Utilizing a Registry to Inform an External Control Arm
A case study in drug-induced liver injury
Clinical trials that rely on external data sources to provide a control arm pose an attractive alternative to an internally administered control group. In principle, they give study participants a higher likelihood of exposure to the developmental therapy, which is a particularly desirable proposition when the disease in question has high morbidity or mortality. This whitepaper explores the utility of registry data applied as an external control arm, providing a step-by-step description of the process in a real-life study.