Optimising Decision Making CHIM or Human Challenge Testing (HCT) is an increasingly recommended route to obtaining proof of concept data relating to the efficacy of anti-virals and vaccines during early phase development. While statistically meaningful data can be obtained in animal models, such models are inherently unreliable predictors for efficacy in humans due to the absence of prior exposure and thus pre-existing immunity and most animal species demonstrate substantial anatomical and immunological dissimilarities. The use of highly adapted laboratory strains in animal models is a complicated and time-consuming Due to their exploratory nature, objectives in CHIM studies can be adapted to aid data needed for design of later field trials.
process without the guarantee that it will be a reliable predictor. CHIM can give meaningful performance data based on PK/PD and safety assessments leading to faster Go/No-Go decisions.
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