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Clinical Trials Office

Synonym(s):

Cancer is a major health problem worldwide. About 10 million people annually are diagnosed with this disease and 6 million are expected to succumb to it. In Singapore the crude cancer incidence rate is projected to rise for the next two decades as the baby boomers now reach the age when most cancers develop. Unfortunately, despite best efforts, we are l unable to find cure for 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 of the patients. These therapies are developed through clinical trials, which involve regulated and closely monitored processes of testing new drugs and drug combinations in patients, in order to evaluate and confirm their efficacy and safety. National Cancer Centre Singapore (NCCS) conducts clinical trials though the Clinical Trials Operations Department of the Humphrey Oei Institute of Cancer Research, that provides the infra-structural support for the conduct of all phases of clinical trials including interventions such as drugs, biologics, surgery and radiation therapy. , for the prevention, diagnosis and treatment of cancer.

Clinical Trials Operations

We have a team of dedicated, specialized staff to support investigators in the areas of trial co-ordination, budget and project planning, protocol development, negotiation of agreements, ethical and regulatory reporting and submissions, case report form design and data discrepancy management.

Research Experience

With more than 20 years of experience in conducting clinical trials to date, we have completed more than six hundred clinical trials. Of interest, are trials of the new small molecular targeted agents, vaccines, stem-cell mini-transplants and adoptive T cell therapies on the different cancer types such as breast, lung, nasopharynx, stomach, colorectum and liver cancers. In 2019, we initiated many multicentre investigator-initiated trials involving sites in the Asia-Pacific regions in which we are the lead coordinating site.

Our investigators are constantly in search of cutting edge methods and treatments and actively coming up with ideas and protocols for clinical testing. With the help of recent developments in technology, we are also moving towards decentralization in the form of convenient home based procedures to make trial participation convenient to trial participants so that they can continue with their day-to-day lives with minimal disruption. Our purpose of doing this is to improve and reduce trial participants’ burden and so, improve trial participant recruitment and retention.

We provide teleconsulting services, to save trial participants a trip to NCCS for every trial visit. Home based protocol care for trial participants is provided by qualified healthcare practitioners to perform tests, obtain biological samples for testing and to administer trial medications, as required for the trial for trial participant’s convenience.

Our Infrastructure

The New National Cancer Centre Singapore, operational since 2023, consists of a new 24-storey building that provides ample space for the conduct of clinical trials and for future expansion of trial services.

NCCS has been under the US Federal wide Assurance program from the US Health and Human Services for human subject protection for the past 21 years and will continue in this program. This certification allows NCCS to qualify for US Government supported research from CTEP of the US National Cancer Institute.

We have established a specialized study feasibility team that assists our potential collaborators , companies and academic institutions in conducting site feasibilities, including the review of confidential trial agreements. The feasibility team facilitates the activities of the NCCS Clinical Trials Steering Committee in the selection of clinical trials to be conducted by the centre, to ensure it meets patient needs. After NCCS is selected to participate in a trial, our highly trained clinical research coordinators will work with the companies and academic institutions to provide trial resource-related information to assist in pre-study preparation.

Our team of Clinical Research Co-ordinators (CRCs) are carefully selected to ensure that they have the aptitude, qualification, and interests suitable for the work. Our CRCs have at least a degree in nursing, life or health sciences and are required to undergo continuous rigorous of our in-house training as oncology trials are complicated.

Our CRCs work in teams and specialize in different tumor types such as breast, lung, gastrointestinal, urogenital, head & neck, lymph and blood cancers, and different trial types such as academic trials and phase 1 trials. Each team is supervised by 1-3 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 all trials. We have the facilities and well-crafted workflow to ensure that biological specimens for central laboratories are handled under protocol prescribed conditions and in compliance with local laws and regulations. Our inpatient early phase unit is housed in SingHealth Investigational Medicine Unit, a specialized unit for studies involving complicated procedures, intensive pharmacokinetic blood sampling and trials involving overnight monitoring.

We have dedicated Clinical Trial Pharmacists who reconstitutes and dispense trial drugs and provide drug counselling to our trial participants. The onco-pharmacy has the capacity and experience to provide home delivery services for oral study drugs to trial participants. NCCS has a large Ambulatory Treatment Unit that serves all NCCS patients including trial participants and the nurses of the Unit play an active role to ensure that the administration and handling of study drugs are performed according to the protocol.

We have a team of data managers, data coordinators and biostatisticians and they are experienced with the use of Redcap Data Management System to manage and store our study data for investigator-initiated trials. For industry sponsored trials, we have experience with a wide range of electronic data platforms.

Our Division of Radiation Oncology conducts radiation therapy trials and has collaboration with the Singapore General Hospital Department of Nuclear Medicine for trials involving radioactive materials. The Division also looks forward to conducting trials using its newly acquired PROTON therapy system.

Future Direction

Our aim is to continue to provide a centralised service for investigators and companies to conduct clinical trials and be a leading centre in clinical trial research. Our objective is to actively contribute to improving treatment of cancer while also providing patients with novel therapeutic options.

Selected Clinical Trials

Please click here for Selected Clinical Trials list.

 

HEAD: Prof Daniel TAN
​DIRECTOR, ADMINISTRATION & OPERATIONS: ​Sue TEE
DEPUTY DIRECTOR, CONTRACTS MANAGEMENT : ​Ai Lin LOW
​PRINCIPAL CRC:

Lishan LOW