February, 2003
© 2000, 2001 Scott S. Emerson, M.D., Ph.D.
Session 3: 67
Monitoring Secondary Endpoints
Statistical issues due to rare events (cont.)
The increased error rate of acting on such trends is a necessary evil
·Of some solace is the fact that most new treatments do not prove beneficial, so such conservatism is probably not too harmful in the quest for new treatments
·In essence, we decide to only look at the most safe treatments (and the trials that tended to result in the safest profile)