Editorial
Multi-regional clinical trials – What are the challenges?†‡§
First published: 06 September 2010
No abstract is available for this article.
REFERENCES
- 1 International Conference on Harmonization. Ethnic factors in the acceptability of foreign clinical data (ICH E-5). CPMP/ICH/289/95. The European Agency for the Evaluation of Medicinal Products: London, UK, 1998.
- 2 Bridging study, Asian Pacific Economic Corporation (APEC) Joint Research Project. Center for Drug Evaluation, Department of Health, Executive Yuan, ROC (Taiwan). The 17th APEC ISTWG Meeting, August 1999. Available at: http://www.cde.org.tw/bse_website/english/background.html.
- 3Hsiao CL, Chern HD, Chen LK, Lin MS. Algorithm for evaluation of bridging studies in Taiwan. Drug Information Journal 2003; 37: 123(s)–128(s).
- 4Wang SJ. Bridging studies versus pre-specified regions nested in global trials. Special Issue on ‘Partnership in Hormonization for Global Drug Development in Asia/Pacific’. Drug Information Journal 2009; 43: 27–34.
- 5International Conference on Harmonization Guideline E5. Questions & answers for the ICH E-5 guidance on ethnic factor in the acceptability of foreign data. 2006. Available at: http://www.ich.org/cache/compo/276-254-1.html.
- 6 Ministry of Health, Labour and Welfare. Basic principles on global clinical trials. 2007. Available at: http://www.pmda.go.jp/english/service/pdf/notifications/0928010-e.pdf.
- 7 European Medicines Agency, Committee for Medicinal Products for Human Use. Reflection paper on the extrapolation on results from clinical studies conducted outside Europe to the EU-population. EMEA/CHMP/EWP/692702/2008, 2009.