February, 2003
© 2000, 2001 Scott S. Emerson, M.D., Ph.D.
Presentation of
results to the DSMB
Generally
avoid providing any P values or RCI for specific analyses to avoid their
difficult interpretation
·Have to
account for multiple comparisons across endpoints
·Have to
consider tradeoffs between efficacy and toxicity
·Statistical
significance may be secondary to safety concerns-- may need
to act before statistical significance is attained