Established in 2017, the Clinical Trials Centre (CTC) is the first of its type in the local private sector as well as the fourth institution in Hong Kong accredited by the National Medical Products Administration (NMPA). Also accredited by NMPA is the specialty of comprehensive oncology at Hong Kong Sanatorium & Hospital (HKSH), which has been allowed to conduct NMPA-related clinical trials since April 2019.
HKSH is also the first and currently the only NMPA-accredited private hospital in Hong Kong. The clinical data of its Comprehensive Oncology Centre is recognised for conducting new drug assessments.
By registering on the NMPA Platform, HKSH can conduct relevant clinical trials at CTC and gain access to world-renowned pharmaceutical companies for collaboration. Since its inception in 2017, CTC has received enquiries about clinical drug trials from major corporations such as AstraZeneca, Gilead, Arcus Biosciences, Stemline Therapeutics, etc.
With equipment on par with international standards, all verified and registered by CTC for clinical trials, similar enquiries have also come from other scientific research institutions and patients interested in participation. HKSH specialists have also been invited to share their experiences and results at seminars and sharing sessions.
Milestones
Completion of On-site Inspection of An Oncology Clinical Trial by the Drug Office of HKSAR Department of Health
3rd Year’s Contribution to the National Medical Products Administration Yearbook, a Recognition for CTC in the Field of Clinical Trials
HKSH’s representatives attended the Opening Ceremony of the Greater Bay Area International Clinical Trial Institute, marking HKSH’s contributions to clinical trials
Setup of Clinical Trials Unit for Inpatient Clinical Trials
First Investigator-initiated Clinical Trial Approved by REC
First Sponsored Clinical Drug Trial Approved by Research Ethics Committee (REC) after NMPA Accreditation
Hong Kong Sanatorium & Hospital became the first local private hospital accredited by the National Medical Products Administration (NMPA), which also recognised the clinical trial data from our oncology specialty for new drug assessment
Establishment of Clinical Trials Centre (CTC)
Understanding Clinical Trials
What are Clinical Trials?
Clinical trials are research studies that engage human participants to evaluate the effects of new medications, devices, or other treatments. Before any treatment is made available to the public, it must undergo a thorough clinical trial process to:
- Determine Efficacy: Clinical trials verify the effectiveness of the treatment for a specific disease or condition.
- Evaluate Safety: Clinical trials help understand the potential side effects to evaluate treatment safety.
- Optimise Dosages: Clinical trials enable researchers to establish optimal dosages that maximise benefits and minimise adverse effects.
Phases of Clinical Trials
Clinical trials are generally conducted in four phases, with each phase collecting and analysing data for different research objectives:
- Preclinical Phase: Before testing on humans, the new treatment is studied in the laboratory and on animal models to evaluate its safety and biological activity.
- Phase 1: This initial phase of human trials involves a small group of healthy volunteers or patients (typically 20 to 100). The focus is on assessing the treatment's safety, determining side effects, and identifying the highest dose that can be tolerated without serious adverse effects. Researchers also study pharmacokinetics (i.e. how the human body absorbs, distributes, metabolises, and excretes the drug).
- Phase 2: In Phase 2, the drug or treatment is administered to a larger group of patients (up to several hundreds). This phase aims to evaluate the efficacy of the treatment for specific conditions while continuing to assess safety.
- Phase 3: Phase 3 studies involve an even larger group of patients (ranging from several hundreds to several thousands) to confirm the treatment's efficacy, compare it with standard treatments, and collect comprehensive safety data. Successful completion of Phase 3 is typically required for the treatment to receive regulatory approval.
- Regulatory Approval and Registration: After successful completion of Phase 3, the new treatment undergoes regulatory review by authorities, such as the US’s FDA, China’s NMPA, or Hong Kong’s Department of Health. If approved, the drug or treatment is registered and authorised for market release. This stage includes a comprehensive review of all clinical trial data to ensure that the treatment meets the required efficacy and safety standards.
- Phase 4: After a drug or treatment is approved by a regulatory body, e.g. US’s FDA, China’s NMPA, Hong Kong’s Department of Health and becomes available on the market, researchers would conduct Phase 4 studies, i.e. post-market studies, to continue monitoring its safety and effectiveness in a broad, real-world population.
Participating in a Clinical Trial
Informed Consent
Before you participate in any clinical trial, you will go through an informed consent process. This fundamental ethical requirement ensures you are fully informed about the study's nature, purpose, procedures, potential risks, and benefits. During this process, the research team will provide detailed information and address any questions you might have. You will be asked to sign an informed consent document, which confirms your understanding and agreement to participate in the study. Signing this document is completely voluntary, and you retain the right to withdraw from the study at any time without penalty.
Eligibility Criteria
Each clinical trial has a specific set of eligibility criteria to determine participant suitability. These criteria are crucial for ensuring the safety of participants and the integrity of study results. Before initiating any study treatment, your doctor and research staff will conduct screening assessments to confirm whether you meet these criteria. Assessments may include a physical examination, blood tests, and imaging scans. If you successfully meet the requirements during this initial screening, you will be formally enrolled in the trial.
Participant Safety
Ensuring participant safety is the foremost priority in clinical trials. Before a trial can commence, it must receive approval from an Institutional Review Board (IRB) or a Research Ethics Committee (REC), which evaluates the study's safety measures and ethical considerations. Throughout the trial, your health and wellbeing will be regularly monitored according to strict study protocols. You are encouraged to report any adverse events you experience and maintain open communication with your study doctor.
Ongoing Clinical Trials (Oncology)
Breast
| Elacestrant versus Standard Endocrine Therapy in Women and Men with Node-positive, Estrogen Receptor-positive, HER2-negative, Early Breast Cancer with High Risk of Recurrence - A Global, Multicenter, Randomized, Open-label Phase 3 Study (ELEGANT) | ||
| Study Status Active | Enrollment Status Recruiting | |
Clinical Trial SummaryDisease
| Protocol No. STML-ELA-0422 NCT No. NCT06492616 Principal Investigator Dr. Amy Chang | |
| * Note: Additional eligibility criteria apply. Information may not be fully updated. For more details, please contact the study team. | ||
| A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician’s Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer, Whose Tumors Express PD-L1 (ASCENT-04) | ||
| Study Status Active | Enrollment Status Recruitment closed | |
Clinical Trial SummaryDisease
| Protocol No. GS-US-592-6173 NCT No. NCT05382286 Principal Investigator Dr. Chun Chung Yau | |
| * Note: Additional eligibility criteria apply. Information may not be fully updated. For more details, please contact the study team. | ||
Liver
| A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of Durvalumab Monotherapy or in Combination With Bevacizumab as Adjuvant Therapy in Patients With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation (EMERALD-2) | ||
| Study Status Completed | Enrollment Status Recruitment closed | |
Clinical Trial SummaryDisease
| Protocol No. D910DC00001 NCT No. NCT03847428 Principal Investigator Dr. Thomas Leung | |
| * Note: Additional eligibility criteria apply. Information may not be fully updated. For more details, please contact the study team. | ||
Clinical Trials Centre
- Address:
- 8/F, Li Shu Fan Block,
Hong Kong Sanatorium & Hospital,
2 Village Road, Happy Valley, Hong Kong
- Service hours:
-
Monday - Friday: 9am - 5pm
Consultation by Appointment
- Tel.:
- (852) 2835 3778
- Email:
- [javascript protected email address]