Healthy Skepticism Library item: 12004

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Publication type: Journal Article

Hirotsu C.
A unifying approach to non-inferiority, equivalence and superiority tests via multiple decision processes.
Pharm Stat 2007 Jul-Sep; 6:(3):193-203
http://www3.interscience.wiley.com/cgi-bin/abstract/115807576/ABSTRACT?CRETRY=1&SRETRY=0

Abstract:

Two approaches of multiple decision processes are proposed for unifying the non-inferiority, equivalence and superiority tests in a comparative clinical trial for a new drug against an active control. One is a method of confidence set with confidence coefficient 0.95 improving the conventional 0.95 confidence interval in the producer’s risk and also the consumer’s risk in some cases. It requires to include 0 within the region as well as to clear the non-inferiority margin so that a trial with somewhat large number of subjects and inappropriately large non-inferiority margin for proving non-inferiority of a drug that is actually inferior should be unsuccessful. The other is the closed testing procedure which combines the one- and two-sided tests by applying the partitioning principle and justifies the switching procedure by unifying the non-inferiority, equivalence and superiority tests. In particular regarding the non-inferiority, the proposed method justifies simultaneously the old Japanese Statistical Guideline (one-sided 0.05 test) and the International Guideline ICH E9 (one-sided 0.025 test). The method is particularly attractive, changing the strength of the evidence of relative efficacy of the test drug against a control at five levels according to the achievement of the clinical trial. The meaning of the non-inferiority test and also the rationale of switching from it to superiority test will be discussed.

Keywords:
bio-equivalence • closed testing procedure • confidence set • non-inferiority • partitioning principle • superiority MeSH Terms: Binomial Distribution Confidence Intervals Controlled Clinical Trials/methods* Data Interpretation, Statistical* Decision Support Techniques* Drug Industry/standards Guidelines/standards Humans Japan Pharmacokinetics Research Design* Risk Therapeutic Equivalency