An alternate approach for sample size determination in a multi-regional trial

Abstract

Now we develop a tolerance interval considering multiple components in the variance from the measurements to deal with the environment or ethnic factor in the multi-regional trial. The idea is to construct a tolerance interval for a multi-regional trial under a sampling plan. Assuming that the environmental or ethnic effect exists, a sampling plan is derived to ensure that there is a desired probability for the tolerance interval. In this paper, we address the issue that the environmental or ethnic effect exists among regions to design a multi-regional trial.

Keywords:

• Acceptance criteria
• clinical trials
• efficacy
• heterogeneity
• sample size determination

Mathematics Subject Classification:

• Primary 62K99; Secondary 62-07