The number of clinical trials taking place globally has increased substantially over the past decade. In the United States, spending on clinical trials in 2002 totalled just $15 billion. (Figure 1) this figure jumped to nearly $24 billion in 2005 and to $25.6 billion in 2006. According to a report by BCC Research, “Pharmaceuticals Clinical Trials Business,” spending on clinical trials in the U.S. is forecast to rise to $32 billion by 2011, based on a projected average annual growth rate of 4.6%. (Figure 2)

Figure 1	Figure 2
Number and Spending of Clinical Trials in the U.S.	Historical and Projected Spending for Clinical Trials in the U.S.

Government spending on clinical trials, however, has been considerably less. The National Institutes of Health, the United States’ medical research agency, spent about $2.9 billion on clinical trials in 2005, and budgeted $3.0 billion for 2006.

The rapid development of new drugs, a trend being driven by the industry, has changed the conventional drug development process, long dependent on government support. This global shift is forcing academic institutions to rethink how they operate. It is also compelling them to upgrade their infrastructure to comply with regulatory requirements.

The Centre for Clinical Trials (CCT) of the Chinese University of Hong Kong (CUHK) is embracing these developments. Established in 2003, our mission is to contribute to clinical research methodology, and to participate in a wide range of data management projects up to ICH-GCP standards. In addition to industry trials, our highly experienced staff also strive for excellence in Cooperative Group Trials, andtrials that are of academic interest.

 

 

To fulfil these objectives, we have positioned our self as an Academic Contract Research Organization (Academic CRO), and work closely with pharmaceutical and biotechnology companies. We also welcome opportunities to work with other CROs to ensure the quality of clinical trials data in our institution.

CCT possesses a number of unique characteristics as an Academic CRO, including:

• Employs personnel with a wide range of experience in designing clinical trials, analyzing results, and data management.
• Participates in clinical trials methodology research to enhance the efficiency and quality of trials.
• Operates a CCT workflow system using Microsoft Office SharePoint Server technology to maintain clear standard operating procedures (SOP) for both generic tasks as well as project-specific tasks, and to enhance communications with sponsors in project management.
• Developing an IT system to operate trials effectively, including a Web-based randomization and electronic case-report form.
• Possesses expertise in various aspects of training for clinical trials operations, including investigators training, research nurse training, clinical research associates training, biostatistics training, research ethics workshop, etc.
• Investigators in the institute have a strong peer network around the world, with particularly strong links in Southeast Asia and Mainland China.
• Senior members of various departments across a number of disciplines are opinion leaders and actively recruit patients for clinical trials.

Since its establishment, CCT has proven its ability to generate valuable clinical research data, and in the last three years has generated contracts worth more than $3.0 million for data management alone. The value of contracts for clinical trials is substantially higher. Working with both local and international pharmaceuticals and biotechnology companies of all sizes, our goal is to strengthen the clinical research base in Hong Kong, as well as across Asia.

Professor Benny Chung-Ying Zee
Director, Centre for Clinical Trials,
School of Public Health,
The Chinese University of Hong Kong