From June 17th to 18th, the 2021 3rd China Clinical Research Annual Conference & Real World Research Boao Lecheng Practice Dialogue was held in Suzhou.

The conference focuses on real-world research, focusing on four major themes: clinical research standardization and innovation, rational layout of clinical research to accelerate the launch of new products, scientific layout, building a product evidence tree, and Boao Lecheng practice of real-world data supporting R&D and supervision. Attracted nearly 400 experts and practitioners in the pharmaceutical industry.

On the afternoon of the 18th, the Boao Lecheng International Medical Tourism Pilot Zone Administration and Hainan Real World Data Research Institute were invited by the organizing committee to hold a special seminar on "Boao Lecheng Practice of Real World Data Supporting R&D and Supervision". A number of academic experts and industry leaders started from the top-level design, implementation process and project results, and made academic reports on real-world research policies and Lecheng project practice.

Entrusted by Gu Gang, Secretary of the Party Committee and Director of Boao Lecheng International Medical Tourism Pilot Area Administration, Fu Zhucong, Party Committee Member and Deputy Director of Boao Lecheng International Medical Tourism Pilot Area Administration, and Deputy Director of Hainan Real World Data Research Institute. Starting from three aspects: , platform stage and future outlook, he introduced the relevant preferential policies of Boao Lecheng Pilot Zone and the progress of real-world data research to the guests.

Fu Zhu, Deputy Director of Boao Lecheng International Medical Tourism Pilot Zone Administration and Deputy Director of Hainan Real World Data Research Institute, delivered a speech

The country's unique licensing policy of urgently needed imported medical devices has made the Lecheng Pioneer Zone an important test field for the national drug regulatory authorities to conduct real-world data research and application. Since the launch of the pilot work of clinical real-world data application, Lecheng has made continuous breakthroughs. Allergan's glaucoma drainage tube, Johnson & Johnson's full-vision femtosecond laser eye treatment system, and pratinib are three medicinal products, which have been approved by the State Food and Drug Administration by using the real-world data of Lecheng to assist clinical evaluation.

Deputy Director Fu Zhu said that in the next step, the Hainan Provincial Real World Data Research Institute will further use wisdom and leverage to strengthen the base's scientific research capabilities, promote the clinical application of pilot varieties and real-world research, and promote the construction of the basic functions of the real-world research platform in Hainan Province. The Ph.D. graduate site cultivates high-end talents, makes every effort to hold the first Boao International Conference on Real World Research on Pharmaceutical Devices, and builds the Lecheng Pioneer Zone into a real-world data research platform with an international advanced level.

Then, Yao Chen, Director of the Medical Statistics Office of Peking University First Hospital, Deputy Director of the Hainan Institute of Real World Data, and Sun Xin, Director of the China Evidence-Based Medicine Center of West China Hospital, Sichuan University, and Executive Vice President of the Hainan Institute of Real World Data, respectively. Published reports entitled "Statistical Considerations of Real-World Data Supporting R&D and Supervision", "Real-World Data Supporting Medical Device Clinical Evaluation and the Application of Boao Devices' Real-World Data Research", combining the relevant theories of real-world research with the practice of Lecheng. Combined, it brings a wonderful academic feast to the guests.

Yao Chen, Director of the Medical Statistics Office of Peking University First Hospital and Vice President of Hainan Real World Data Research Institute, made a report

Sun Xin, Director of the China Evidence-Based Medicine Center, West China Hospital, Sichuan University, and Executive Vice President of Hainan Real World Data Research Institute, made an online report

Tigermed representative report

Report by Amgen China Representative

In the subsequent high-end dialogue session, the participants actively asked questions and conducted in-depth exchanges with the speaking experts. In response to the questions raised by everyone about the opportunities for pharmaceutical equipment companies in Lecheng and how to better participate in the real-world research pilot in Lecheng, Deputy Director Fu Zhu and Vice President Yao Chen gave detailed answers one by one.

Deputy Director Fu Zhu communicated with the delegates

The whole seminar was full of dry goods and splendid. The academic reports shared by experts and scholars further improved everyone's understanding and understanding of real-world data research, which aroused enthusiastic responses among the participants.

"Real-world research is an emerging thing, and experts and scholars, scientific research institutions, R&D, clinical, CRO and other institutions that are committed to participating in real-world research across the country and even around the world are welcome to participate, and promote the construction of the National Regulatory Scientific Research (Hainan Lecheng) base, and jointly Make Lecheng a highland for real-world data research in China and even the world." Finally, Deputy Director Fu Zhu extended an invitation to all the guests on behalf of the Lecheng Administration.