Efficient clinical trials in Japan: Bridging studies versus participation in global clinical trials

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) st...

Full description

Saved in:
Bibliographic Details
Published in:Journal of clinical pharmacology 2014-04, Vol.54 (4), p.438-445
Main Authors: Shirotani, Mari, Suwa, Toshio, Kurokawa, Tatsuo, Chiba, Koji
Format: Article
Language:English
Subjects:
bridging study
Clinical trials
Clinical Trials as Topic
Drug Approval
Drugs, Investigational
global clinical trial
Humans
Japan
regulatory science
Sample Size
Studies
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary: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.
ISSN:0091-2700
1552-4604
DOI:10.1002/jcph.216