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asimbana replied to the topic Consent and predicted outcome in the forum Clinical Trials for Medical Devices 7 years ago
As the previous commentator mentioned previously, it is difficult to predict adverse effects of a product using collected data from pre-clinical trials. Indeed, pre-clinical trials holds value but it can only be represented to a certain point before reaching into the “grey area” in terms of the product having human risk. Previously mentioned, companies attempt to ensure that clinical trials are conducted successfully but even so, it was seen by previous cases that human risk is still present. Companies try to forecast this potential risk when testing new products, a budget is set aside to compensate the affected patients, indeed the informed consent does cover the company legally to a certain degree. This would explain why companies always must disclose any side-affects once a drug is passed and released, because there is always a risk in any drug.