Lecheng Hosts 2021 Closed-Door Symposium on Clinical and Real-World Data Research, Advocating Enhanced Collaboration and Innovation

On June 17, 2021, the Boao Lecheng International Medical Tourism Pilot Zone Administration, the China Clinical Research Consortium, and the Hainan Institute for Real-World Data jointly hosted the “2021 Lecheng Closed-Door Seminar on Clinical Research” in the Lecheng Medical Tourism Pilot Zone. The seminar aimed to advance the development of the Lecheng Pilot Zone in fields such as clinical research and real-world studies. Participants engaged in in-depth discussions on how to better pool resources from all parties, establish positive interactions between the Lecheng Pilot Zone and entities outside Hainan Province in areas like scientific research collaboration and industrial synergy, explore innovative models for clinical research, promote the development of real-world studies, and facilitate the introduction of internationally advanced pharmaceuticals and medical devices into the Hainan Lecheng Pilot Zone.

Liu Zhefeng, Deputy Director of the Administration Bureau of Boao Lecheng International Medical Tourism Pilot Zone, attended today’s symposium and delivered opening remarks. Yao Chen, Deputy Director of the Hainan Institute for Real-World Data Research, introduced relevant policies on real-world data research and provided an overview of real-world data research projects in Lecheng.

Attendees included Han Wenxin, Co-Convenor and Secretary-General of the China Clinical Research Consortium; Professor Weng Jianping, Co-Convenor of the China Clinical Research Consortium and Executive President of the Chinese Academy of Sciences Clinical Research Hospital (Hefei); Feng Qingming, Chief Medical Officer of General Global Healthcare Group, a founding member of the China Clinical Research Consortium; Yuan Peng, National Head of China Life Insurance Group’s Guoshou Jiayuan, a member unit of the China Clinical Research Consortium; Dr. Fan Xiaodong, former Executive Deputy Director of the Center for Medical Device Evaluation of the National Medical Products Administration; Professor Zeng Yu, Dean of the Hainan Nanhai Health Industry Research Institute; Gong Nan, Senior Partner at Beijing Bairui Law Firm; and Wang Jingjing, Director of the Global Health Industry Innovation Center (GHIC). These distinguished guests shared insights and engaged in discussions on special topics including “Relevant Policies for Clinical Research and Real-World Studies,” “Key Issues in Conducting Clinical Research and Real-World Studies,” “Collaboration and Support in Clinical Trials and Real-World Studies,” and “Pharmaceutical and Medical Device Companies’ Needs for Clinical Trials and Exploration of Cooperation Models Between Stakeholders and Enterprises.”

The Boao Lecheng International Medical Tourism Pilot Zone serves as China’s pioneering hub for real-world study (RWS) initiatives. The “Technical Guiding Principles for Using Real-World Evidence in the Clinical Evaluation of Medical Devices (Trial)” (Document No. 77, 2020), issued by the National Medical Products Administration (NMPA) in November 2020, demonstrates that the timing for piloting the application of real-world data (RWD) in medical device clinical evaluations is gradually maturing. In late November 2020, the NMPA’s Scientific Research Base for Drug and Medical Device Regulation, located within the Lecheng Pilot Zone, was officially unveiled, and the Hainan Institute for Real-World Data was established. The Lecheng Pilot Zone will prioritize efforts in real-world studies to further advance the use of real-world evidence (RWE) in regulatory decision-making and the registration of pharmaceuticals and medical devices. At this symposium, participants generally agreed that the Lecheng Pilot Zone possesses inherent policy and technical advantages for conducting RWD research. However, they also emphasized the need for greater resource mobilization, along with the involvement of more experts and patients, to collectively promote the development of real-world data research in the Lecheng Pilot Zone.

At this symposium, the China Clinical Research Consortium and the Hainan Institute for Real-World Data discussed their collaboration model and reached an intent to cooperate. The China Clinical Research Consortium will leverage its strengths in expertise, scientific research, translation, and industrial implementation, while combining these with the Hainan Institute for Real-World Data’s professional advantages in real-world data research and the locational benefits of the Hainan Free Trade Port. Both parties will jointly work to strengthen exchanges and interactions between the Boao Lecheng International Medical Tourism Pilot Zone (hereinafter referred to as the Lecheng Pilot Zone) and other provinces in areas such as scientific research and industrial development. This effort aims to help more advanced pharmaceutical and medical device companies establish operations in the Lecheng Pilot Zone, accelerate clinical development, and expedite the translation and implementation of research outcomes. Furthermore, both parties will collaborate to promote the conduct of real-world data studies on more advanced pharmaceutical and medical device projects within the Lecheng Pilot Zone and publicize the achievements derived from these real-world data studies.

This seminar marks the first event of its kind held in the Boao Lecheng International Medical Tourism Pilot Zone since the China Clinical Research Consortium was jointly initiated by six parties—the Administration Bureau of Hainan Boao Lecheng International Medical Tourism Pilot Zone, the Chinese Academy of Sciences Clinical Research Hospital (Hefei), General Global Medical Group, CCD Strategy Group, Health界 (Health Circle), and the Boao Institute for Medical Innovation—at the end of 2020, with the first batch of member units confirmed in the first quarter of 2021. The China Clinical Research Consortium is currently the only national ecosystem in China’s clinical research field collaboratively built by multiple stakeholders from government, healthcare, industry, academia, research, and finance.

In addition to the three organizers, co-organizers Yiling Hospital Management Group and Boao Yiling Life Care Center, participating enterprises including Hainan Boao Lecheng Clinical Research Center, Danaher, Bayer, and Astellas, as well as other multinational pharmaceutical and medical device companies, and the undertaking entity Hainan Xieli Health Management Co., Ltd., jointly issued an initiative to fully support the Clinical Research Conference hosted by the National Medical Products Administration in Boao on December 6–7.

The China Clinical Research Consortium was jointly initiated by six parties: the Hainan Boao Lecheng International Medical Tourism Pilot Zone Administration, the Chinese Academy of Sciences Clinical Research Hospital (Hefei), General Universal Medical Group, CCD Strategy Group, CN-Healthcare, and the Boao Institute for Medical Innovation. The Consortium aims to establish an ecosystem of cooperation and mutual assistance among government agencies, medical institutions, academic organizations, researchers, enterprises, and financial institutions. Through collaborative, empowering, compliant, and innovative platform-based operations, it leverages the respective strengths of all parties, pools diverse resources, and jointly promotes the development of clinical research in China, thereby benefiting more patients.

Since its inception in late 2020, initiated by the aforementioned six founding parties, the China Clinical Research Consortium has received enthusiastic support from various sectors of society. In addition to the six founding initiators, the first batch of members joining the Consortium includes provincial public medical institutions such as Sichuan Provincial People’s Hospital and Anhui Provincial Hospital; relevant research teams from ministries-affiliated and local universities and academies, including the Chinese Academy of Medical Sciences, Peking University, Capital Medical University, Fudan University, Shanghai Jiao Tong University, University of Science and Technology of China, Sun Yat-sen University, Zhejiang University, Sichuan University, Southeast University, Jinan University, and Shanghai University of Traditional Chinese Medicine; subordinate institutions of central state-owned enterprises such as China Merchants Group and China Life Insurance; leading service enterprises in fields related to clinical research, such as WuXi AppTec and WeDoctor; and professional social organizations, including the China Cardiovascular Health Alliance, the China County Hospital Presidents Alliance, the Interventional Branch of the Chinese Medical Doctor Association, the China Diabetes Innovation Alliance, the Shanghai Strategic Alliance for Technological Innovation in Rehabilitation Aids and Elderly Welfare Industries, the Sichuan International Medical Exchange Promotion Association, and the Guangdong Precision Medicine Industry Technology Innovation Alliance.

1) Establish a Clinical Research Platform

By leveraging and coordinating top-tier resources from medical institutions, pharmaceutical and medical device enterprises, CROs, and other key stakeholders in clinical research, we will jointly establish an innovative platform for clinical studies. We will fully capitalize on the policy advantages of regions such as Hainan, the Guangdong-Hong Kong-Macao Greater Bay Area, and Shanghai Lingang to develop a quality control and certification system for clinical research that meets leading domestic and internationally advanced standards. Furthermore, we will build a collaborative network among hospitals conducting clinical trials to promote the innovation and dissemination of clinically appropriate technologies, thereby collectively advancing the development of clinical research.

2) Promote real-world studies on innovative drugs and medical devices

Leveraging the Chinese Clinical Research Consortium, we assist relevant stakeholders in conducting real-world studies of pharmaceuticals and medical devices, explore mechanisms for the introduction, pilot use, and promotion of innovative products, streamline the fast-track approval pathway via real-world evidence, accelerate the market launch of domestic and international innovative pharmaceuticals and medical devices, and establish a robust, replicable operational model.

3) Facilitate the translation and implementation of medical technology achievements

The China Clinical Research Consortium will leverage the industrial support policies of its partner regions and its abundant medical innovation resources while building an innovative clinical research system. It aims to identify, incubate, and empower domestic and international clinical technology projects, actively facilitating the translation and promotion of outstanding clinical technologies.

4) Build an International Brand

The Chinese Clinical Research Consortium will also integrate resources from various stakeholders to establish a promotional and dissemination platform with global influence. Aligned with its strategic planning, the Consortium will organize multi-level, diverse exchange activities—including large-scale international summits, specialized exchange forums, targeted expert seminars, and closed-door meetings—to build internationally renowned event brands and support the development of clinical research in China.