Managing Human Challenge Trials: A Case Study

Volunteer Infection Studies (VIS) or Controlled Human Infection Models (CHIM) are an extremely effective way to gather early clinical evidence on efficacy, minimize potential risks, and maximize the outcomes when progressing a new drug or vaccine onto critical clinical studies. Their success relies on careful preparation by an experienced team that is capable of adequately managing the risks associated with the study.

In this bulletin, we will share firsthand management experience from a recently completed malaria human challenge trial conducted by the SGS Clinical Pharmacology Unit in Belgium. We will focus on the main operational challenges encountered by the study team during the preparation and the strategies implemented to overcome them.