As a general rule, the pre-market review reveals the most common ADRs.
Normally, between 2,000 and 3,000 patients will have tried the drug before it is marketed, although, of course, it all depends on the type of drug. In light of the number of patients who participate in trials, it is clear that we endeavour to strike a balance between getting the drug onto the market and having adequate knowledge of it. Obviously, asking manufacturers to test the drug on a larger number of patients will delay its introduction to the market. Nonetheless, in some cases, I think that is what needs to be done. In spite of pressure brought to bear by manufacturers for financial reasons, in some cases, that is indeed what needs to be done. As I said earlier, however, in other cases, depending on the type of disease, or whether the drug constitutes a therapeutic breakthrough, or whether the patients have no other options available to them, it is sometimes preferable to accept a greater degree of risk. I think that is important to assess the risks and the benefits, and to take stock of what constitutes acceptable risks in a given situation. I do not, therefore, believe that it is appropriate to use the same approach in all cases.