GBA International Clinical Trial Institute reaches new milestone with official establishment of Real-World Study and Application Centre and simultaneous launch of GBA Clinical Trial Collaboration Platform
The Health Bureau announced today (December 22) that the Greater Bay Area (GBA) International Clinical Trial Institute (GBAICTI), established and wholly owned by the Hong Kong Special Administrative Region Government, officially established the Real-World Study and Application Centre (RWSAC), and simultaneously launched the GBA Clinical Trial Collaboration Platform. This marks another significant step forward in promoting the co-ordinated development of the biomedical field in the GBA, following the simultaneous establishment of the GBAICTI and the GBA International Clinical Trials Center in Shenzhen under the "one institute, one center" model last year.
The RWSAC will leverage Hong Kong's unique advantages in medical data to enhance access to and the application of health and medical databases, and integrate real-world data generated under the special measure of using Hong Kong-registered drugs and medical devices used in Hong Kong public hospitals in the GBA (the Measure), with a view to supporting registration applications for innovative drugs and medical devices in Hong Kong, the Mainland and overseas, thereby accelerating product research and development (R&D), approval and market launch. As of December 10 this year, designated Mainland healthcare institutions (71 in total) under the Measure have introduced a total of 140 drug and medical device products listed in Hong Kong and Macao, comprising 63 drugs and 77 medical devices, benefiting over 17 000 patient visits.
To actively promote the development of multicentre clinical trials and real-world studies in the GBA, the GBAICTI has already commenced forward-looking planning; such as signing a tripartite Memorandum of Understanding with the LKS Faculty of Medicine of the University of Hong Kong and the international biopharmaceutical company GSK on September 9 this year to launch the GBAICTI's first real-world data research project. The project will start in Hong Kong and plans to gradually expand to other GBA cities such as Macao and Shenzhen. The RWSAC will strive to explore innovative pathways for using GBA medical data to support drug registration and market entry on the Mainland under the project, thereby accelerating the R&D and approval processes for innovative medical products. The project is currently in the protocol preparation stage, with data collection expected to officially commence in the second quarter next year, marking a critical step for Hong Kong in becoming an international hub for real-world studies and promoting the interconnectivity of medical data in the GBA.
In addition, the RWSAC will actively promote data application to support evidence-based decision-making, thereby optimising treatment strategies and enhancing healthcare system efficiency, and position Hong Kong as a leading region and international hub for real-world studies to attract global collaboration and investment. The scope of services of the RWSAC includes: (i) utilising real-world data to assess research feasibility and identify suitable research centres for clinical trials; (ii) providing comprehensive one-stop project management for real-world studies conducted in Hong Kong and other GBA cities; and (iii) offering expert consultation, professional training and capacity building in the field of real-world studies.
The simultaneously launched Collaboration Platform is a unified service portal jointly established by the "one institute, one center", aiming to integrate GBA clinical trial resources and provide a one-stop service entry point for global biomedical enterprises, R&D institutions and researchers. The Collaboration Platform will centrally handle service requests from the Mainland and overseas, and precisely match suitable research institutions and researchers based on specific needs through the Hong Kong Clinical Trial Digital Portal currently under construction. The platform also provides comprehensive expert consultation covering medicine, statistics, regulatory affairs and ethics review. Under this framework, the GBAICTI will strive to promote clinical trials of innovative therapies, focusing on rare disease drugs, high-end cancer drugs, and advanced therapy products such as cell and gene therapies. Furthermore, the Collaboration Platform will take on multiple roles, including serving as a key hub for collecting, storing and analysing real-world data and promoting pilot projects; acting as an information centre to establish a GBA clinical research talent pool and providing professional training courses including the Good Clinical Practice and advanced therapies. In the long run, it will help explore the possibility of the mutual recognition of ethics reviews through establishing a Shenzhen-Hong Kong collaborative mechanism and regularly exchanging review standards to enhance approval efficiency.
The GBAICTI will better integrate with the complete biomedical technology R&D and technology industry chain in the GBA, leverage the nation's special policy initiatives benefitting Hong Kong such as the Measure and relevant cross-boundary facilitation measures, and give full play to Hong Kong's role as a "super connector" enjoying strong support of the motherland and being closely connected to the world. It will promote the Hetao area as a window for translation of innovative biomedical research results to go global and attract foreign investment, expedite GBA patients' access to advanced treatments, and develop new quality productive forces.
The Health Bureau
