The HKU Phase 1 Clinical Trials Centre (HKU Phase 1 Centre), together with seven clinical specialties of its affiliated teaching hospital – Queen Mary Hospital (QMH), received official accreditation by the China Food and Drug Administration (CFDA) for conducting clinical drug trials. The HKU Phase 1 Centre is a dedicated, state-of-the-art clinical research facility of HKU Clinical Trials Centre (HKU-CTC), specifically designed for performing phase 1, early phase and clinical pharmacology trials. This accreditation signifies that research data and results arising from clinical trials conducted in the HKU Phase 1 Centre and the seven clinical specialties will be accepted by the CFDA for evaluation of applications for drug registration in the Mainland China, strengthening Hong Kong’s special position as a hub for drug research and development in China and worldwide.
Clinical Drug Trial Accreditation by the CFDA
Clinical trials are essential for medical advancement and are subject to stringent ethical and regulatory governance. Since 2006, HKU/QMH has been accredited by the CFDA for conducting clinical drug trials in seven clinical specialties (including anaesthesiology, cardiology, endocrinology & metabolism, haematology & bone marrow transplantation, hepatobiliary & pancreatic surgery/liver transplantation, obstetrics & gynaecology, and respiratory medicine). With the new accreditation for the HKU Phase 1 Centre and seven additional clinical specialties (including clinical immunology, gastroenterology & hepatology, nephrology, neurology, oncology, orthopaedics & traumatology, and paediatrics & adolescent medicine), HKU/QMH now is accredited by the CFDA in a total of 15 areas.
The accreditation for the HKU Phase 1 Centre is of exceptional significance as there was no official accreditation for any phase 1 centre in China.
Success of the HKU Phase 1 Centre
Drug development is a lengthy process involving drug discovery, pre-clinical research and phase 1 to 3 clinical trials. Phase 1 clinical trials constitute the earliest stage of investigation of novel drugs in research participants – whether patients or healthy volunteers – and represent a critical step towards practical advancement in medicine.
“The HKU Phase 1 Centre was established in 2014 with the support of the Food and Health Bureau and the Hospital Authority of Hong Kong. In a short period of only two years, the Centre has already completed eight trials. Now there are seven trials ongoing, and another 15 trials being planned. The major research areas include cancers, hepatitis, haematology and kidney diseases. The official accreditation by the CFDA represents the recognition of our clinical research works in the HKU Phase 1 Centre, adding strong momentum to Hong Kong’s clinical trial activities and drug research and development. Without doubt, we will see an upsurge in the volume of phase 1, early phase and clinical pharmacology trials here,” says Professor Karen Lam Siu-ling, Rosie T T Young Professor in Endocrinology and Metabolism, Chair Professor of Department of Medicine and Chairman of HKU-CTC, Li Ka Shing Faculty of Medicine, HKU.
“Patient safety and drug safety are our top priorities. We now have the excellent facilities and a dedicated team to evaluate new drugs safely. This is tremendous news for Hong Kong and our country,” says Professor Bernard Cheung Man-yung, Sun Chieh Yeh Heart Foundation Professor in Cardiovascular Therapeutics, Clinical Professor of Department of Medicine and Medical Director of HKU Phase 1 Centre, Li Ka Shing Faculty of Medicine, HKU.
Advancement in Medicine through Clinical Trials
“HKU/QMH has long been a leading institution in clinical trials, with outstanding reputation both locally and internationally. Over the years, HKU-CTC has developed into a professional clinical trial management organisation capable of running and supporting local and multinational clinical trials of various kinds. Accreditation by the CFDA is a significant acknowledgement of our clinical trials capabilities, in terms of clinical sciences, research ethics and research quality. With the joint effort of our clinical investigators, research institutions, the pharmaceutical industry and the HKSAR Government, and of course also the great support by our research participants, we are confident that medicine and healthcare will continue to advance and the public will be benefited,” says Professor Yu-lung Lau, Doris Zimmern Professor in Community Child Health, Chair Professor of Department of Paediatrics and Adolescent Medicine and Chief Director of HKU-CTC, Li Ka Shing Faculty of Medicine, HKU.
HKU-CTC is an academic clinical research organisation established under Li Ka Shing Faculty of Medicine, HKU in 1998, and is the central platform for management and coordination of clinical trials under HKU/QMH. It provides one-stop solutions for clinical research programmes – whether locally in Hong Kong or of a multinational scale. In collaboration with HKU’s expert investigators, local and overseas research institutions and the medical research industry, its professional team supports planning and management of various clinical trials – from designing research protocols, identifying suitable research participants, coordinating research procedures, collecting and analysing research data, to final reporting and publication of research results. Over the past 18 years, HKU-CTC has already facilitated over 1,100 clinical trials. HKU Phase 1 Centre was established by HKU-CTC in 2014 for performing phase 1, early phase and clinical pharmacology trials.
HKU-CTC has a robust governance and management system. Policies and strategies are directed by its Committee of Management (COM) with wide representation by the senior management of HKU/QMH. The COM now consists of 12 members including a Chairman, Dean and Associate Dean (Research) of the Medical Faculty, Hospital Chief Executive of QMH, Directors of HKU-CTC and other key stakeholders in clinical trials. The entire HKU-CTC now has a staff of 50 full-time clinical trial professionals covering a full spectrum of clinical trial expertise.
Enroll as Clinical Trial Participants
Any person who wishes to participate in clinical trials and support drug research and development, please visit HKU-CTC’s website (http://www.hkuctc.com/phase1_enroll_zh.php) for more details and registration.
HONG KONG and GUIYANG, GUIZHOU – 7th Apr, 2016 – The University of Hong Kong Clinical Trials Centre (HKU-CTC) and the Affiliated Hospital of Guizhou Medical University (GMUAH) today announced the establishment of a strategic collaboration on management of clinical trials in China. The objective is to develop a clinical study site management organization (SMO) model for facilitating the management and operation of international-standard clinical trials whilst fitting the specific local environment of China. This collaboration brings together the global clinical trial management experience of HKU-CTC and GMUAH’s local expertise in clinical trial operations, and is anticipated to contribute to the further advancement of international clinical trials and new drug development in the country.
“Protection of the rights and safety of research participants and safeguarding the quality of research data are the two core considerations in clinical trials. Over the past decades, the relevant standards have been getting more and more stringent – whether globally or locally. Enforcing compliance with such requirements has become an increasing challenge for clinical research centres and research personnel worldwide in terms of organizational management, human resources and financial resources. There is a pressing need for a practical solution, and a robust SMO model that supports full compliance in an efficient and sustainable manner is deemed the right way to go. Since its establishment in 1998, HKU-CTC has been investing major efforts in designing and developing a SMO model that supports the management and operation of international-standard clinical trials, and it has been proven a successful model through real implementation under HKU during the past 18 years. GMUAH is a well-established clinical research organization that has solid knowledge and experience in conducting clinical trials in China. Collaboration between GMUAH and HKU-CTC will integrate the expertise of the two parties, giving birth to a SMO model matching the practical needs of the country,” says Henry Yau, Managing Director and Honorary Assistant Professor of HKU-CTC.
“Development of the healthcare and innovation industries is a strategic direction of the Guizhou Province. Supporting novel drug research and development, including building clinical trial capabilities, aligns with this direction. Guizhou Medical College is dedicated to medical education and research, and GMUAH has been recognized as a national clinical drug trial institution by the China Food and Drug Administration (CFDA) since 2009. Over the years, we have been focusing on developing a professional platform for supporting clinical trials. We are very glad to collaborate with HKU-CTC, an internationally reputable clinical research management organization. I am confident that our common vision and complementary expertise will make a big success in developing a suitable SMO model that adapts to local needs and also contributes to the advancement of the healthcare and innovation industries in Guizhou and the whole country,” says Professor He Yan, Director of the GCP Office of GMUAH.
About HKU-CTC: HKU-CTC is a full-service academic clinical research management organization established under The University of Hong Kong since 1998, and is dedicated to promoting and facilitating international-standard clinical research in the region. Its novel SMO model is known to be effective for professional clinical study site management and has been taken as reference by hospitals/universities in Asian countries.
About GMUAH: GMUAH was founded in 1941 and is one of the earliest higher medical education institutions in the southwest region of China. It is now the largest 3A integrated hospital in Guizhou, providing a full range of medical services including clinical care, medical education, medical research, emergency services, rehabilitation and preventive medicine. Since 2009, GMUAH has been accredited by the CFDA as a national clinical drug trial institution in 15 clinical specialties.
Managing Director &
Honorary Assistant Professor
Clinical Trials Centre
The University of Hong Kong
The 2nd International Conference on Phase 1 and Early Phase Clinical Trials (ICPOEP 2015) was successfully held on 20 - 21 November, 2015 at Hyatt Regency Hong Kong, Tsim Sha Tsui in Hong Kong. About 340 delegates from five continents attended the conference and showed ideas about phase 1 and early phase clinical trials and drug development on an internatonal horizon.
Aligned with the theme of “New Drug Research for Tomorrow – In Asia and Worldwide”, our 18 distinguished speakers have brought a wide range of perspectives from their remarkable presentations. The panel discussion and Q&A sessions also attracted active discussions among speakers, session chairs, panelists and delegates by enthusiastic audience.
Please click here to visit the conference website.
On July 27, 2015, the Pearl Report, produced by TVB Pearl, about clinical trials in Hong Kong was aired.
The programme reviewed the recent development of clinical trials in Hong Kong, with special focus on phase 1 clinical trials. Renowned clinical investigators including Professor Karen Lam (Chairman, HKU-CTC), Professor Yu-lung Lau (Chief Director, HKU-CTC), Professor Bernard Cheung (Medical Director, HKU Phase 1 Centre), Dr. Tommy Cheung (Deputy Medical Director, HKU Phase 1 Centre) and Dr. Joanne Chiu (Deputy Medical Director, HKU Phase 1 Centre) explained the value and challenges of conducting clinical trials. Professor Sydney Tang (Chairman, HKU/HA HKW IRB) and Dr. Derrick Au (Director, Quality & Safety, Hospital Authority) illustrated the stringent research ethics review and approval mechanism. The importance of developing Hong Kong's clinical trial capabilities was highlighted by Professor Sophia Chan (Under Secretary for Food and Health, HKSAR) and Ms. Sabrina Chan (Executive Director, HKAPI). Volunteers in clinical trials also explained why they participated, and openly shared their experience in those trials.
The program will be broadcasted again at 11:35 am on 1st August, 2015 (Saturday), and is also available now online at http://programme.tvb.com/news/pearlreport/episode/20150727/.
In order to support clinical trials on novel drugs for various kinds of diseases, The University of Hong Kong Phase 1 Clinical Trials Centre (Phase 1 Centre) has been established last year. The Phase 1 Centre is a dedicated, state-of-the-art clinical research facility of HKU Clinical Trials Centre (HKU-CTC), specifically designed for conducting phase 1 and early phase clinical trials. With this advanced establishment, more high impact clinical trials will be conducted in the future and more novel treatments will emerge to combat different diseases – for the well-being of Hong Kong citizens and the mankind.
Importance of HKU Phase 1 Centre
“The Phase 1 Centre is a world-class clinical research facility with advanced equipment and a leading clinical, scientific and management team. It allows our investigators to conduct phase 1 and early phase clinical trials that were not possible in the past, and is going to be a powerhouse boosting novel drug research with results finally benefiting our patients and the public,” says Professor Karen Lam Siu-ling, Chairman of HKU-CTC and Rosie T T Young Professor in Endocrinology and Metabolism, Chair Professor and Head of Department of Medicine, Li Ka Shing Faculty of Medicine, HKU.
“The Phase 1 Centre is an ideal facility for clinical investigators to conduct clinical trials, in particular drug trials that require close monitoring. The team in the Phase 1 Centre is highly professional, not only in conducting research activities but more importantly in caring of our research participants,” says Professor Yuen Man-fung, Li Shu Fan Medical Foundation Professor in Medicine, Chair Professor of Gastroenterology and Hepatology, Department of Medicine, Li Ka Shing Faculty of Medicine, HKU.
Unique Value of Phase 1 Centre
Phase 1 and early phase clinical trials constitute the early stage of investigation of novel drugs in research participants – whether patients or healthy volunteers – and represent a critical step towards practical advancement in medicine. Such trials usually involve intensive and timely clinical assessments, diagnoses, blood sampling and testing, and commonly require continuous monitoring of trial participants – over 24 hours or even longer. Stringent quality control processes must also be implemented to ensure proper performance of each research procedure in compliance with research protocols, and also with local and international regulatory requirements. Without a dedicated, fully equipped and staffed facility, such trials could not be optimally carried out.
Achievements of Phase 1 Centre
Since the commencement of operation of the Phase 1 Centre in mid-2014, it has already supported three novel drug trials, in cancer and hepatitis. Currently four trials are ongoing there, and 12 other trials are under planning. The main research areas include cancers, hepatitis, immunology, diabetes and infectious diseases. So far over 70 participants have enrolled in the completed and ongoing trials. With the rapid advancement in medical research locally and worldwide, the number of phase 1 and early phase clinical trials conducted in the Phase 1 Centre is expected to keep growing in the years to come, and more new treatments will emerge.
Background of HKU-CTC
HKU-CTC is an academic clinical research organisation established under Li Ka Shing Faculty of Medicine, HKU in 1998, and is the central platform for management and coordination of clinical trials under HKU and its affiliated teaching hospital – Queen Mary Hospital (QMH).
HKU-CTC provides one-stop solutions for clinical research programmes – whether locally in Hong Kong or of a multinational scale. In collaboration with HKU's expert investigators, local and overseas research institutions and the medical research industry, its professional team supports planning and management of various clinical trials – from designing research protocols, identifying suitable research participants, coordinating research procedures, collecting and analyzing research data, to final reporting and publication of research results. Over the past 17 years, HKU-CTC has already facilitated over 1,000 clinical trials, covering oncology, cardiovascular diseases, gastroenterology & hepatology, endocrinology, diabetes & metabolism, haematology and other clinical specialties.
HKU-CTC has a robust governance and management system. Policies and strategies are directed by its Committee of Management (COM) with wide representation by the senior management of the Medical Faculty and QMH. The COM now consists of 12 members including a Chairman, Dean and Associate Dean (Research) of the Medical Faculty, Hospital Chief Executive of QMH, Directors of HKU-CTC and other key stakeholders in clinical trials.
The entire HKU-CTC now has a staff of 40 full-time clinical research management professionals under its six functional teams, including its Phase 1 Centre Operations Team, Pharmacokinetics Laboratory Operations Team, Business & Project Acceleration Team, Project Management & Contract Services Team, Quality Assurance Team and Corporate Services & Administration Team.
Enroll as phase 1 clinical trial participants
If you wish to participate in phase 1 clinical trials and support research and development of novel drugs, please visit HKU-CTC's website (http://www.hkuctc.com/phase1_enroll_zh.php) for more details and registration.
For press photos and powerpoint presentation, please visit the below link：
Clinical Trials Centre, The University of Hong Kong (“HKU-CTC”) – 5th January 2015 – HKU-CTC today announced that the trademark of PRACTISE® has been successfully registered with the Trade Marks Registry Intellectual Property Department, HKSAR on 5th January 2015 since its application made on 17th January 2014.
With the mission of advancing human healthcare by promoting, attracting and facilitating clinical studies, HKU-CTC is devoted to enhancing the quality of clinical studies by providing training to clinical investigators and study sites personnel under its proprietary training program - PRACTISE® (Professional Research Accreditation for Clinical Trials Investigative Site Executives). Over the last few years, PRACTISE® program or its individual modules has gained wide recognition by medical institutions and regulatory authorities in the Asian, Middle East and North African regions, including Hong Kong, Macau, Taiwan, mainland China, Malaysia, Vietnam, UAE and Egypt, which attracted the attendance of more than 1,000 participants.
“Our PRACTISE® program provides an interactive and intensive environment for efficient and effective learning and has been welcomed by many clinical research personnel from different regions. With the certification of registration of the PRACTISE® trademark, the intellectual property right of HKU-CTC will be better protected as it will keep the momentum to deliver PRACTISE® workshops in other countries in the coming years.” says Dr. Creany Wong, Co-chief Trainer of PRACTISE®.
About PRACTISE®: PRACTISE® is a comprehensive training program specifically designed for addressing the needs of clinical investigators, study coordinators and other study site personnel. The program includes 25 modules covering three key areas including (a) clinical trial concepts and compliance; (b) clinical trial preparation; and (c) clinical trial process. For details, please refer to http://www.hkuctc.com/knowledge_practise.php.
Dr. Creany Wong
Co-chief Trainer, PRACTISE®
Clinical Trials Centre
The University of Hong Kong
8th October, 2014 – The Clinical Trials Centre of The University of Hong Kong (HKU-CTC) announced the launch of its tailored Learning Management System (LMS) today.
Being a leading academic clinical research organization, HKU-CTC adopts the concept of total quality management (TQM). HKU-CTC’s LMS: (i) provides investigators, clinical research personnel and HKU-CTC’s staff a convenient access to a secure central platform for current policies, standard operating procedures (SOPs) and other quality documents via the internet anytime, anywhere; (ii) enhances compliance through close tracking of each individual’s training progress; and (iii) supports convenient documentation of completed training through maintenance of training records and generation of individual training transcripts.
It is anticipated that the LMS will enhance quality and compliance management in HKU-CTC and for clinical research at HKU and its teaching hospital (Queen Mary Hospital).
Functionalities of HKU-CTC’s LMS
- Secure central online platform for accessing the current policies, SOPs and relevant forms and document templates of HKU-CTC and study sites
- Training assignment and management, including training on internal policies/SOPs and external training courses/events
- Submission and endorsement of training reports
- Online examination on Good Clinical Practice (GCP) and clinical research ethics
- Maintenance of training records and generation of individual training transcripts
HONG KONG and Neuchâtel, Switzerland – 1st April, 2014 – The Clinical Trials Centre of The University of Hong Kong (HKU-CTC) and the Training and Resources in Research Ethics Evaluation Programme (TRREE) of the University of Neuchâtel, Switzerland announced formation of an international strategic collaboration today. The objective is to promote the principles of ethics and regulations of health and medical research involving human participants to research personnel, especially those in Asia, Middle East and North Africa. This collaboration brings together the research ethics expertise of the West and the East and integrates TRREE’s on-line e-Learning with HKU-CTC’s on-site training, and is anticipated to contribute significantly to protection of research participants and quality of human research in the Asian & MENA region and also globally.
Under the collaboration, HKU-CTC will contribute directly to the maintenance and future development of TRREE, and integrate TRREE into its on-site clinical research training programme. HKU-CTC will also work together with TRREE for attaining a better recognition of TRREE as a high-quality training programme on Good Clinical Practice (GCP) within the clinical research community and the pharmaceutical industry, while maintaining its independence and strong academic position. In addition, HKU-CTC will develop a Hong Kong Local Supplement for TRREE, which will provide direct access to Hong Kong’s human research legislation, regulations and ethical standards.
“Protection of research participants and quality management are two major elements of human research ethics. Over the years, HKU-CTC has been putting much effort in promoting research ethics and GCP. Our on-site training programme, namely PRACTISE®, provides an interactive and intensive environment for efficient and effective learning. TRREE, a high-quality, open platform freely accessible to research personnel anytime anywhere through the Internet, offers a desirable mode of continuous learning. We are proud to collaborate with TRREE, and trust the integration of TRREE’s on-line platform and HKU-CTC’s on-site training programme will create enormous synergy in promoting research ethics and GCP in the Asian & MENA region as well as globally,” says Henry Yau, Managing Director of HKU-CTC.
“Safeguarding research ethics is a continuous mission that requires international collaboration. I am very glad to know that HKU-CTC shares the same vision and has been making its effort in the Asian & MENA region which houses the biggest world population and plays an increasingly important role in human research. With our aligned vision and complementary expertise, I am sure this collaboration will bring solid value to the further development of research ethics in the region and also worldwide,” says Professor Dominique Sprumont, Coordinator of TRREE.
About TRREE: University of Neuchâtel (UniNE) is a public university in Neuchâtel, Switzerland. TRREE (www.trree.org) is an e-Learning and e-Resources platform initiated and coordinated by Professor Dominique Sprumont of the Institute of Health Law of UniNE for promoting the principles of human research ethics and regulations worldwide.
About HKU-CTC: HKU-CTC is a full-service academic research organisation established under The University of Hong Kong since 1998, and is dedicated to promoting and facilitating clinical research. Its proprietary on-site training programme – PRACTISE® (Professional Research Accreditation for Clinical Trials Investigative Site Executives) – is specifically designed for clinical investigators and research site personnel in the Asian & MENA region.
Clinical Trials Centre
The University of Hong Kong