[Updated] –Trial leaders say they need to get down into the weeds of trial details. Large international trials are under fire. In recent weeks, as I’ve reported, serious questions have been raised about three major heart failure trials. There is no reason to believe these are the only trials about which questions will be raised…
As Another Trial Goes Bust Investigators Call For Major Changes In International Trials
April 29, 2017 by 2 Comments
–Why were so many ineligible patients in Eastern Europe enrolled in TRUE-AHF? A new analysis of the recent TRUE-AHF trial offers strong evidence that large numbers of patients from Eastern Europe were ineligible for the trial and should not have been enrolled. The analysis doesn’t change the main finding of the trial, but it does…
Serious Questions Raised About Integrity Of International Trials
April 26, 2017 by 4 Comments
–TOPCAT analysis is the ‘smoking gun’ for trouble from ‘offshoring’ trials. Large international randomized controlled trials, the cornerstone of modern medicine, are in big trouble. As clinical trials have become a global enterprise, many observers have become increasingly worried about the integrity of data from certain geographic areas, in particular from Russia and other countries…
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