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hm243 replied to the topic Unexpected Clinical Study Results in the forum Clinical Trials for Medical Devices 7 years ago
A major reason as to why a clinical study may be stopped would be due to a side effect that was not expected. If one of the participants in the study ends up having a side effect, especially one that is life threatening, the study will be shut down to prevent from putting more lives at risk. If there is only a slight side effect, but it occurs in most of the participants, then it is also likely for the study to be shut down as to determine what is causing the side effect. Although the clinical study would be shut down for these factors, there would not be a specific person held responsible. Certain side effects cannot be determined in advance until the product is test for use as needed. As a result, this would just be an issue with the product that will need to be fixed and then retested. Stopping a study does cause a delay in the process, but it is better to determine possible risks early on then releasing something that could cause harm that should have been tested for.