Sample size determination for a specific region in multiregional clinical trials with multiple co-primary endpoints.

ABSTRACT: Recently, multi-regional clinical trials (MRCTs), which incorporate subjects from many countries/regions around the world under the same protocol, have been widely conducted by many global pharmaceutical companies. The objective of such trials is to accelerate the development process for a drug and shorten the drug's approval time in key markets. Several statistical methods have been purposed for the design and evaluation of MRCTs, as well as for assessing the consistency of treatment effects across all regions with one primary endpoint. However, in some therapeutic areas (e.g., Alzheimer's disease), the clinical efficacy of a new treatment may be characterized by a set of possibly correlated endpoints, known as multiple co-primary endpoints. In this paper, we focus on a specific region an

SUBMITTER: Huang WS 

PROVIDER: S-EPMC5493407 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature