Originally posted by bjl584
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The public is just suddenly seeing the typical everyday process of pharmaceutical R&D. This is completely normal stuff. I've never done vaccine trials but I have been involved in clinical trials for other medications. There is a rigorous tracking and reporting process for identifying and evaluating any adverse events. Any time something happens, the primary question is always, "Was the adverse event related to the trial agent?"
Just because you are a patient in a clinical trial, it doesn't mean that everything that happens to you is due to the experimental drug - but that needs to be determined each and every time. If you develop a sore throat, was it because of the study drug? If you get a bruise on your arm, was it because of the study drug? If your ankles swell up, was it because of the drug? Or was your sore throat because your kid came home from school with Strep and gave it to you? Was that bruise because you whacked your arm while cleaning your garage? Did your ankles swell because you forgot to take your diuretic for a few days?
Pausing a study when something unexpected happens is exactly what should occur. The incident gets investigated. Once they determine the cause, they resume the trial unless it's found that the study drug caused the problem.
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