ABSTRACT
A global multiregional clinical trial (MRCT) is an international clinical trial
conducted in multiple countries with a uniform study protocol. Its goal is
to get the drug approval in multiple countries. Therefore, it is involved with
the health authorities in multiple countries/regions. In a Q&A format, the
answer to the ICH E5 Q11 states, a multiregional trial for the purpose of
bridging could be conducted in the context of a global development program
designed for near simultaneous worldwide registration. The objectives of
such a study would be (1) to show that the drug is effective in the region
and (2) to compare the results of the study among the regions with the
intent of establishing that the drug is not sensitive to ethnic factors. The
multiregional trials are built on a common belief that the primary effects
of the drug are expected to be the same (consistency principle). Otherwise,
the trial can be conducted separately in different countries, and bridging
studies can be used if the drug is already approved in some other countries.
In recent years, the paradigm of conducting clinical trials starts to shift
from bridging studies, which are conducted after a medical product has be
approved in one or more of the three major ICH regions (U.S., EU, and
Japan), to a simultaneous drug development or global multiregional trials.
