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  • Luisa Gutierrez replied to the topic Consent and predicted outcome in the forum Clinical Trials for Medical Devices 7 years, 11 months ago

    Both of the cases provided above are great representation of a clinical trial going wrong. Companies before reaching the clinical trial stage, they make sure the pre-clinical trials are successful and the device is effective. Also, the company makes sure to allocate enough budget just in case the unexpected results occur and is able to compensate the patients accordingly. This is not the goal of course but it is something that needs to be planned. In addition, there are instances that even during the clinical trials there are no unexpected results but once the product reaches the market, the side effects start to surface. This can be due to having a larger population than from the clinical trials and the issues have a greater chance to occur.