• Shobana Balasingam, Peter Horby, and Annelies Wilder-Smith.
• Department of Microbiology, National University of Singapore, Centre for Life Sciences, 28 Medical Drive,Singapore 117456. micbsh@nus.edu.sg.
• Singap Med J. 2014 Sep 1; 55 (9): 456-61.

AbstractFor 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.

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