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Clinical research is an essence of medical advancement and a cornerstone of a robust health care system. In general, there are two types of clinical research – industry-sponsor studies and investigator-initiated studies (IISs) – whereas those initiated by investigators are increasingly important nowadays for its variety and diversity. They also bridge the research gaps on areas which are rarely covered by the industry. Facilitation of IISs is therefore a focus of The University of Hong Kong Clinical Trials Centre (HKU-CTC). In order to encourage investigators to initiate more high impact IISs, HKU-CTC has recently launched PRACTISE^® IIS – a training programme addressing the specific considerations for IISs.

The first course was completed by way of an online seminar on 28th August, 2020. Professor Ian Wong, Head of Department of Pharmacology and Pharmacy, and Dr. Helen Zhi, Director of Biostatistics and Clinical Research Methodology Unit, shared their practical tips and experience in designing and managing big data research and clinical studies with over 300 participants and received enthusiastic response. CTC will continue to organize other courses on IISs.

HKU-CTC is launching a Public Education Series explaining the process and particular of clinical trials by simple language and illustrations. The first chapter named “The Journey of Drug Development” was posted on HKU-CTC Facebook page on June 1, 2020.

(Available in Chinese only)

To help identify possible treatments for tackling COVID-19, The University of Hong Kong Clinical Trials Centre join forces with Queen Mary Hospital, Prince of Wales Hospital, Princess Margaret Hospital and the manufacturer of remdesivir, an investigational antiviral drug, in arranging for two clinical trials targeting for the treatment of moderate to severe COVID-19 patients. With a common goal of accelerating the preparation for the trials, the parties have been working hard in the past few weeks and quickly obtained the approvals from the research ethics committees. It is anticipated that the trials will be initiated within this month (i.e. March 2020).

HKU-CTC set up a Chinese New Year Booth at Queen Mary Hospital on 21st January, 2020, to celebrate Chinese New Year with the supporters. Dr. Hong, one of the CTC Panda Ambassadors, visited the booth on that day. He gave out calendar cards and fai-chuns to the visitors. Visitors who participated in the quiz game at the booth and answered all questions correctly were given specially designed red packets as well. The responses were enthusiastic. Here are some highlights of the event:

Novel coronavirus emerges in Hong Kong recently. Dr. Hong, Panda Ambassador of HKU Clinical Trials Centre, also wears a face mask to protect himself from viruses!

He wants to take this chance to remind you all to stay healthy and maintain personal hygiene to stop the spread of virus and avoid being infected. Dr. Hong is introducing you some useful tips:-

The investigational drug of this study is EXPAREL^®, a local anesthetic, which was approved by the US Food and Drug Administration (FDA) in 2011 on postsurgical pain relief. HKU-CTC was delegated to perform this study to evaluate the metabolic and safety profiles of this drug in Chinese population.

Recruitment of this study started in October 2019, and 20 healthy volunteers were recruited. The duration of this clinical study was around 54 days, including screening, 6-night confinement, ambulatory visits and a follow up phone call. During the study period, volunteers received one dose of the investigational drug via subcutaneous injection at multiple points. Due to the long staying period, HKU-CTC organized 3 workshops for the healthy volunteers, including Turkish Mosaic Lamp Workshop, Little Paper Art Night Lamp Workshop and Art of Paper Tearing Workshop. The project was completed in January 2020.

The ICN Annual Steering Board Meeting 2019 took place on September 26, 2019 in Freiburg, Germany and was hosted by Clinical Trials Unit Freiburg of University Hospital Freiburg, one of the founding members. During the meeting, all steering board members reported their recent activities, and together formulated an action plan for the coming year through intensive small group discussions and open exchange of ideas over panel meetings. Mr. Henry Yau, Managing Director of HKU-CTC, was elected the new ICN Vice-Chairperson and will work together with the new Chairperson, Dr. Thomas Hiemstra of Cambridge Clinical Trials Unit and other Steering Board members to contribute to ICN’s exciting development in the coming two years.

The ICN Symposium 2019 was held following the Steering Board Meeting. Twelve speakers from Germany, United Kingdom, Switzerland, Sweden, Turkey, Taiwan and Hong Kong shared their insightful ideas around the theme of “Clinical Trials in the Global and Digital World”. Mr. Henry Yau, our Managing Director, and Dr. Creany Wong, our Associate Director, shared their experience on “clinical trials central management and digitalization” and received enthusiastic responses from the floor.

The next ICN Steering Board Meeting and Symposium will be hosted by HKU-CTC in November 2020 in Hong Kong.

When most people think of medical careers, the life of a practicing doctor immediately come to mind. However, there is also a very different option in the medical field which involves an alternative pathway: be a medical researcher.

30 students who are newly admitted to the HKU Bachelor of Medicine and Bachelor of Surgery Programme (MBBS) this year visited HKU Phase 1 Clinical Trials Centre on July 8, 2019. An information session introducing the concepts of clinical research was delivered by Dr. Creany Wong, Associate Director of HKU-CTC, followed by a tour around the Centre.

The students reflected that it was an eye-opening experience as they had never thought of the possibility of entering the research field after the completion of a medical degree. Some considered that it could also be another way to contribute to the society and to the betterment of mankind.

The investigational drug, Benralizumab, is a novel drug for treating asthma. It was approved in USA, European Union, Japan and Canada. HKU Clinical Trials Centre conducted the phase 1 clinical research of the drug to evaluate the metabolism and safety of the drug using different doses in Chinese population.

Recruitment started in March 2019 and 36 healthy volunteers were selected to join the study. The whole study took 17 weeks and it included screening, 3-day-2-night confinement and follow-up visits. Volunteers were divided into 2 groups to receive injection. The research was completed in August 2019.