Premium
Efficient clinical trials in Japan: Bridging studies versus participation in global clinical trials
Author(s) -
Shirotani Mari,
Suwa Toshio,
Kurokawa Tatsuo,
Chiba Koji
Publication year - 2014
Publication title -
the journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.92
H-Index - 116
eISSN - 1552-4604
pISSN - 0091-2700
DOI - 10.1002/jcph.216
Subject(s) - bridging (networking) , clinical trial , medicine , phases of clinical research , computer science , computer network
The required number of Japanese subjects was compared between the Bridging (BG) filing strategy described in ICH‐E5 for drugs approved from 1998 to 2012, in which foreign phase 3 results were used together with a BG study conducted to confirm optimum Japanese dose, and global clinical trial (GCT) strategies in which the number was simulated from the foreign phase 3 studies. The simulated number from the GCT strategy was smaller than that of the BG, suggesting that the GCT strategy could be expected to reduce Japanese clinical trial costs. However, two exceptions were found, namely for preventive drugs and drugs for children, because of the large scales of foreign phase 3 studies.