As the lecture focused heavily on the consent portion, and addresses that clinical trail cannot take place if it is known before time that death is a possible outcome. This had me wondering, how can you possibly predict that before hand? Isn’t there always a margin or error in animal studies vs. human studies. They don’t necessarily have the give the same result. For example, have there ever been cases where extensive animal studies gave continuous expected results but when human trials began the results were unexpected.

What would be the outcome if a human subject suffers unexpected results? Where does this lead the project or the company responsible for approving clinical trials?