February, 2003
© 2000, 2001, 2003 Scott S. Emerson, M.D., Ph.D.
As an
experiment, a clinical trial must meet scientific standards
It must address a
meaningful question
·discriminate
between viable hypotheses (Science)
·
Its results must be
credible to scientific community
·Valid
materials, methods (Science,
Statistics)
·Valid
measurement of experimental outcome (Science, Clinical, Statistics)
·Valid
quantification of uncertainty in experimental procedure (Statistics)