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Superiority, equivalence and non-inferiority trials

ICH E9 (1998) Note for Guidance on Statistical Principles for Clinical Trials  [Pg.17]

Typically, later phase trials tend to have the confirmatory elements while the earlier phase studies proof of concept, dose-finding etc. are viewed as exploratory. Indeed an alternative word for confirmatory is pivotal. It is the confirmatory elements of our trials that provide the pivotal information from a regulatory perspective. [Pg.17]

Usually it is the primary endpoint(s) that provides the basis of the confirmatory claims and exploratory aspects are relegated to the secondary (or exploratory) endpoints. [Pg.17]

A clear distinction should also be made between superiority, equivalence and [Pg.17]


See other pages where Superiority, equivalence and non-inferiority trials is mentioned: [Pg.17]    [Pg.17]   


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Equivalence trials

Inferior

Non-inferiority

Non-inferiority trial

Superior

Superiore

Superiority

Superiority trials

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