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  • jnm22 replied to the topic Unexpected Clinical Study Results in the forum Clinical Trials for Medical Devices 7 years, 11 months ago

    My company had a study go on “pause” due to an unexpected side effect. The people enrolled were not administered anymore doses and others were prevented from joining until the problem was solved. An investigation was done and It had to do with a component of the drug and not the drug itself so it was switched tested and the study resumed. No one got in trouble as it was something you couldn’t foresee and it wasn’t a deadly side effect more of an uncomfortable one.