Astellas Pharma, based in Japan, 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. "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 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.
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.