Current Status of Clinical Trials and Good Clinical Practice in Singapore and Hong Kong
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Drug Informarion Journal. Vol. 31. pp. 1105-1108, 1997 F’rinted in the USA. All rights reserved.
CURRENT STATUS OF CLINICAL TRIALS AND GOOD CLINICAL PRACTICE IN SINGAPORE AND HONG KONG ROBERTTEOH,MD, FRCP General Manager, Quintiles East Asia Re Ltd., Singapore Science Park,Singapore
The Republic of Singapore and Hong Kong are discussed together because of the clear similarities in the population, per capita gross national product, disease patterns, medical practice, and regulatory requirementsfor clinical trials. A major difference is highlighted and that is the role of the Singaporian government, whose expressed aim is to establish Singapore as a viable coordinating hub for drug development in the region. The steps to realize this objective by building the necessary infrastructure are outlined. Finally, difficulties and issues encountered in running clinical drug trials to good clinical practice (GCP) guidelines are described with the aim that sharing such experiences will assist others in the implementation of GCP in East Asia. Key Words: Clinical trials; Singapore; Hong Kong; Good clinical practice
SIMILARITIES BETWEEN HONG KONG AND SINGAPORE THE DEMOGRAPHICS OF Hong Kong and Singapore are similar (Table 1) with respect to life expectancy, infant mortality, per capita GNP, and the number of doctors and hospital beds. Medical practice and training are virtually identical. Moreover, the diseases and medical conditions which have attracted multinational pharmaceutical firms to perform clinical drug trials in Singapore and Hong Kong are also similar. These include chronic hepatitis B, hypertension and vascular disease (stroke and myocardial infarction), hepatoma, and nasopharyngeal carcinoma, of which all have a high prevalence and incidence in Singapore and Hong Kong.
Presented at the DIA Workshop “Clinical Trials and GCP in East Asia,” July 7, 1996, Tokyo, Japan. Reprint address: Robert Teoh. MD, FRCP, General Manager, Quintiles East Asia Pte Ltd., 89 Science Park Drive #03-10/12. The Rutherford, Singapore Science Park, Singapore 118261.
Thus, clinical studies in these conditions have rapid patient accrual rates and there is a sound medical infrastructure which ensures that the data are high quality and consistent. Evidence that quality clinical studies are carried out to the highest standards in Hong Kong and Singapore is as follows. Currently, a Singapore site is part of a multinational, multicenter study to gather pivotal data for submission to the United States Food and Drug Administration (FDA) as part of a new drug application (NDA). A multicenter Hong Kong study in stroke has proven to be a seminal finding and the results have since been published in the New England Journal of Medicine.
GOOD CLINICAL PRACTICE IN SINGAPORE AND HONG KONG It is worth restating that however sound the data derived from clinical studies, they can only be usable for worldwide registration of the drug if they are acceptable to international registration authorities such as the
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