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Title: The potential for a controlled human infection platform in Singapore
Authors: Balasingam, Shobana
Horby, Peter
Wilder-Smith, Annelies
Keywords: DRNTU::Science::Biological sciences
Issue Date: 2014
Source: Balasingam, S., Horby, P., & Wilder-Smith, A. (2014). The potential for a controlled human infection platform in Singapore. Singapore medical journal, 55(9), 456-461.
Series/Report no.: Singapore medical journal
Abstract: For over 100 years, controlled human infection (CHI) studies have been performed to advance the understanding of the pathogenesis, treatment and prevention of infectious diseases. This methodology has seen a resurgence, as it offers an efficient model for selecting the most promising agents for further development from available candidates. CHI studies are utilised to bridge safety and immunogenicity testing and phase II/III efficacy studies. However, as this platform is not currently utilised in Asia, opportunities to study therapeutics and vaccines for infections that are important in Asia are missed. This review examines the regulatory differences for CHI studies between countries and summarises other regulatory differences in clinical trials as a whole. We found that the regulations that would apply to CHI studies in Singapore closely mirror those in the United Kingdom, and conclude that the regulatory and ethical guidelines in Singapore are compatible with the conduct of CHI studies.
ISSN: 0037-5675
DOI: 10.11622/smedj.2014114
Schools: Lee Kong Chian School of Medicine (LKCMedicine) 
Rights: © 2014 Singapore Medical Association. This paper was published in Singapore Medical Journal and is made available as an electronic reprint (preprint) with permission of Singapore Medical Association. The paper can be found at the following official DOI: []. One print or electronic copy may be made for personal use only. Systematic or multiple reproduction, distribution to multiple locations via electronic or other means, duplication of any material in this paper for a fee or for commercial purposes, or modification of the content of the paper is prohibited and is subject to penalties under law.
Fulltext Permission: open
Fulltext Availability: With Fulltext
Appears in Collections:LKCMedicine Journal Articles

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