A Bayesian approach to pilot-pivotal trials for bioequivalence assessment.

ABSTRACT:

Background

To demonstrate bioequivalence between two drug formulations, a pilot trial is often conducted prior to a pivotal trial to assess feasibility and gain preliminary information about the treatment effect. Due to the limited sample size, it is not recommended to perform significance tests at the conventional 5% level using pilot data to determine if a pivotal trial should take place. Whilst some authors suggest to relax the significance level, a Bayesian framework provides an alternative for informing the decision-making. Moreover, a Bayesian approach also readily permits possible incorporation of pilot data in priors for the parameters that underpin the pivotal trial.

Methods

We consider two-sequence, two-period crossover designs that compare test (T) and reference (

SUBMITTER: Lv D 

PROVIDER: S-EPMC10729540 | biostudies-literature | 2023 Dec

REPOSITORIES: biostudies-literature