February, 2003
© 2000, 2001, 2003 Scott S. Emerson, M.D., Ph.D.
Session 1- Overview: 40
Ethical Issues
Data safety monitoring committee (cont.)
Review of interim data
·DSMB is unblinded to treatment assignment
-Interim analyses results kept confidential
· Recommendations for early termination are often guided by formal stopping rules
-Recommendations are advisory to sponsor