Cancer is a major health problem worldwide. About 10 million people annually are diagnosed with this disease and 6 million are expected to die from it. In Singapore the crude cancer incidence rate is expected to rise for the next two decades as the baby boomers now reach the age when most cancers develop. Unfortunately, despite the best efforts, we are still unable to cure most patients with recurrent cancer. Hence, search for new therapies, is critical for the cure of cancer, for the prolongation and the improvement of quality of life. These therapies are developed through clinical trials, which involve regulated and closely-monitored processes of testing new drugs and drug combinations in humans, so as to evaluate and confirm their efficacy and safety. The Clinical Trials Office of the Humphrey Oei Institute of Cancer Research provides the infra-structural support for the conduct of all phases of clinical trials at the National Cancer Centre Singapore.
We have a team of dedicated staff to support investigators in the areas such as trial co-ordination, budget and project planning, protocol development, negotiation of agreements, ethical and regulatory submissions, case report form design and data discrepancy management.
We have more than 20 years of experience in conducting clinical trials and to date, have completed about 280 clinical trials. Currently we have about 200 ongoing trials. Of particular interests are trials of the new small molecular targeted agents, vaccines, stem-cell mini-transplants and adoptive T cell therapies on the different cancers types such as breast, lung, nasopharynx, stomach, colorectum and liver cancers. Our investigators are constantly in search of new methods and treatments, and actively coming up with new ideas and protocols for clinical testing.
The National Cancer Centre Singapore has obtained Federalwide Assurance from the United States Department of Health and Human Services for human subject protection. This certification allows NCCS to qualify for US Government supported research from CTEP of the US National Cancer Institute.
We have established a study feasibility team that assists the industries and academic institutions in conducting site feasibilities, including review of confidential agreements. The feasibility team facilitates the activities of the NCCS Clinical Trials Steering Committee in selection of clinical trials to be conducted by the centre.
Our research co-ordinators (CRCs) are stringently selected to ensure that they have the aptitude, qualification and interests suitable for the work. Most of our coordinators have at least a degree in medicine, nursing, life or health sciences and have to undergo continuous rigorous training under strict supervision.
Our CRCs worked in teams. The teams specializes in different tumor types. Each team is supervised by 1-2 dedicated team leaders who have the experience and extensive knowledge in clinical trial supervision and training.
We are well equipped to carry out routine trial procedures for Phase 1 to Phase IV trials. We have the facilities and knowledge to ensure that biological specimens for central laboratories are handled carefully under protocol prescribed conditions. NCCS also has a GMP laboratory for preparing some of our biological agents.
We have dedicated Clinical Trial Pharmacists. The Ambulatory Care Unit nurses play an active role as part of the study team to ensure that the administration and handling of study drugs are performed according to the protocol. We are involved in research areas such as DCE-CT and DCE-MRI. PET and SPECT are available in the campus, and the Nuclear Medicine Department has its own in-house radio-chemist. We also partner with the SingHealth Investigational Medicine Unit, which has a 30-bed inpatient unit for early phase trials. We work closely with the unit for studies involving intensive pharmacokinetic blood sampling and subject overnight monitoring.
We use the Redcap Data Management System to manage our study data. Our team include data managers, data coordinators and statisticians.
We aim to continue to provide a centralised service for investigators and industries to conduct clinical trials and be a leading centre in clinical trial research. We aim to actively contribute to improving treatment of cancer while also providing patients with novel therapeutic options.
here for Selected Clinical Trials list.
Valencia A SHAH
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