Advances and Applications in Statistics
Volume 4, Issue 1, Pages 1 - 14
(April 2004)
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THERAPEUTIC EQUIVALENCE ASSESSMENT (TEA) FOR EXPONENTIAL DATA
K. J. Peschell (U. S. A.), S. Bae (U. S. A.), R. Shanmugam (U. S. A.), A. A. Bartolucci (U. S. A.) and K. P. Singh (U. S. A.)
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Abstract: Active
control equivalence trials (ACETs), conducted
with the goal of demonstrating therapeutic
equivalence, are of growing importance to the
pharmaceutical industry, clinical medicine,
government, and academia. In this paper,
therapeutic equivalence is defined in terms of
equivalent clinical outcome (e.g., survival)
without regard to assessment of bioequivalence.
The likelihood-ratio-based asymptotic fiducial
and Bayesian methods for therapeutic
equivalence assessment (TEA) are developed in
the context of survival analysis, using the
exponential distribution. The methods are
illustrated using leukemia remission data. |
Keywords and phrases: fiducial method, Bayesian method, therapeutic equivalence, clinical trials, progressive censored data. |
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