Singapore has been emerged as a regional hub for conducting biomedical science research and clinical trials. Skills and infrastructure in clinical trials must be further developed in order for Singapore to stay competitive globally. This course provides participants with the theoretical and practical foundation needed to design, conduct, analyze and interpret clinical trials. Participants will be exposed to different types of clinical trials employed in the industrial, government and academic sectors for pharmaceutical, medical device and biological interventions. The ethical and regulatory issues involved in conducting clinical trials will also be discussed as with the statistical tools for clinical investigations. This course is organized by UniSIM and Raffles Hospital and supported by Health Science Authority (HSA) and Tan Tock Seng Hospital.

Course Objectives

• To gain an overview of clinical trial types, phases, processes and parties involved
• To review the roles and responsibilities of the various parties involved in clinical trials
• To learn the essential features of clinical trial design, protocol write-up and project planning
• To know the regulatory issues and bodies concerned
• To identify the principles of good clinical practice
• To learn how to manage a clinical trial / investigation site and data collected
• To appreciate the basic statistical tools for analyzing clinical trials
• To learn about scientific writing and how to appraise scientific literature

A/Prof Adrian Yap, PhD, MSc, BDS, FAMS

Dr Yap is a Consultant and Prosthodontist at Raffles Hospital. He is also an Adjunct Associate Professor at SIM University (UniSIM) and the National University of Singapore (NUS). He obtained his PhD, BDS and Graduate Diploma in Psychotherapy from NUS and MSc (Conservative Dentistry) from the University of London. Dr Yap has been involved in clinical / laboratory research for many years and has authored more than 160 refereed journal articles, 360 conference/seminar papers as well as several book chapters. Dr Yap has received numerous clinical, research and teaching awards and serves on the editorial boards of several international journals.

Dr Ng Chee Keong, MBBS, MRCP, FACC, CBNC, FAMS

A graduate of NUS in 1991, Dr Ng is an Interventional Cardiologist at Raffles Hospital. He has participated in several international studies as primary investigator for Singapore research sites and was a member of a hospital Institution Review Board.

Mr Foo Yang Tong, BSc(Pharm)

Mr. Foo holds the appointment as the Acting Director of the Clinical Trials Branch in the Health Sciences Authority (HSA). He has been with the HSA for 8 years. In this role, he oversees management and professional activities of the Clinical Trials Branch in HSA, which has regulatory oversight of clinical trials on medicinal products in Singapore. After graduating from the National University of Singapore in 1992, he worked in a hospital as a pharmacist till 1998 when he joined the clinical research industry conducting local and regional clinical trials with a pharmaceutical company and later on with a contract research organization before joining the HSA.

Prof Brian Peacock, PhD

Dr Peacock has a PhD from the Birmingham University. He has worked for 18 years in Academia, 15 years at General Motors and 4 years at NSBRI / NASA. He specializes in Human Factors and Industrial Engineering. He has published extensively, including a book on Statistical Distribution. Apart from teaching graduate and undergraduate courses in statistics, for two years he was statistical advisor to the Royal College of General Practitioners.