Current Edition

Human Challenge Studies: An Effective Tool for Drug Development

Human challenge studies (HCS) were introduced as an
alternative to community clinical trials for anti-infective
agents and vaccines, previously performed in regional clinics
and hospitals. In an HCS, subjects may either be inoculated
with a candidate vaccine before being exposed to a live
challenge virus, or dosed with an investigative therapeutic
agent following experimental infection. In this article, Adrian
Wildfire, SGS Infectious Diseases project director, outlines
the advantages of human challenge studies.