Mission

To undertake clinical trials to internationally accepted standards of scientific excellence and support related clinical research programmes in Hong Kong and Asia that will lead to the reduction of the morbidity and mortality of various diseases.

Organization Chart of CCT

Staff

About the Centre for Clinical Trials

The Centre for Clinical Trials was established in 2003 under the School of Public Health to promote high quality clinical trials. The Centre aims to provide a research infrastructure to support local, regional and international clinical trials carried out in Asia. The Centre is ideally suited and uniquely positioned to take advantage of the global trend of clinical drug trials development in Asia.

Number of Clinical Trial conducted in the Chinese University of Hong Kong

Number of Clinical Trial conducted in the Chinese University of Hong Kong by Discipines

Service Provided

Overview

The Centre for Clinical Trials provides efficient and quality services to support local, regional and international clinical trials activities. We provide a wide range of services to pharmaceutical and biotechnology companies interested in developing clinical trials, as well as to the University. These include:

• Acting as an academic contract research organization (Academic CRO) for pharmaceuticals & biotechnology companies;
• Support faculty with sound design methodology and analysis of clinical trials;
• Infrastructure for conducting clinical trials;
• Quality control and quality assurance;
• Education & training;
• Promotion of clinical trials methodology through research in biostatistics methodology, data management, quality of life, quality control and assurance, bioinformatics, etc.;
• Trials registration.

Academic Contract Research Organization (Academic CRO)

CCT’s main role is to act as an Academic Contract Research Organization (Academic CRO) to continuously improve the quality of clinical trials activities undertaken at CUHK. Our tasks include:

• Identify Investigators for Sponsors

CCT offers site selection services across Hong Kong, Mainland China and Asia. Our experienced staff are able to quickly recruit investigators. We also provide a preliminary evaluation of investigators’ qualifications and other study personnel, and assess the ability of a prospective clinical site to perform the proposed study.

• Negotiate Contracts with Sponsors

CCT helps investigators negotiate contracts and also facilitates sponsors to quickly and effectively negotiate contracts.

• Regulatory Affairs

CCT provides services to comply with regulatory requirements, including applications for drug import/export licenses, clinical trials certificates, ethics and local consent forms, which are translated if necessary. Our dedicated regulatory affairs professionals ensure the successful and timely submission of all applications. As a poorly prepared submission can result in delays, or even rejection of the application, we meticulously review each submission to ensure nothing is missed, and compile each submission in accordance with the stipulated regulatory requirements. We are also alert to any possible change in regulatory guidelines and requirements, and adapt our services to take into consideration emerging trends in submission procedures and technologies.

• Statistical Centre for Multi-centre Trials

CCT acts as Statistical Centre for multi-centre clinical trials. We understand the concerns of researchers, institutions and the industry. We provide high quality and cost-efficient services on protocol and case report form development, study coordination, quality control, SAE reporting, drug supply, data management, statistical analysis, data validation and research report writing.

• Protocol and CRF Development

CCT has amassed a wealth of experience in creating optimal study designs and in developing protocol and case report forms for research programmes that extend from dose-finding safety and efficacy studies, to large sample-size registration trials. Our personnel have the experience and the knowledge in all areas of clinical research, biostatistics, and regulatory issues to lead the design of each study as required. Our protocol and CRF development services are governed by rigorous SOPs and comply with ICH-GCP guidelines.

• Data Management

CCT is dedicated to provide its clients with secure, regulatory-compliant, flexible and cost-effective data management services including: database design, data validation, data entry and medical / science review. Our data management services are governed by rigorous SOPs to ensure the integrity and accuracy of study data.

• Biostatistics Services

CCT has a dedicated biostatistics team. CCT's biostatisticians follow corporate SOPs to ensure the consistency and integrity of study results. Our biostatistics services include the following:

1. Centre for Clinical Trials provides Web-based randomization services to research partners, which support various methods including permuted block randomization and minimization. Drug dispensation can also be arranged with sponsors and we have the capability to carry out randomization for double-blind randomized trials.
2. CCT is active in biostatistics methodology research, especially in trials design.
3. Analysis and reporting of Phase I-IV clinical trials of various designs to match the objectives of the study.
4. Sample size estimation.
5. Periodic data monitoring and safety reviews.
6. Interim and final analyses.
7. Statistical consulting.

• Sites Monitoring

CCT offers monitoring services for clinical trials, adverse events and serious adverse events. Site monitoring ensures protocol and regulatory compliance. Moreover, the timely submission of high-quality data ensures facilities and staff at the investigational site continue to be acceptable for the study.

Auditing

CCT provides auditing services on behalf of sponsors. The purpose of a trial audit is to perform a systematic and independent examination of trial-related activities and their documentation. This will determine whether a clinical trial was conducted properly, and whether clinical data were recorded accurately, analyzed and reported according to protocol, the sponsor's SOPs, good clinical practice (GCP) and the applicable regulatory requirements.

Clinical Trials Registration

CCT has established a Web-based Clinical Trials Registry to provide all prospective registrants with a convenient means to submit trial information. Our registry is in compliance with ICMJE trial registration policy, and has also obtained recognition from New England Journal of Medicine (NEJM). The WHO International Clinical Trial Registry Platform (ICTRP) is being set up to certify registers around the world. ICTRP certified registers are acceptable to the ICMJE. CCT has signed up for the programme and the project is under development.

Tial Registry Web-site

Information Technology Development for Clinical Trials
Data Management

The information technology (IT) system includes computer servers networked through the University’s infrastructure and protected behind a firewall to allow Web-based applications to handle clinical trials operations. We are currently using Oracle Database for data management and SAS for statistical programming and analysis. Our off-site Data Centre provides access around the clock, seven days a week, and has a proven track record for being secure and efficient.

We understand the requirements and logistics involved in clinical trials operations and are capable of using advance IT technologies to increase the efficiency of trials’ operations and to reduce cost. Examples include: 1) Randomization; 2) Remote data entry; 3) Pocket PC logging system; 4) Central SAE database; 5) SAE reporting system; 6) SAE sub-committee reviewing system for the Clinical Research Ethics Committee; 7) Workflow system for project management.

Data Centre Facilities

• 24x7 standby support in addition to CPCNet
• 10 Mbps shared bandwidth
• Daily tape backup services
• FM 200 gas-based fire suppression system and smoke alarms
• CRAC air conditioning and humidity control
• AC power supply at 240V, 50 Hz
• N+1 UPS with battery backup
• 24x7 free access and support from CPCNet
• 24x7 security control

Unique Biostatistics and Bioinformatics Research

CCT is unique because we have a strong biostatistics research background and understand the concerns of researchers, institutions and the industry. We provide Biostatistics Consultation for U.S., Canadian and European pharmaceuticals and biotechnology companies, and are experienced in working with National Cancer Institute (NCI) Investigational New Drug (IND) programme. We are also active in biostatistics methodological research, with projects including, for example: 1) Design of multiple endpoints for phase II clinical trials; 2) Interim analysis with mixed multiple endpoints; 3) Phase II trial design; 4) Quality of life with missing data; 5) Data management methodological research.

Bioinformatics methodological research includes the development of a new statistical approach to analyze microarrays and pharmacogenomic data.