Disclosure Policy of the Astellas Group for Information on Conduct and Results of
The Astellas Group (*1) (hereinafter collectively Astellas) supports a general concept
that significant benefits of public health are acquired from information on the
conduct and results of clinical trials widely provided to healthcare professionals
and patients. Astellas has a policy of transparency in disclosing this information
to the public according to the recommendation by the International Federation of
Pharmaceutical Manufacturers and Associations (IFPMA). The policy is as follows:
- Astellas discloses information on controlled clinical investigations other
than phase 1 trials (*2) sponsored and conducted mainly by Astellas, which were
started after October 1, 2007, or earlier as required by regulation or industry
agreement. Astellas may register other studies as necessary to facilitate publication
in peer-reviewed medical journals. All clinical trial information we disclose is
posted on the website, Clinicaltrials.gov.
- Astellas discloses the results of controlled clinical investigations other
than phase 1 trials (*2) sponsored and conducted mainly by Astellas which were started
after October 1, 2007, or earlier as required by regulation or industry agreement.
The results will be registered at an appropriate timing indicated by the Authority's
guideline. All results of the studies we disclose will be posted on the website,
- Astellas discloses information on the conduct of hypothesis testing clinical
trials (*2) sponsored by Astellas in Japan, which is posted on the website of the
Japan Pharmaceutical Information Center, clinicaltrials.jp/user/cte_main.jsp (*1)
Astellas Pharma Inc. and its group companies worldwide (*2) Control is a standard
against which experimental observations may be evaluated. Controlled clinical investigation
means clinical studies with targeted patients containing at least one control group
so as to provide firm evidence to safety and/or efficacy to support product claims.
Phase-1 studies are not included in the controlled clinical investigations.