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Clinical Trials Operations

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 patients so as to evaluate and confirm their efficacy and safety. The Clinical Trials Operations of the Humphrey Oei Institute of Cancer Research provides the infra-structural support for the conduct of all phases of clinical trials including interventions such as drugs, biologics, surgery and radiation therapy at the National Cancer Centre Singapore, for the prevention, diagnosis and treatment of cancer.

Clinical Trials Operations

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 reporting and submissions, case report form design and data discrepancy management.

Research Experience

We have more than 20 years of experience in conducting clinical trials and to date, have completed more than five hundred clinical 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. In 2019, we initiated many multicentre investigator-initiated trials involving sites in the Asia-Pacific regions in which we are the coordinating site.

Our investigators are constantly in search of new methods and treatments, and actively coming up with new 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 on and reduce trial participants’ burden and so, improve subject recruitment and retention.

We provide teleconsult services so that subjects do not have to come to the site for every trial visit. We have also started home based protocol care to provide qualified healthcare practitioners to attend to trial participants in their homes to perform tests, obtain biological samples for testing and to administer trial medications, as required for the trial.

Our Infrastructure

The New National Cancer Centre Singapore consists of a new 24-storey building that provides ample space for the conduct of clinical trials and for future expansion of trial services. The Clinical Trials Operation has a new Clinical Trial Facility (CTF) that is dedicated for the conduct of trials. The unit is well-equipped with five treatment chairs, three treatment beds, procedure rooms, pharmacy and ambulatory treatment units for the convenience and closer monitoring of trial participants.

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 the industries 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 in house training as oncology trials are complicated.

Our CRCs work in teams and the teams 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 knowledge 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 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

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.

Selected Clinical Trials

Please click here for Selected Clinical Trials list.

HEAD:A/Prof Daniel TAN

Lishan LOW