Human Challenge Studies: Their conduct and safety aspect

If there would be a survey of 100 clinical research professionals either from CRO or from Pharma/Biotech industry to explain what a human challenge study is, the most common answer most probably would be – “I have never heard of it” and only very few of them would give the correct description. This is not something extraordinary, as this type of clinical studies is unique and niche, and highly therapeutically focused. A different situation in responses would be if the respondents of such survey would be those working in the field of infectious diseases or early clinical development of vaccines.

Even though human challenge studies or controlled human infection model (CHIM) studies may sound like something new within the clinical research space, over the past 80 years they have been conducted for over 20 different infectious disease pathogens and over 45,000 volunteers have participated in these clinical trials (1,2). Over 200 CHIM studies have been registered on clinicaltrials.gov. 

hVIVO plc (formerly Open Orphan plc) is a rapidly growing specialist contract research organisation (CRO) and the world leader in testing infectious and respiratory disease vaccines and antivirals using human challenge clinical trials, providing end-to-end early clinical development services for its broad and long-standing client base of biopharma companies.

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