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 address the issues encountered in real-world studies at Lecheng such as the ethical compliance, completeness and reliability of data collection and scientificity of research design, on February 23, Hainan Institute of Real World Data organized and held the second seminar on real-world study of 2022.

The meeting place in Beijing

The meeting place of the Lecheng Administration

The meeting place of HMPA

The seminar was chaired by Yao Chen, the vice president of Hainan Institute of Real World Data, director of Medical Statistics Office of Peking University First Hospital and vice president of Peking University Clinical Research Institute. With an aim to address actual problems, the meeting was attended by management and practitioners from competent departments and research institutes of industries such as healthcare, medical product regulation, science and technology, medical institutions, medical product manufacturers, CRO companies and big data companies.

At the meeting, the experts and scholars from related fields such as clinical medicine, pharmacology, ethics, law, methodology and statistics discussed on the topic of how to carry out real-world studies that meet regulatory requirements. Based on their rich professional knowledge and practical experience and the actual conditions and characteristics of the pilot program of real-world data application in Lecheng, the attendees fully discussed three issues, namely ethical compliance, research design and how to obtain relevant and reliable real-world data under the precondition of guaranteeing the patients’ rights and benefits and data security. They put forward many constructive ideas and suggestions to promote the real-world studies in a compliant and efficient manner.

In order to motivate relevant research institutes and experts in China to be actively involved and further promote the medical product real-world data standard, collection, analysis and application research, funded by the Lecheng Administration, the Hainan Institute of Real World Data launched the real-world study funding program of 2022, which will be mainly used to fund the researches such as real-world evidence and data in such aspects as methodology, laws and regulations, standards, mechanisms and ethics.

The event was attended online and offline by Liu Guisheng, the director of the Planning and Appraisal Office of the Department of Scientific Education under the National Health Commission, You Mao, a research fellow with the Health Development Research Center of National Health Commission, Hua Yutao, director of China National Center for Biotechnology Development, Yan Zhi, a Party committee member and deputy director of the Lecheng Administration, Fu Zhu, a Party committee member and deputy director of Lecheng Administration, Wei Maoguo, director, Li Lijing, executive deputy director of Lecheng Medical Products Administration, Qu Jia, executive president of Hainan Institute of Real World Data, and experts from the Food and Drug Inspection Center of NMPA, HMPA, institutes of higher learning, research institutes, medical institutions, pharmaceutical companies and CRO companies.