Current Issues in Non-Inferiority Trials¶
Fleming, T. R. (2008). Current Issues in Non-Inferiority Trials. Statistics in Medicine, 27(3), 317-332.
Cited by¶
1 citation across 1 artifact.
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Mechanisms¶
- Noninferiority Margin Protocol
- And repeated across successive approvals it enables biocreep: each new option noninferior to the last-approved one, the standard ratcheting downward a margin at a time until the newest entrant is markedly worse than the original.
This sourceExplains biocreep as progressive loss of an established treatment effect when repeated noninferiority trials use successive active controls and margins.
- And repeated across successive approvals it enables biocreep: each new option noninferior to the last-approved one, the standard ratcheting downward a margin at a time until the newest entrant is markedly worse than the original.
Verification¶
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