Gilead/Remdesivir Update: Politics & Methodology Issues Cloud Research

GileadRemdesivir Update Politics & Methodology Issues Cloud Research

As reported by StatNews on May 5, Gilead announced April 29th that remdesivir was found to speed recovery from COVID-19, but effectively changing the study hypotheses midstream leads to doubt about the results. Why, it was asked, did the study’s main goal change only weeks prior? StatNews notes that defining the “primary endpoint” is key. According to some wise people out there, this is analogous to declining to call a shot in pool—you may get credit, but for an accidentally sunk ball. And, “Changing a primary endpoint when you already know the data is even worse. It can even amount to outright research fraud. To mix sports metaphors, researchers often liken it to drawing a target around an arrow after you shot it, and then claiming a bull’s-eye.” 

In defense of the research, the NIAID said “the change was made while still blinded to all outcome data because agency statisticians had performed modeling showing that the original endpoint—an eight-point scale of how subjects were doing that ranged from dead (the worst outcome) to out of the hospital with no restriction on activities and no need for oxygen (the best) on the 15th day of the study—might not detect a difference where ...

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