February, 2003
© 2000, 2001  Scott S. Emerson, M.D., Ph.D.
Session 2: 8
Need for Monitoring a Trial
Futility considerations: Efficiency and Ethics
Efficiency
·Stop a study when it is known (or reasonably certain) that no effect will be demonstrated
·Can perform more studies with limited resources
Ethics
·Is it ever ethical to expose patients to experimental treatments when no meaningful information will be gained?
·Can devote resources to study of more promising agents