Gilead’s RWD comparison for remdesivir is ‘not in the same league of evidence’ as controlled studies, says Bach

As real-world data continue to take on a more prominent role in clinical development, Gilead’s comparison of severe COVID-19 patients in a clinical trial of remdesivir versus a real-world cohort raises questions of how and when to it.

Gilead Sciences Inc. (NASDAQ:GILD) reported Friday that the mortality rate in its Phase III SIMPLE-Severe study of remdesivir was 7.6% vs. 12.5% in 818 patients from a RWD cohort receiving standard-of-care (SOC) treatment (odds ratio=0.38, 95% CI: 0.22, 0.68, p=0.001)...