Improving access to research data
Posted by
06-Aug-2014
Clinical trials produce a wealth of information about the safety of medicines and how they work in patients. This research is essential to bringing new therapies to patients.
The data can be used to accelerate medical innovation. At UCB, we want to maximize the potential of information generated during clinical trials while remaining committed to preserving patient privacy.
That's why UCB has become the first mid-cap biopharma company to sign up to an online portal offering responsible data sharing.
We have been working with the European Federation of Pharmaceutical Industries and Associations (EFPIA) to develop a new approach to clinical trial data transparency and this initiative is a landmark for our industry.
The new portal, where several large biopharma companies have also become members, will provide access to data from key studies of UCB's core medicines. It 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.
This positive step could pave the way for researchers outside UCB to uncover new scientific knowledge or insights. Provided the privacy of those who participated in clinical trials is protected, we are committed to initiatives that can improve the lives of patients.
We will accept requests for data relating to all clinical studies considered to be 'pivotal' for the purposes of regulatory approval of our core medicines. Requests for access to additional clinical study data will be considered on a case-by-case basis.
UCB’s policy on data sharing embraces the Principles for Responsible Clinical Trial Data Sharing released by EFPIA and the U.S. pharmaceutical trade association, PhRMA. To know more about our work in this area, see our website.
The data can be used to accelerate medical innovation. At UCB, we want to maximize the potential of information generated during clinical trials while remaining committed to preserving patient privacy.
That's why UCB has become the first mid-cap biopharma company to sign up to an online portal offering responsible data sharing.
We have been working with the European Federation of Pharmaceutical Industries and Associations (EFPIA) to develop a new approach to clinical trial data transparency and this initiative is a landmark for our industry.
The new portal, where several large biopharma companies have also become members, will provide access to data from key studies of UCB's core medicines. It 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.
This positive step could pave the way for researchers outside UCB to uncover new scientific knowledge or insights. Provided the privacy of those who participated in clinical trials is protected, we are committed to initiatives that can improve the lives of patients.
We will accept requests for data relating to all clinical studies considered to be 'pivotal' for the purposes of regulatory approval of our core medicines. Requests for access to additional clinical study data will be considered on a case-by-case basis.
UCB’s policy on data sharing embraces the Principles for Responsible Clinical Trial Data Sharing released by EFPIA and the U.S. pharmaceutical trade association, PhRMA. To know more about our work in this area, see our website.
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This is excellent news. And how things should be.