3 ms·
I found it strange that the claim that "deaths in clinical trials are thought to be rare" was backed up with a study from Germany, since this involves the Unite
by notjulianjaynes 3y ago
I found it strange that the claim that "deaths in clinical trials are thought to be rare" was backed up with a study from Germany, since this involves the United States FDA.
After some non-expert searching I could not find a more relevant source either, possibly owing to a lack of "unambiguous and complete reporting of the number of deaths in trial registries and publications" [1].
A watchdog group's lawsuit against the FDA claims that from 2014-2017 there were 150 deaths related to clinical trials [2] but I am not certain how reliable that figure is.
[1] https://bmjopen.bmj.com/content/3/1/e001963 https://bmjopen.bmj.com/content/3/1/e001963
[2] https://www.clinicalleader.com/doc/clinical-trial-deaths-will-clearer-informed-consent-documents-be-enough-0001 https://www.clinicalleader.com/doc/clinical-trial-deaths-wil...