On January 17, 2022, the training class on the operating system of clinical trials co-held by Hainan Institute of Real World Data and Lecheng Clinical Research Center was opened at Lecheng Pilot Zone. Fu Zhu, a Party committee member and deputy director of Lecheng Administration and vice president of Hainan Institute of Real World Data, presided over the opening ceremony and delivered a speech.

The training was intended to promote the construction of clinical trial institutions for drugs, strengthen the clinical researchers’ mastery of knowledge such as GCP, guarantee the high quality of clinical research of drugs and facilitate the integrated construction of clinical research of medical institutions in Lecheng. Meanwhile, it aimed to strengthen the construction of Lecheng’s ethical review capacity, enhance the ethical review efficiency of clinical research and better protect the rights and benefits of the patients, and promote the real-world studies at a faster pace.

The training was solid in faculty. The main lecturers included professor Yao Chen, vice president of Peking University First Hospital and Hainan Institute of Real World Data, professor Cong Yali, director of the medical ethics and law department of the school of medical humanities, Peking University, Chen Jian, director of the institutional office director of Zhejiang Xiaoshan Hospital and other renowned experts and scholars, as well as corporate executives and managers such as Dr. Wu Anfan, the executive director with the Biomedical Research Center of Beijing Novartis Pharm Co., Ltd., Dr. Tian Haijun, executive director in charge of real-world evidence with Beijing Novartis Pharm, and Hou Chunfang, the person-in-charge of the Shanxi and Shandong regions of Tiger Group’s E-SITE Center of Excellence.

The training was rich in contents, such as reflection on the construction of the regional ethics committee, new drug research and development and organization and functions of clinical trial institutions, the research and development of innovative drugs and medical decision-making assisted by real-world evidence, real-world data collection, ethical consideration in the course of administration and management, organization and launch of Phase I and BE clinical trials, and quality management in clinical trials.

The training was held online and offline, which was attended by over 100 people from posts such as clinical research, GCP declaration and ethical review of medical institutions, pharmaceutical enterprises, medical product developers and CRO companies.