deputy Director of the Hainan Provincial Drug Administration, Fu Zhu, Deputy Director of the Lecheng Pioneer District Administration and Vice President of the Hainan Real World Data Research Institute, Wang Gang, Director of the Drug Registration and Production Division of the Hainan Provincial Drug Administration, Hainan Provincial Drug Administration Expert leaders such as Wei Chunmin, deputy director of the Medical Device Review Service Center, and more than 70 representatives of medical drug and data companies and medical institutions from all over the country attended the meeting.

At the meeting, Deputy Director Fu Zhu first introduced the establishment background, organizational structure, research tasks and operation mechanism of the Drug and Medical Device Regulatory Scientific Research Base of the State Food and Drug Administration and the Hainan Real World Data Research Institute. Director Wang Gang introduced the progress of the Lecheng real-world data pilot work, and expressed his hope that in the future, companies registered and listed in China with the help of Lecheng’s real-world research will give priority to customs declaration in Hainan. You can also keep the fruit in Lecheng.”
In the morning training session, Prof. Chen Pingyan explained the "Guidelines for Real-World Evidence Supporting Drug Development and Review (Trial)" and "Guidelines for Real-World Data for Generating Real-World Evidence", and explained the background of conducting real-world research. , the scope of use of real-world evidence for regulatory decision-making, and the issues that need to be paid attention to in communication with review agencies. The core of conducting real-world research is how to obtain real-world evidence from real-world data. In this regard, Associate Professor Wu Ying gave a professional interpretation of the principles and methods of causal inference in real-world research.

Regarding the actual patient recruitment problems faced by pharmaceutical companies in developing RWS in Lecheng, Zhang Tianze, founder of Zero Krypton Technology, proposed solutions such as using big data recruitment and channel cooperation based on the "data platform" at the meeting.

Expert leaders from the Hainan Provincial Food and Drug Administration and the Hainan Provincial Real World Data Research Institute gave detailed answers to the relevant questions encountered by pharmaceutical companies in conducting clinical real-world research, including the selection criteria for pilot varieties, sample size, patient follow-up, Rare disease RWS policy and children's medication, etc. Representatives of participating companies actively asked questions and responded enthusiastically. They all said that today's training was full of dry goods, which greatly increased their confidence in conducting real-world research more scientifically and efficiently in Lecheng.

In his concluding remarks, Deputy Director Li Yunda said that carrying out real-world data research can shorten the time to market of drugs, save the cost of enterprises, and allow good drugs to enter the Chinese market faster to benefit domestic patients. To this end, the National Center for Drug Evaluation, the Provincial Food and Drug Administration and the Lecheng Administration have established a working mechanism, and have communicated and discussed the establishment of the application route, the list of application materials and requirements. Today's meeting is to promote this work. concrete measures to be implemented.

Finally, Deputy Director Fu Zhu fully affirmed the prospect of Lecheng real-world data research. He hoped that participating enterprises and medical institutions will actively cooperate to jointly promote real-world research projects to blossom and bear fruit in Lecheng as soon as possible, so that Lecheng's policy dividends will benefit the whole country. people.