In order to deeply implement the guideline of the third meeting of the leading group for the pilot program of medical product real-world data application in 2021 and accelerate the real-world studies at Lecheng, on the afternoon of January 24, 2022, the Lecheng Administration organized and held a user training session of Hainan Real-world Data Platform and a seminar on the operation of the Ethics Committee of Lecheng Pilot Zone.

The training discussions were held online and offline, which involved over 100 participants including related people in charge of scientific research and medical affairs with medical institutions in Lecheng Pilot Zone and related professionals from dozens of pharmaceutical enterprises. The meeting was presided over by Fu Zhu, a Party committee member, deputy director of the Lecheng Administration and vice president of Hainan Institute of Real World Data, who also gave a brief introduction to the related background behind the construction of Hainan Real-world Data Platform and the Ethics Committee of Lecheng.

Hainan Real-world Data Platform is the first regional real-world data platform established and built according to related guidelines of the NMPA for real-world study in China, which has been initially accepted and now entered the stage of trial operation. The training mainly explained the main use and operation methods for different users. Meanwhile, it solicited views on a large scale among related concerned parties such as medical institutions and enterprises on the operating mechanism of the platform, with an aim to allow the medical institutions and related pharmaceutical enterprises in the park to understand the specific functions and related operation procedures of the platform and promote the use of the platform at a faster pace.

Under the great support of the Health Commission of Hainan, the Lecheng Administration took the initiative to establish the Ethics Committee of Lecheng Pilot Zone, which is devoted to providing ethical reviews for the real-world studies in Lecheng, so as to improve the ethical review quality and efficiency of real-world studies. Yao Chen, vice president of Hainan Institute of Real World Data, presided over related discussions on regional ethics, and fully compared notes with the representatives attending the meeting on such aspects as pan-informed consent, informed opt-out mechanism and personal information protection law.

In order to ensure that the real-world data collection of Lecheng meets the ethical requirements, enhance the data collection efficiency and protect the patients’ privacy, related discussions were launched on the referring to related international experience on pan-informed consent and the feasibility for medical institutions in Lecheng to carry out pan-informed consent research. In order to allow the medical institutions to be quick, efficient, legal and compliant in collecting data for related studies in the future, vice president Yao Chen suggested every medical institution to develop related administrative regulations on pan-informed consent, to guarantee and protect the patients’ opt-out right at any time, the right to be informed and the right to have their privacy protected.

The meeting was attended by Yan Zhi, deputy director of the Lecheng Administration, and related professionals from HMPA, Lecheng Administration, Hainan Institute of Real World Data, etc.