ABSTRACT
In most jurisdictions around the world, licensing and registration of health products depend wholly or partially on evidence based on data generated from clinical trials, typically randomized, conducted across the globe. Many of those trials are conducted simultaneously in multiple countries/regions using a single trial protocol. Such trials are often called multiregional clinical trials (MRCTs). Successful design and execution of MRCT that generates data acceptable to regulatory authorities requires thoughtful planning of all aspects of the trial. Specifically, the sponsor must identify and address all known regulatory, clinical, operational, statistical, and ethical issues while also putting in place structures and processes for dealing with unanticipated issues that may significantly impact on the trial conduct and generated data. This section provides an overview of critical clinical, operational, statistical, and ethical issues to consider when planning, executing, analyzing, and interpreting MRCT.
