![]() ![]() The new paper is about the NIH's TOPCAT trial, which in 2014 concluded that spironolactone (Aldactone) did not improve clinical outcomes in heart failure patients with preserved ejection fraction. I'll just say that globalization of trials is much needed since 96% of people don't live in the U.S., but 'offshoring' for financial reasons is bad because it raises the risk of malfeasance." Noted skeptic John Ioannidis (Stanford University) went further, saying that the finding "opens a can of worms on how much we can trust clinical evidence from these settings." Former FDA commissioner Rob Califf said the finding "is disturbing and it's good to get it published. The new paper provoked expressions of concerns from not only well-known skeptics but also those deeply committed to clinical research. ![]()
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