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.)

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.