Clinical Statistics for Nonstatisticians

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Session 9: A Trial for Equivalence

Session Chair(s)

Rafe Donahue, PhD

Chief Statistical Advisor

Bufnagle Consulting, United States

Discuss statistical issues in trials designed to demonstrate clinical equivalence or non-inferiority. Special attention will be directed toward proper ways to derive inferences in such trials.

Sample size determination
Hypothesis testing approach
Confidence interval approach
Interpreting the results