Clinical Trial Coordination: Belinda WOON, Brighitte Ann VERZOLA, Ko Chun YANG, Ember CHIANG, Emily LIM, Geneviere HON, Jia NING, Julia TOH, San
Wei KHAING, Wen Ya KHOO, Liz ZHONG, Li Shan LOW, Madeline NG, Ma Elnora Vencer GALOR, Maria Carlotta FIGUEROA, Michellore DANNUG, Su Mon MYAT, Yin Yin Pyone NANG, Noryati ABDUL RAHMAN, Ru Yi ONG, Ruth KHOO, Sharleen CARREON, Sharon CHEN, Valencia Agnes SHAH, Lan Ying WANG, Mung Peng WONG, Shi Shin YANG, Sook Kuan YEO, Zay Yar MYINT.
Selected Publications
Wee J, Tan EH, Tai BC, Wong HB, Leong SS, Tan T, Chua ET, Yang ETL, Lee KM, Fong KW, Khoo-Tan HS, Lee KS, Loong S, Sethi VJ, Chua EJ, Machin D
Randomised phase III trial of radiotherapy versus concurrent chemo-radiotherapy followed by adjuvant chemotherapy in patients with AJCC/UICC (1997) stage III and IV nasopharyngeal cancer of the endemic variety. J. Clin. Oncol. (2005) 23(27):6730-6738.
Tan EH, Szcesna A, Krzakowski M, Macha HN, Gatzemeier U, Mattson K, Wernli M, Reiterer P, Hui R, Von Pawel J, Bertetto O, Pouget JC, Burillon JP, Parlier Y, Abratt R
Randomised study of vinorelbine-gemcitabine versus vinorelbine-carboplatin in patients with advanced non-small cell lung cancer. Lung Cancer (2005) 49(2):233-240.
Soo KC, Tan EH, Wee J Lim D, Tai BC, Khoo M, Goh C, Leong SS, Tan T, Fong KW, Lu P, See A, Machin D. Surgery and adjuvant radiotherapy vs concurrent chemoradiotherapy
in stage III/IV nonmetastatic squamous cell head and neck cancer: a randomised comparison. Br. J. Cancer (2005) 93(3):279-286.
Shepherd FA, Pereira JR, Ciuleanu T, Tan EH, Hirsh V, Thongprasert S, Campos D, Maoleekoonpiroj S, Smylie M, Martins R, Sukin M, Van Kooten M, Dediu M, Findlay B, Tu Donsheng, Johnston D, Bezjak A, Clark G, Santabarbara P, Seymour L A randomised phase III trial of erlotinib (Tarceva, OSI774) as second line or third line treatment following chemotherapy in patients with advanced non-small cell lung cancer. A trial of the National Cancer Institute of Canada Clinical Trials Group. New Eng. J. Med. (2005) 353:123-132.
Leong SS, Wee J, Tay MH, Toh CK, Tan SB, Thng CH, Foo KF, Lim WT, Tan T, Tan EH
Paclitaxel, gemcitabine, and carboplatin in metastatic nasopharyngeal carcinoma: a phase II trial using triplet combination. Cancer (2005) 103:569–575.
Cancer is a major disease worldwide. About 10 million people per year are diagnosed with the disease and 6 million die from it annually. Unfortunately, despite the best efforts, we are still unable to cure most patients with recurrent cancer. Hence, the search for new therapies is critical for the cure of cancer, and 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 efficacy and safety. The Clinical Trials Office provides the infra-structural support for the conduct of all phases of clinical trials at the National Cancer Centre Singapore (NCCS).
We have a team of dedicated clinical research coordinators to support
investigators in areas such as budget and project planning, protocol
development, negotiation of agreements, ethical and regulatory submissions,
trial coordination, case report form design and data discrepancy management.
Research Experience
We have more than 14 years of experience in conducting clinical trials, and have completed more than 70 clinical trials involving close to 1,500 subjects in total. In addition, we have about 60 ongoing trials. Of particular interest, are trials using new synthetic drugs, vaccines and stem-cell mini-transplants on different cancers such as the breast, lung, nasopharynx, stomach, colorectum, liver and lymphomas. Our investigators have set aside time to run clinic sessions just for trial visits, in order to give ample time and attention to our trial subjects.
Our Infrastructure
The NCCS has always supported its Institutional Review Board’s (IRB) commitment to protect human research subjects. Our IRB has obtained certification from the US Department of Health and Human Services in its Federal wide Assurance Programme for Human Subject Protection. This also qualifies the institution to perform US government supported research from the US National Cancer Institute.
Our research coordinators are stringently selected to ensure that they have the
aptitude, qualification and interests suitable for the work. Most of the
coordinators are holders of a bachelors’ degree in medicine, nursing or the life / health sciences. The coordinators assist the investigators in logistical and administrative tasks, in study initiation, patient recruitment, trial conduct and data collection.
NCCS has a modern IT infrastructure such as ISOFT which provides results of patients’ investigations; OAS for patients’ appointments / hospital stay and PACS for radio diagnostic images. We are also able to ensure that biological specimens for central laboratories are processed under the protocol prescribed conditions.
We work very closely with various other departments at the NCCS, such as the Pharmacy, Ambulatory Care Unit, Oncologic Imaging and the Pathology Laboratory at the Singapore General Hospital.
Our trial drugs are stored in optimal conditions in the pharmacy. Dispensing, reconstitution and drug accountability are performed by registered oncology 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 protocol.
The Department of Oncologic Imaging ensures that imaging requirements for trials are met and their radiologists provide image consultation service for trials upon request. We use the services of the Singapore General Hospital’s Pathology Laboratory, which is accredited by The College of American Pathologists; the Joint Commission International and certified by TÜV SÜD PSB Certification Pte Ltd.
We have recently upgraded our Oracle Clinical data management system (for investigator initiated clinical trials) to manage data more efficiently so that accurate and ‘clean’ data can be extracted for statistical analysis.
We have specific Standard Operating Procedures to help us achieve consistency in our clinical trials management processes, particularly in areas such as patient subject randomisation, blood processing and delivery, data management, ethics and regulatory requirements, safety reporting, other trial procedures and financial management.
Future Direction
We aim to continue to act as the central liaison and to provide a centralised service in trial negotiation and conduct for the NCCS. We will continue to provide strong support to our doctors for both industry and investigator-initiated trials.
