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Study Intervention:

Any drug, medical device, medical method, or procedure aimed at treating, alleviating, diagnosing, or preventing diseases or medical conditions.

Adverse Event (AE):

An adverse condition that volunteers encounter during the research process (e.g., discomfort, symptoms of illness), regardless of whether the adverse event was expected or related to the research procedure or products. The research team must document, analyze, and follow up on each adverse event in detail.

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)

(Available in Chinese only)

(Available in Chinese only)

(Available in Chinese only)

(Available in Chinese only)