YouCanTeach an Old Dog New Tricks

Abstract

Clinical trials of a new treatment are undertaken in three phases. Phase I trials are designed to test the safety of the new treatment, phase II to test its efficacy, and phase III to compare it with standard treatment in a large number of patients selected to be as homogeneous as possible. The protocol is developed before the trial begins, and there are usually no changes in it, including entry criteria and end points, as the trial progresses. Thus, for good scientific reasons, clinical trials are designed to be rather formal and rigid.But all that is changing. In the . . .