New drug molecules may have a creative mechanism of action, but the fact that they work does not mean that they help. Improvement in function, feelings or survival is what patients expect from a medicine. This can only be determined in clinical trials. The cost of these trials has gone up to unsustainable levels. We may find ourselves with a surplus of interesting molecules that cannot be tested in trials. So, something has to change. The question is what. This is the subject of the opening debate.