Utilizing a Registry to Inform an External Control Arm

A case study in drug-induced liver injury

Missy Vadnais | William Slone | Sarah Kavanagh

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.

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