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The major difference between phase 1 clinical study and the later phases of clinical study is that its participants are usually healthy volunteers. Do you know the end-to-end procedure of preparing for a phase 1 study, and the steps that volunteers have to go through?

The video below will guide you through the journey of phase 1 clinical study, introducing you to all the details of this specific phase!

When you enrol in clinical trials, have you ever thought of why you might not be selected in some of them? Are you clear about the eligibility criteria of clinical trials? Read more about the eligibility, inclusion and exclusion criteria below!

Eligibility Criteria:

It includes a series of basic, medical, testing-related inclusion and exclusion conditions (such as age, height, weight, blood pressure, pre-existing medical conditions, etc.) to determine whether volunteers are suitable for participating in the study.

Inclusion Criteria:

Volunteers must meet the core requirements based on the research purpose. For instance, if the purpose of study is to obtain the safety data regarding a research drug being tested on Chinese subjects, the core criteria of volunteers is certainly the ethnicity.

Exclusion Criteria:

It refers to certain conditions that volunteers should not be having, and so will be excluded from the study. The criteria is established based on the study purpose, aiming at volunteer protection, and to eliminate any factors that may interfere with the research data or process. For instance, if a research drug may affect the eye function, even if a volunteer meets all the inclusion criteria, they may still be excluded from participating in the study if they have undergone corrective eye surgery.

Professor Leung Wai-Keung, the Chief Director of The University of Hong Kong Clinical Trials Centre (HKU-CTC) has shared insights in the latest HKU Bulletin issued in May 2024 on how HKU-CTC plays the role as a regional leader in the industry. 

About one-quarter of drugs approved by the US Food and Drug Administration (FDA) are tested at HKU-CTC and Mainland firms are increasingly using its services. We are now preparing for higher growth in the face of new opportunities and stiffer competition.

(Available in Chinese only)

(Available in Chinese only)

Sincere gratitude to all the volunteers participating in the study related to biological therapies targeting eosinophilic asthma earlier in 2019 (CTC1843), leading by the University of Hong Kong Clinical Trials Centre (HKU-CTC). We are thrilled to announce that the research data of the Phase III Study has already been submitted to the National Medical Products Administration (NMPA) for evaluation. This will certainly bring hopes to severe asthma patients if approval is granted by the NMPA eventually!

(Available in Chinese only)

(Available in Chinese only)

HKU-CTC has been walking together with Hong Kong in the past 25 years in advancing human healthcare. To commemorate this milestone, we held the silver jubilee celebration event earlier. The event brought together government officials, academic and industry representatives, as well as our dedicated colleagues in clinical research, with some 300 attendees. It was a joyous occasion started with speeches from Professor Richard Wong, Acting President & Vice-Chancellor of HKU, Dr. Stephen Wong, Head of Chief Executive’s Unit of HKSAR Government, Mr. Henry Fan, Chairman of Hospital Authority and Professor Leung Wai-Keung, HKU-CTC’s Chief Director, who commended the center's contributions to healthcare innovation in Hong Kong and its commitment to societal well-being. We also took the opportunity to express our appreciation to 10 colleagues who have been of service with HKU-CTC for 5 to 20 years, and congratulate our 5 trainees for their successful completion of our trainee programme during 2022-23. Let's take a moment to relive the highlights of this memorable evening!

(Available in Chinese only)