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HKU Phase 1 Clinical Trials Centre receives clinical drug trial accreditation by the China Food and Drug Administration

03 Aug 2016

A photo of the team of HKU Phase 1 Clinical Trials Centre.

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.

About 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/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.

Please visit the website at http://www.med.hku.hk/v1/news-and-events/press-releases for press photos.

The delegation of China Food and Drug Administration (CFDA), led by Mr Wu Zhen (7th right), Vice Minister of CFDA, visited HKU Phase 1 Clinical Trials Centre on July 25, 2016 and was welcomed by the team led by Professor Karen Lam Siu-ling (8th left), Rosie T T Young Professor in Endocrinology and Metabolism, Chairman of HKU Clinical Trials Centre and Chair Professor of Department of Medicine, Li Ka Shing Faculty of Medicine, HKU.

HKU Phase 1 Clinical Trials Centre received Clinical Drug Trial Accreditation by 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.

HKU Phase 1 Clinical Trials Centre will continue to run and support local and multinational clinical trials of various kinds.