Abstract
Any new therapeutic advance requires clear proof of effectiveness from well-designed and well-conducted clinical trials that establish both the range of anticipated benefits and the potential adverse effects. However, for the results of clinical trials to be translated into clinical practice, physicians must be comfortable with their decisions to initiate and continue a new therapy in individual cases. Unlike clinical investigators, whose use of a new therapy is sheltered by protocol-based inclusion and exclusion criteria, titration regimens, and data and safety monitoring committees, the actions of treating physicians are more exposed. The assessment of whether a specific therapy will help . . .