The Clinical Trial Unit has been supporting cancer trials at NCIS for 15 years. The unit comprises a Clinical Trial Director, 2 administrators, a finance officer, 12 study co-ordinators, 5 research nurses, and a quality control officer. We are widely networked with industry, receive 120-150 feasibility requests for industry-sponsored clinical trials annually, and conduct up to 60 therapeutic trials at any one time. Our administrators handle protocol submissions to ethics and regulatory authorities, negotiation of study budget, and handling of clinical trial agreements. All our study co-ordinators are trained in Good Clinical Practice, and several senior co-ordinators are accredited by the United States Society of Clinical Research Associates. We have standard operating procedures and internal audit processes to ensure high standards of study execution and data consistency; we undergo regular external audits by industry partners and regulatory authorities, and enjoy a wide reputation of being a unit with high standards.
Clinical Pharmacology and Experimental Therapeutics (CEPT) Core was established in NUS by A/Prof Goh Boon Cher in 2000. It has progressed to become a state-of-the-art platform for preclinical and clinical pharmacokinetics studies and drug analysis, which is one of the core research tools in drug discovery pipeline and personalized medicine. Currently, CEPT core is equipped with API 3200 LC-MS/MS, API 4000 LC-MS/MS and an Agilent HPLC-UV/FL system coupled with 1200 fraction collector. With a multi-disciplinary team made up of clinical pharmacologists, analytical chemists and PK/PD modeling scientists, CEPT has the capability to support preclinical and clinical studies through the analysis of drugs in body fluids and tissue samples along with modeling of pharmacokinetics with pharmacodynamics and pharmacogenetics to optimize therapeutic efficacy and minimize drug toxicities in patients. In addition, various studies can be designed for in vitro characterization of drug-drug interactions and drug metabolism.
The Cancer Genomic Core serves to assist investigators from the Research Themes within the NCIS Centre Grant in cancer discovery work with the goal to prognosticate the severity of the patients’ disease, predict the best therapies for the cancers, predict the response to therapy and identify tumor genomic changes at relapse to help explain acquired drug resistance. This Core is located within the Cancer Science Institute, and comprises state of the art technology platforms and a team of specialized scientists with the technical and intellectual ability to achieve the above goals through studies using immunohistochemistry, Fluorescent in situ hybridization (FISH), RNA or miR expression analysis, whole-genome/exome sequencing and SNP-array. Most importantly, our bioinformatics team, armed with all the required software, can comprehensively analyze the data to provide an overview of the tumor’s genomic landscape, in concert with a vast array of patient data gained from in-silico databases. In summary, this Core will develop a common genomic databank to facilitate data sharing by the thematic groups, allowing them to focus on successful clinical investigations.
While the understanding of cancer genomics have lead to the development of a number of targeted therapeutic agents that have reach the clinic, resistance can emerge and is a therapeutic challenge. In most situations, the eventual route to refractory disease is drug resistance. It is therefore of great clinical importance that we have a good framework and platform to systematically study drug resistance in cancer. This core is composed of a team of translation scientist that have expertise in generating drug resistance cell lines, molecular biology and gene manipulation as well as animal models, and bioinformaticians and computational biologists with expertise in database integration, gene expression analysis and cross platform iterative interrogation. Our core will therefore provide the technical and analytical expertise to help the clinical teams gain insight into resistance mechanisms relevant to their drugs of interest.
The NUHS Tissue Repository (TR) together with the Hospital-based Cancer Registry (HCR) serves to provide researchers with high quality clinical samples and data. TR has a purpose-built laboratory for specimen processing and multi-site storage facilities, which includes mechanical freezers and liquid nitrogen vapour phase storage. TR collects all types of solid tissue samples, blood and bodily fluids. The TR follows the “ISBER Best Practices” and will also be going for the CAP accreditation 2014/2015. The HCR collects detailed information on every cancer patient treated at NCIS and maintains links with the National Registry of Diseases Office. The HCR follows the datasets and standards of practice set by the American College of Surgeons Commission on Cancer and the North American Association of Central Cancer Registries with more than a hundred data elements ranging from patient identification, cancer identification, stage of disease at diagnosis, first course of treatment, outcomes and follow up treatment.
The Cancer Epidemiology and Statistics (CES) Core is led by Associate Professor Mikael Hartman. The goals of the Core are to: assist with descriptive and etiological characterization of refractory cancers affecting Singaporeans and the South East Asian community, facilitate the study of mechanisms of treatment resistance and their effects on outcomes, and assess the added value of new diagnostic and prognostic markers in the clinical setting for patients with refractory cancers. The CES Core aims to bridge all six Research Themes under NCIS, and provide a strong foundation to clinical cancer epidemiology. The Cancer Epidemiology and Statistics (CES) Core has established skills in study design (clinical trials, hospital and population-based), clinical epidemiology (assessment of diagnostic and prognostic factors) and statistical analysis that enables the Core to extend its expertise into the NCIS various Research Themes. The Core has a strong focus in cancer genomics and statistical genetics, and a strong synergy exists between the Core and the Genomics program at the Saw Swee Hock School of Public Health (SSHSPH).
The Developmental Imaging Core has the goal of integrating imaging research at the A*Star/NUS Clinical Imaging Research Centre (CIRC) with clinical cancer research at NCIS and NUS. The primary role of CIRC is to undertake research in advanced clinical imaging. Imaging facilities at CIRC include two 3-T magnetic resonance imaging (MRI) scanners, a positron emission tomography-MRI (PET-MR) system and a PET/CT system. Additionally, a radiochemistry suite and cyclotron are being commissioned that will enable in-house production of novel PET tracers. The comprehensive CIRC team includes MRI and PET physicists, image analysts, radiochemists and radiographers. We expect that this core will complement the clinical trials and biomarker-driven therapeutics research cores by providing excellent in-vivo imaging. The proposed budget for this core is meant to supplement existing funding for CIRC and NCIS, particularly for pilot studies with scientific merit.