The COVID-19 pandemic had a profound impact on the conduction of clinical trials. Trials had to adapt to social distancing and quarantine measures which may potentially influence trial outcomes with increasing likelihood of trial dropout. Here, we discuss our clinical trial experience involving a novel monoclonal antibody with a controlled human malaria infection model, and the actions that were taken in order to achieve our study objectives.
Learning Objectives:
Increase awareness of the controlled infection model approach to infectious disease interventions.
Increase awareness on how controlled infection model data is used to move drug development forward.
Expand the discussion of impact on combination safety/efficacy study designs for diseases of global public health.
