抄録
Multinational clinical trials are considered to be one of the effective means for solving many issues including the “drug lag” problem facing regulatory authorities and pharmaceutical companies in Japan. Multinational Asian clinical trials are of particular interest for the Japanese pharmaceutical community and have attracted attention recently due to the advantages such trials can offer, such as cross-regional data sharing and enrolling sufficient patients. However, only a few reports on multinational Asian clinical trials are available. Considering this background, this article provides a detailed analysis of the current multinational clinical trial status focusing on the Asian region and proposes a basis for development strategies for clinical trials in Japan such as study design streamlining and country and region selections. We compiled clinical trial data and created a secondary database to analyze the current multinational clinical trial status involving Asian countries by extracting information from ClinicalTrials.gov (http://clinicaltrials.gov/), a website hosted by the U.S. National Institutes of Health, through the National Library of Medicine in collaboration with the U.S. Food and Drug Administration. As a result of this analysis, it was found that multinational Asian clinical trials have been conducted with a wide variation in involvement of countries and regions. Also the trends of characteristic involvement of different countries and regions, vary with the study designs and therapeutic areas. We therefore conclude that clinical trial development strategies including the selection of countries and regions need to reflect the individual positions of studies in the clinical context as well as the characteristics of compounds. Also, in the drastically changing climate of multinational clinical trials, it is crucial to keep updating the latest trend of multinational clinical trials in order to shape good development strategies.
