Human Challenge Trials (HCT) or Human Infection Models (HIM) are an extremely effective way of validating treatment efficacy using real-world symptomology studies. The challenge of infectious agents with vaccine (or drug) in vivo offers early access to mode of action (MOA) and proof of concept (POC) data prior to designing later, larger phase field trials. The last two decades have seen a surge in antimalarial drug development with product development partnerships taking a leading role. The development of resistance to the past and present anti-malarial drugs highlights the need for continued research to stay one step ahead. New drugs are needed, particularly those with new mechanisms of action. Malaria Volunteer Infection Studies (VIS) serve as a valuable tool in antimalarial drug development. Both for prophylactic and curative treatment, models have been developed in clinical trials by injection of infected red blood cells or direct inoculation with malaria sporozoites. Pioneer trials have already been performed in different countries such as Australia and the Netherlands. Last year, the first malaria-VIS trial has been performed in Belgium, aiming to investigate a prophylactic treatment. A second VIS-trial testing a curative treatment model will start in March 2020. This workshop offers unique insights about Belgium’s pioneer malaria-VIS trials from the scientific community, the sponsor’s and the investigator’s perspective.
Digital transformation of a research site is a complex, resource-intensive, and lengthy undertaking with many challenges, that can cover the entire process of clinical research allowing data to be used much more effectively and efficiently for patient-centered research.