Similarly, when I was doing my initial training to work at a clinical trial a few years agoone of the things I learned was that anything that results in hospitalisation or death is considered an 'Adverse Event'. Even if the patient was run over by a bus, that would be recorded as an AE and reviewed accordingly.
At the time, I thought that was a perfectly reasonable precautionary requirement for clinical trials - after all, if 90% of people receiving the Investigational Medicinal Product were run over by buses, but 0% of people receiving the placebo were run over by buses, that might indicate that the IMP makes you walk out in front of buses. Now, however, I realise that I should have just run out of the hospital screaming 'WAKE UP SHEEPLE' at the top of my lungs.
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Wed 27 Jan 2021, 13:51,
archived)
At the time, I thought that was a perfectly reasonable precautionary requirement for clinical trials - after all, if 90% of people receiving the Investigational Medicinal Product were run over by buses, but 0% of people receiving the placebo were run over by buses, that might indicate that the IMP makes you walk out in front of buses. Now, however, I realise that I should have just run out of the hospital screaming 'WAKE UP SHEEPLE' at the top of my lungs.