Managing subjective end points

Physician assessment of end points in clinical trials, including a number of recent large pivotal studies in the cardiovascular field, has stimulated differences of opinion about the best course for managing studies where the results are based on conclusions that are at least partially subjective.

In these studies, the design challenge is to keep end point assessment consistent across centers and investigators. But the solution is less obvious, as illustrated by the difference between opinions expressed in an FDA advisory committee's recent review of Merck & Co. Inc.'s Aggrastat tirofiban platelet inhibitor and the conclusions of Duke University researchers who have studied trials of several other cardiovascular agents...