Commissioned Programme on the CUHK Phase 1 Clinical Trial Centre at the Prince of Wales Hospital
Invited conference paper presented and published in conference proceedings


Other information
AbstractIntroduction and Project Objectives:
Phase 1 clinical trial is the foundation of translational research, bridging advances in basic science to clinical application. The objectives of the CUHK Phase 1 Clinical Trial Centre (P1CTC) are to: 1) develop an internationally recognized centre for conducting phase 1 clinical trials, 2) build a specialized team and nfrastructure to support phase 1 clinical trials, 3) promote knowledge transfer among stakeholders in drug development and 4) provide pharmacokinetic (PK)/ pharmacodynamic platform to support the development of investigational medicinal products (IMP), Traditional Chinese Medicine (TCM) and other complementary products.
Methods: The entire 11/F (EF block) of the Prince of Wales Hospital was converted into a P1CTC that comprises of 24 beds equipped with facilities for resuscitation and safety monitoring devices, 2 consultation rooms, recreational space, drug storage room, specimen-processing area, nurses stations and offices. Two liquid chromatography mass spectrometry machines were acquired to support PK work. The Centre was supported by a clinical team physicians, nurses, pharmacist, research assistant and workman) and an operation/ business development team. The Chief Director, 2 Medical Directors and 2 Deputy Medical Directors supervised the operation, research activities and strategic direction. The Centre was governed by the Faculty of Medicine, Clinical Research Management Office and Clinical Research Ethics Committee for adherence to Standard Operating Procedures and other practice policies. This safeguards accuracy and integrity of scientific output and ensured subject safety.
Results: From 2014 to 2019, the Centre completed 46 phase 1 clinical trials and recruited over 600 subjects. Thirty percent of these studies involved IMPs in oncology and 70% in hepatology, endocrinology , TCM and other disciplines. In August 2016, the Centre was recognised by China Food and Drug Administration (CFDA) for conducting clinical testing of pharmaceutical compound and 7 CFDA studies were completed. Other notable achievements included the establishment of a precision oncology program to molecularly match patients to anticancer drug trials, formation of the Asia-One Phase 1 Research Consortium in oncology and the launch of a webpage and e-platform for facilitating recruitment of healthy volunteers. The Centre hosted educational observerships for overseas visitors and masterclasses in Methods of Cancer Research.
Conclusion: The Centre was established in accordance to the objectives of the commissioned programme to support early phase evaluation of novel compounds. In our commitment to promote biotechnology development in Hong Kong, the Centre will continue to expand capacity and acilitate support to key stakeholders in drug development.
All Author(s) ListMa B, Luk AOY, Ozaki R, Chow EYK, Loong H, Chan FKL, Chan ATC
Name of ConferenceHealth Research Symposium 2021
Start Date of Conference23/11/2021
End Date of Conference23/11/2021
Place of ConferenceHong Kong
Country/Region of ConferenceHong Kong
Year2021
Month11
Day23
Place of PublicationHong Kong
Article numberAMR-37-50
Pages63 - 63
LanguagesEnglish-United Kingdom

Last updated on 2024-12-04 at 11:00