Multinational (Global) Trial

Abstract

Multinational clinical trials are trials conducted in more than one country using a common protocol. They have become increasingly common and have many advantages, such as access to a large patient population and the potential to obtain a broadly generalizable conclusion. However, these trials also have a number of practical difficulties, such as differences among the countries in language, import/export procedures, and regulatory and legal requirements. In addition, country‐by‐treatment interactions have frequently been found in these trials, leading to difficulties in interpreting the results. For example, the MERIT‐HF trial, which evaluated metoprolol in patients with heart failure, found an overall hazard ratio for total mortality of 0.66, but a hazard ratio of 1.05 in the United States. There is particular concern that differences among countries hinder the ability to evaluate the cost effectiveness of an experimental treatment.

A Bayesian Approach to Evaluating Regional Treatment Effect in a Multiregional Trial

“…A multiregional trial is a trial conducted in more than one region under a common protocol (Snapinn, 2008). The design provides a practical way to recruit sufficient subjects to achieve the trial objective within a reasonable time frame, and also presents a better basis for subsequent generalization of the trial findings to several populations over the world.…”

An Approach to Rationalize Partitioning Sample Size into Individual Regions in a Multiregional Trial

“…The 11th Q&A for the ICH-ES guideline discusses the concept of a multiregional trial (3). A multiregional trial is a trial conducted in more than one region using a common protocol (8).…”