U.S. News Room
Daiichi Sankyo to Expand Access to Clinical Trial Data
February 02, 2016
Tokyo, Japan (February 2, 2016) - Daiichi Sankyo Co., Ltd. (head office: Chuo-ku, Tokyo; Representative Director, President and CEO: Joji Nakayama (hereinafter "Daiichi Sankyo"), has announced today that it will share clinical trial data to qualified researchers through the clinicalstudydatarequest.com system.
Beginning today, qualified researchers may submit research proposals to clinicalstudydatarequest.com requesting data from Daiichi Sankyo-sponsored trials for approved medicines in the EU and US. Daiichi Sankyo will provide data for approved medicines and indications from 01 January 2014 onward. Access is mediated by an independent review panel.
"Sharing clinical data from trials sponsored by Daiichi Sankyo with qualified researchers helps foster additional scientific insights and provides a mechanism for further understanding of our medicines, which ultimately is a benefit to patient healthcare" says Mahmoud Ghazzi, MD, PhD, Global Head of Development for Daiichi Sankyo.
Once a qualified request is approved by the independent panel, and deemed clear of restrictions, Daiichi Sankyo will anonymize the information to protect patient privacy, and will make requested analyses available in a secure electronic environment. Daiichi Sankyo will ensure all applicable laws and regulations are adhered to throughout this process.
Daiichi Sankyo registers clinical trials and discloses clinical trial results according to all local and regional laws and requirements. As Daiichi Sankyo is a member of the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Pharmaceutical Research and Manufacturers of America (PhRMA), this initiative is also consistent with the EFPIA-PhRMA Principles for Responsible Clinical Trial Data Sharing, which can be found below:
For further information on Daiichi Sankyo clinical trials, please follow the link below:
About Daiichi Sankyo
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical products to address diversified, unmet medical needs of patients in both mature and emerging markets. With over 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 17,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to its strong portfolio of medicines for hypertension, dyslipidemia, bacterial infections, and thrombotic disorders, the Group's research and development is focused on bringing forth novel therapies in cardiovascular-metabolic diseases, pain management, and oncology, including biologics. For more information, please visit: www.daiichisankyo.com.
Yasuki Minobe (Global)
Daiichi Sankyo Group
Corporate Communications Department
+81 (3) 62251126
Daiichi Sankyo Europe GmbH (Europe)
+49 89 7808569
Daiichi Sankyo, Inc. (US)