The potential for a controlled human infection platform in Singapore
Singapore medical journal
;
: 456-461, 2014.
Artigo
em Inglês
| WPRIM
| ID: wpr-274205
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.
Texto completo:
DisponíveL
Índice:
WPRIM (Pacífico Ocidental)
Assunto principal:
Ásia
/
Padrões de Referência
/
Projetos de Pesquisa
/
Singapura
/
Quarentena
/
Controle de Doenças Transmissíveis
/
Epidemiologia
/
Doenças Transmissíveis
/
Ensaios Clínicos como Assunto
/
Análise Custo-Benefício
Tipo de estudo:
Guia de Prática Clínica
/
Avaliação Econômica em Saúde
/
Estudo prognóstico
Limite:
Humanos
País/Região como assunto:
Ásia
/
Europa
Idioma:
Inglês
Revista:
Singapore medical journal
Ano de publicação:
2014
Tipo de documento:
Artigo
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