TOKYO, Feb. 2, 2015 /PRNewswire/ -- Astellas Pharma
Inc. (Tokyo: 4503, "Astellas")
announced today that the company will now make trial data available
through www.clinicalstudydatarequest.com, an independent Web site
that enables researchers to request and access clinical trial data
after approval of a research proposal by an independent review
panel.
"Transparency in the conduct of clinical trials is an important
issue for the scientific and medical community today," said
Sef Kurstjens, M.D., Ph.D., chief
medical officer of Astellas Pharma, Inc. "By making our clinical
trial data more widely available, we further its potential to
increase understanding of disease and, ultimately, to address the
unmet needs of patients around the globe."
The site, www.clinicalstudydatarequest.com, was developed to
enable researchers to request data from clinical studies and
perform further research that could help advance medical science or
improve patient care. A research proposal will be reviewed and
approved by an independent review panel, and Astellas will not be
involved in decisions made by the independent review panel.
Astellas will provide access to anonymized patient-level data from
interventional clinical trials in patients completed after
January 2010 for products and
indications that have been approved in the U.S. and/or in the
E.U. An initial list of Astellas studies available appears on
clinicalstudydatarequest.com, which will be updated regularly.
In addition, Astellas also recently revised and expanded its
Global Policy on Clinical Trial Data Disclosure, which details the
company's principles regarding registration of clinical trials,
posting and publication of trial results and scientific community
access to trial data. The policy is available at
www.astellas.com/en/corporate/disclosure/clinicalstudies.html.
About Astellas
Astellas Pharma Inc., located in
Tokyo, Japan, is a pharmaceutical
company dedicated to improving the health of people around the
world through the provision of innovative and reliable
pharmaceuticals. Astellas has approximately 18,000 employees
worldwide. The organization is committed to becoming a global
category leader in Urology, Immunology (including Transplantation)
and Infectious diseases, Oncology, Neuroscience and Diabetes
Mellitus (DM) Complications and Kidney diseases. For more
information on Astellas Pharma Inc., please visit the company Web
site at www.astellas.com/en.
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SOURCE Astellas Pharma Inc.