You just elaborated on the concept of the goal of clinical trials and the approval process which is summed up in "do the benefits outway the risks?" Adequate sample size, are the majority of patients better off?...quality of life? Will the patient benefit versus the placebo?
This is a very thorough law but the end goal is to see if the product benefits will outway the risk.
Is it a difficult process for approval? Yes? Is it impossible? No
I can't even believe we are debating this here. All of this should be logical.
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