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

Feng-shou Ko

Communications in Statistics - Theory and Methods, 2020, vol. 49, issue 4, 997-1007

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.

Date: 2020
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DOI: 10.1080/03610926.2018.1554133

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