On February 18, the training class of CER for 2022 hosted by Hainan Institute of Real World Data was opened at Lecheng Pilot Zone. Fu Zhu, a Party committee member and deputy director of the Lecheng Administration and vice president of Hainan Institute of Real World Data presided over the opening ceremony and delivered a speech.

The team led by professor Zhan Siyan of Peking University, the chief translator and expert of “Developing a Protocol for Observational Comparative Effectiveness Research: A User Guide” was invited to give lectures in a systematic manner. The training was intended to promote the construction of drug clinical trial institutions, strengthen the drug clinical researchers’ mastery of clinical research knowledge, ensure the high quality of drug clinical research and boost the integrated construction of clinical research of medical institutions at Lecheng.

The training was divided into two sessions. The first session was held this time. First, Zhan Siyan, the dean of the school of public health of Peking University, introduced the setting of the training class, development of CER, design thinking and other related contents. At the conclusion of his lecture, professor Zhan summarized the differences and associations between CER and RWE (real-world evidence) in particular and pointed out that CER was first initiated by the AHRQ, which emphasizes that evidence is used to promote the quality and efficiency of medical services. RWE was first initiated by FDA, which emphasizes that evidence is used to promote the review and approval of new drugs. However, the main genre of research design of the two is both cohort study, while their core challenge of methodology is both focused on how to handle the bias and confounding factors of observational research. They share the same aim to promote regulatory decision-making with high-quality clinical research and bring more health and well-being to the patients.

A professor team of experts from Peking University

Next, professor Zhai Suodi from Peking University Third Hospital explained the overview, cases and progress of registration research. Yao Chen, vice president of Hainan Institute of Real World Data, explained related contents such as data collection, governance, safety and ethics of CER and the construction of clinical research data platform. Peng Xiaoxia, a research fellow with Beijing Children’s Hospital, Capital Medical University, explained in detail the definition of exposure and outcomes in the CER research and selection of covariant, using chronic obstructive pulmonary disease as an example. Finally, Gao Pei, a research fellow and associate professor Sun Feng with Peking University respectively delivered a wonderful lecture on the statistical analysis thought and reporting regulation of CER. The training was launched “online and offline”, which was attended by around 100 people, including practitioners engaged in clinical research, statistics, institutional office affairs, medical affairs, registration and data management from medical products regulatory and reviewing institutions, pharmaceutical enterprises, medical institutions, research institutes, colleges and universities, and mid-aged and young backbones and graduate candidates.

The opening ceremony is presided over by Fu Zhu

The training was divided into two parts. The first part was unfolded around topics of CER such as subgroup analysis, calculation of sample size, identification and control of bias and confounding factors, and the application of propensity score and tool variables. The second part delivered a detailed analysis with actual cases in such fields as chronic illness, TCM, tumor and vaccine. Let’s wait and see.