NMPA Research Base for Drug and Medical Device Regulatory Science Hainan Institute of Real World Data
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Experts of Peking University Lecture on Real-world Study in the 2nd Training Session of CER at Leche

2022-03-14 301

In order to promote the construction of drug clinical trial institutions, strengthen the drug clinical researchers’ mastery of clinical research knowledge, and facilitate the integrated construction of clinical research of medical institutions in Lecheng, on March 12, the second training session of Observational Comparative Effectiveness Research (CER) was held successfully at Lecheng Pilot Zone of Boao.

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In the last session, Zhan Siyan, the dean, research fellow Gao Pei, associate professor Sun Feng from the school of public health of Peking University, professors Zhai Suodi and Chen Yahong from Peking University Third Hospital, and Yao Chen, vice president of Hainan Institute of Real World Data explained related contents such as setting of the training class, development of CER and design thinking, which has received wide praise from the attendees.

In the second training session, several young scholars from Peking University interpreted CER in depth from the perspective of its application in scientific research, and shared the applications of CER in fields such as chronic illness, TCM, tumor and vaccine with actual cases.

Associate professor Tang Xun analyzed the identification and control methods of confounding factors in clinical research from the perspective of actual analysis. Associate research fellow Zeng Lin analyzed the relevant issues in CER such as heterogeneity and subgroup analysis. Teacher Zhao Houyu delivered a professional analysis of the application of propensity score and tool variables in the CER.

Associate research fellow Yan Xiaoyan analyzed the research design progress and case of effective RCT. Associate research fellow Li Nan combined theory and practice in analyzing how to handle missed data in clinical research. Teacher Zhang Haihong analyzed the ethical consideration of CER based on many years of ethics experience. Associate research fellows Xu Yang, Tao Liyuan and Wang Shengfeng and teacher Liu Zhike analyzed the application of CER in such areas as chronic illness, TCM, tumor and vaccine based on actual cases.

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The training class was hosted by Hainan Institute of Real World Data and attended online and offline by over 100 staff engaged in clinical research, statistics, institutional office affairs, medical affairs, registration and data management with medical product regulators and reviewers, medical product manufacturers, medical institutions and research institutes.