Originally posted by: ThePresence
Did they tell you about the possible side-effects? :Q
I don't think he has gotten that far yet. That is what the informed consent form is all about.
Just everyone knows, here are the 3 stages of human clinical drug trials:
Phase I Various dosages are tried on healthy males to develop a safety profile. It is males only because noone wants to find out too late that they just made all the females sterile... Keep in mind, that as dangerous as this sounds, it is for the most part very safe. Pre-clinical research has given them a good general safety profile, they are just collecting more data in the dosage range they hope to use therapeutically
Phase II Patients with the condition the drug is targeting are given the drug in order to find out what is the best dose level and just how effective the drug is.
Phase III Large scale trial with lots of patients so that a complete effectiveness and safety profile can be developed.
The results of all these trials are then presented to the FDA for review and (potential) approval.