Healthy Skepticism Library item: 9011

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Publication type: Journal Article

Miki S.
[Why multi-national clinical trials now?--Industry perspective]
Gan To Kagaku Ryoho. 2007 Feb; 34:(2):293-6.
http://www.pier-online.jp/0385-0684/contents_abstract.php?serial_no=34020&seq=39

Abstract:

Clinical trial environment in Japan has issues such as high clinical development cost, resource-intensive and time-consuming preparation for clinical trial conduct in each clinical site, long “White Space” and slow speed in pt.recruitment. As a result of the Guideline revision in Nov., 2005, overseas’ Phase III data is now usable as pivotal data for NDA submissions. Therefore, acceleration of “hollowing out of clinical trails for registration in Japan has been the significant concern. Under such circumstances, the possible solution would be to participate in the Multi-National Clinical Trials.” While other Asian countries, EU and the US have rich precedents and experiences in conducting Multi-National Clinical Trials, Japan was left alone and other Asian countries do not need any collaboration with Japan. It is proposed that Japan take initiative to set up the network such as “Asian Clinical Trial Group” and collaborate with other Asian countries from the beginning of early stage development. Eventually, Asia should become the third region to create clinical evidence, same as to EU and the US.

Keywords:
Publication Types: English Abstract MeSH Terms: Asia Clinical Trials/legislation & jurisprudence* Drug Industry* Guideline Adherence Humans International Cooperation* Japan Multicenter Studies

Notes:

Japanese.