In order to give full play to the resource advantages of Boao Lecheng International Medical Tourism Pilot Zone (Lecheng Pilot Zone) in Hainan Free Trade Port such as the policy on the import of drugs and medical devices urgently needed in clinical practice, the NMPA Drug and Medical Device Regulatory Science Research Base (Hainan Institute of Real World Data) and China’s first-ever Key Laboratory for Real-world Data Research and Innovation, Lecheng Pilot Zone will serve as the permanent site for the annual “Boao International Conference on Real-world Studies of Medical Products”.

The first Boao International Conference on Real-world Studies of Medical Products will be held on December 6-7, 2021. The event will gather resources such as drug regulators, academic institutions, scholars and experts, societies and associations and medical product producers at home and abroad to build a platform for real-world studies and medical products regulatory innovation, provide new methods, standards and approaches for promoting the use of real-world studies in regulatory decision-making of drugs and medical devices in China and the world and turn Lecheng Pilot Zone into a new highland of real-world studies and make China a global leader of real-world studies.

As the first Conference on Real-world Studies will be held, we had a special interview with Chen Pingyan, the executive director of Hainan Institute of Real World Data, who shared his personal views and practical experience on real-world studies.

On the occasion of the first Boao International Conference on Real World Research on Pharmaceutical Devices, we specially interviewed Chen Pingyan, Executive Director of Hainan Real World Data Research Institute, to share his personal views and practical experience on real world research.

Chen Pingyan, a professor, a doctoral supervisor, a post-doctoral co-supervisor, former director of the Department of Biostatistics, Southern Medical University (1997-2019 AD), who established the first department of biostatistics in China (in 2004) and opened the first undergraduate major of biostatistics in China (in 2005). The executive director of Hainan Institute of Real World Data. The director of the Biostatistics Branch of China Preventive Medicine Association, vice chairman of Chinese Branch of International Biometric Society, president of Guangdong Biometric Society; an expert for major administrative decision-making of Guangzhou. He has published over 280 papers, of which over 80 have been included in SCI and published in periodicals such as SMMR, SIM, NEJM, JCO, JAMA-IN, ERJ, JASN and Radiology, with a cumulative influence factor of over 500. He has been an editor-in-chief of the series of postgraduate program teaching materials of “SPSS Software Tutorials”, which boast a wide influence.

Question: What is real-world study?

Professor Chen Pingyan: In the Guidance on Real-world Evidence to Support Drug Development and Evaluation (Interim) issued by the National Medical Products Administration, real-world study is explicitly defined as “a research process where for preset clinical issues, data related with the health of the research object (real-world data) or summarized data derived from such data are collected from the real-world environment and later analyzed fully and properly to obtain the clinical evidences (real-world evidences) on the use, potential benefits and risks of drugs.” Simply speaking, real-world study is a research process from real-world data to real-world evidence.

Question: What are the differences between real-world study (RWS) and randomized controlled trial (RCT)?

Professor Chen Pingyan: I think there are mainly three differences. First, RCT belongs to interventional studies, while RWS mostly belongs to non-intervention studies, except for PCT and single-arm design. Second, RCT cases are randomized and can well balance the confounding factors, making the conclusion of causal inference certain. Most RWS cases are not randomized, making it difficult to fully control the impact of confounding factors, giving rise to the uncertainty in the conclusion of causal inference. Third, except in some rare cases, the conclusion of RCT is usually taken as the main supporting evidence for the researches on the registration of drugs and medical devices.

Question: What is the key and core to the standardized real-world study?

Professor Chen Pingyan: In carrying out a standard real-world study, we must pay attention to “three key conditions” and “avoid two biases”. The three key conditions are high-quality real-world data, good study design, correct statistical analysis and reasonable outcome interpretation. The “two biases” include data selection bias and result driven bias.

Question: How can real-world data become real-world evidence?

Professor Chen Pingyan: In essence, we should strictly observe the guidance related with real-world studies issued by the National Medical Products Administration in carrying out standard clinical researches. In the course of implementation, we should pay attention to the “three key conditions” and “two biases” mentioned above.

Question: What is the work status and next work focus of Hainan Institute of Real World Data?

Professor Chen Pingyan: Since Hainan Institute of Real World Data was established, it has mainly worked on three areas. First, basic work. To make the real-world studies in Lecheng feasible and sustainable, it has focused on building the real-world data platform in Hainan, which is expected to be completed and put into trial operation by the end of the year. Meanwhile, it has prepared for the establishment of Regional Ethics Committee for Real-world Studies in Lecheng. Second, it has provided all-round supporting services for the real-world studies carried out by medical product enterprises for the purpose of registration. Third, it has carried out academic researches in the field of real-world studies.

In the next step, the work focus of Hainan Institute of Real World Data will be to further perfect the real-world data platform and carry out more practical or theoretical real-world studies based on the platform.

Question: What messages do you want to express for the first Boao International Conference on Real-world Studies of Medical Products to be held at Lecheng in December?

Professor Chen Pingyan: May the first Boao International Conference on Real-world Studies of Medical Products be a great success. I wish that the good start of the event can lay a good foundation for it to become a famous international event.