Transparency and Sharing: UCB Expands Access to Clinical Study Data
- First midcap company to enter Multi-Sponsor Environment for data sharing
- Reinforces UCB’s commitment to the advancement of medical science and improved patient care
- In line with EFPIA and PhRMA principles for Responsible Clinical Trial Data Sharing
- Online portal will provide access to key studies of UCB’s core medicines
Brussels, Belgium– 01 August 2014, 0700 CEST – UCB announces that it has joined the Multi-Sponsor Environment which allows for the responsible sharing of clinical study data as a way to uncover new scientific knowledge or insights, advance medicine and ultimately benefit patients and other stakeholders. In line with its vision for patient-centered leadership, UCB is the first midcap biopharma company to join this new environment.
The environment (https://clinicalstudydatarequest.com) allows researchers to request access to anonymised patient level data and supporting documents from clinical studies to conduct further research. Research proposals are reviewed by an Independent Review Panel. At present, UCB will accept requests relating to all clinical studies that were considered ‘pivotal studies’ for purposes of regulatory approval of the core UCB medicines. Requests for access to additional clinical study data will be considered on a case-by-case basis.
“Because we believe that this will lead to better solutions for patients, we have committed to sharing data from our clinical studies in a responsible way. We hope this will enhance disease understanding, generate new insights and help develop new treatments,” said Professor Dr. Iris Loew-Friedrich, Chief Medical Officer and Executive Vice President, UCB.
UCB’s policy on data sharing embraces the Principles for Responsible Clinical Trial Data Sharing released by the U.S. and European pharmaceutical trade associations, PhRMA and EFPIA.
Further information on UCB’s policy on disclosure of clinical study information can be found on our website.
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UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With more than 8500 people in approximately 40 countries, the company generated revenue of € 3.4 billion in 2013. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news
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