Are Randomized Trials Appropriate for Evaluating New Operations?

A single operation, coronary-artery bypass, has gained unprecedented popularity despite lack of unequivocal evidence that it prolongs the life of most patients. This situation has evoked editorial pleas for prospective, randomized studies of the procedure,1 and, more recently, the suggestion that such studies be performed "from the very first clinical trial" of all new operations2 and precede widespread use not only of surgical procedures but of "costly procedures of all kinds."3 These proposals reflect how much we have profited from prospective, randomized studies of new drugs, but they do not fully recognize the differences between new drugs and new operations. . . .