EM3 Robustness of External Control Arm: WHEN to Use Them

During the COVID-19 pandemic, many aspects of traditional clinical trials have been affected worldwide. Recruitment of patients and on-site visits have been challenging when not compromised. Many groups have turned to the possibility of replacing their randomized standard of care (SOC) arm with a real-world (RW) external control arm (ECA). Unlike randomized controlled trials (RCTs) that have international guidelines, the use of an ECA is not subject to any consensus.

Source: Value in Health - June 1, 2021 Category: International Medicine & Public Health Authors: M. Ladouceur, C. Colby, S. Okala, B. Yue Source Type: research