The first Boao International Conference on Real-world Studies of Medical Products (the first Conference on Real-world Studies) will be held on December 6-7, 2021. As the event is around the corner, we have hereby invited Sun Xin, the vice president of Hainan Institute of Real World Data, to share his opinions and practical experience on real-world studies.

Vice president of Hainan Institute of Real World Data;

Director, research fellow and doctoral supervisor with Chinese Cochrane Center of West China Hospital of Sichuan University;

Director of NMPA Key Laboratory for Real-World Data Research and Evaluation in Hainan;

Director of Sichuan Center of Technology Innovation for Real World Data;

Director of Cochrane China Center;

Director of MAGIC China Center;

Executive chief editor with Chinese Journal of Evidence-based Medicine and Journal of Evidence-based Medicine;

Chairman of Real-world Study Board, China Association of Traditional Chinese Medicine;

Vice chairman of Evidence-based Medicine Board, Chinese Medical Doctor Association

A winner of BMJ Outstanding Achievement Award (the first Chinese scholar to win this award).

What is the significance of real-world studies to medical enterprises and Lecheng Pilot Zone?

Professor Sun Xin: Real-world study can facilitate the development of medical enterprises in various aspects. Like, it can shorten the clinical research of medical products and save R&D costs for the enterprises. It can promote the development and clinical evaluation of TCM drugs and drugs for rare diseases, children and other special populations. It is helpful to the medical products monitoring and evaluation throughout their life cycle and can improve the product quality. Besides, real-world data based on specific diseases can support the improvement of clinical quality and promote the development and use of clinical guidance.

As a “business card” of Boao Lecheng Pilot Zone, real-world studies promote the Pilot Zone to become a new highland of monitoring innovation, medical innovation and talent aggregation under the support of the licensed medical product policy.

What is the key and core to the success of real-world studies?

Professor Sun Xin: In my opinion, the core and key to the success of real-world studies lies in the close cooperation among multidisciplinary teams. Real-world study shows a distinctive multidisciplinary attribute, which requires a comprehensive application of multidisciplinary methods and technologies such as epidemiology, biostatistics, evidence-based medicine and artificial intelligence. Meanwhile, clinical specialties are vital to the implementation and development of real-world studies.

In the past, the first medical product was approved for marketing in Lecheng Pilot Zone with the domestic real-world data, which could not do without the close cooperation of multidisciplinary teams like epidemiology and statistics methodology team, the clinical team of Wenzhou Medical University and CRO team. This February, the NMPA Key Laboratory for Real-World Data Research and Evaluation in Hainan was approved, which was co-built by three parties, namely West China Hospital of Sichuan University, Hainan Medical Products Administration/Boao ADR Center, Boao Lecheng Administration/Boao Super Hospital, as we always advocate collaboration and co-building among multiple parties and disciplines. In the future, we welcome more clinical teams and methodology teams to join the construction of the Key Laboratory and promote the innovation and practice of real-world studies.

What aspects need to be improved to truly support the evaluation and marketing of drugs and medical devices with real-world evidences?

Professor Sun: High-quality real-world data are a precondition for generating high-quality real-world evidence. At present, the processes of real-world data such as recording, collection, storage and linkage are to be further improved, which may still have problems such as data missing, data model and inconsistent standards. In terms of data analysis, we should make it more transparent and avoid manipulation of data. Besides, we should strengthen the construction of third-party platforms and systems to guarantee the public credibility of real-world study achievements.

How do you think of the application and prospect of real-world studies in China?

Professor Sun: In 2018, our team was invited to publish a payer on experience and lesson of real-world evidence in China in the British Medical Journal (BMJ). Compared with our investigation then, in recent years, real-world studies have developed rapidly in China. For example, under the great support of National Medical Products Administration, several guidelines for clinical evaluation of drugs and medical devices with real-world data have been released in succession, which play an important role in regulating the industrial development. As a key pioneering practical base for real-world studies in China, the Lecheng Pilot Zone has directly promoted the decision-making based on real-world evidences in China and realized the purposes of institutional innovation, industrial development and benefiting the people. Meanwhile, the application of real-world studies keeps deepening in such fields as drugs, health insurance, medical treatment, digital medical products and TCM drugs, as the healthcare industry attaches great importance to real-world data. We’re convinced that in the near future, real-world data will become an important impetus for the decision-making and development of drugs, medical treatment and health insurance industries. This will be the major development direction and content of the Key Laboratory. We hope to promote the work in these fields with our peers at home and abroad.

What is the current status of real-world studies in the world? At what level is real-world study in China?

Professor Sun: Today in the world, real-world study has become an important form of medical products administration. The FDA of the US has taken the initiative to issue a series of guiding documents. The health departments of other countries and regions such as the European Medicines Agency (EMA) and Pharmaceutical and Medical Devices Administration (PMDA) of Japan are picking up speed.

In recent years, Chinese regulatory authorities have attached great importance to real-world studies and striven to promote the application and development of real-world data in the regulatory decision-making of drugs and medical devices in China. We have set several major projects related with real-world data in the first and second batches of regulatory science programs of China, released a series of guidance for supporting clinical evaluation technology of drugs and medical devices with real-world data, promoted breakthroughs in the pilot programs of real-world data application at Lecheng Pilot Zone, and established China’s first key laboratory of real-world studies, NMPA Key Laboratory for Real-World Data Research and Evaluation in Hainan. Overall, China’s real-world study has been among the international first-class.

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 Sun: As one of the earliest teams involved in the real-world study practice of Boao Lecheng, we have been benefited from the great assistance and support from the National Medical Products Administration, Hainan Medical Products Administration and Lecheng Administration all the time. For this reason, we have had the opportunity to grow with Lecheng and witness its development miracle. We look forward to the Conference on Real-world Studies to be held in December. As a member, we sincerely wish that the event can be a successful one and it can further promote the vigorous development of real-world studies in China.