A Roadmap for Sharing Clinical Trial Data

27 August 2013

As part of the conversation on clinical trials data sharing, EFPIA and the Pharmaceutical Research and Manufacturers of America (PhRMA) this summer issued a joint proposal to enhance responsible clinical trial data sharing. What does this mean practically for research in Europe, and what are the best practices for implementation?

On August 27, a panel workshop was held in Brussels to examine these questions. A diversity of opinion leaders took part, including Dr. Ben Goldacre, Hans-George Eichler of the European Medicines Agency, patient groups representatives, and figures from the pharmaceutical industry. Access the Executive Summary and the Full Report at the bottom of this page.

After setting out data transparency principles, the industry is now making the case for self-regulation. But the question of what information – if any - should be defined as commercially confidential remains in dispute and this could hinder progress in creating a balanced, practical and trusted system for handling requests for data

A framework for data transparency run by the industry is more likely to strike the balance between satisfying legitimate requests for access whilst protecting patient privacy and commercial confidentiality, says Richard Bergström, Director General of the European Federation of Pharmaceutical Industries and Associations (EFPIA). “The European Medicines Agency (EMA) is saying that as regulator, it needs to be in control, but we as the industry think we should do it ourselves,” Bergström told delegates at a workshop convened by EFPIA to set out new principles for clinical data sharing and seek feedback from transparency campaigners and patients’ groups on how they should be applied.

Richard Bergström promised that the principles, which will also be applied by EFPIA’s US counterpart the Pharmaceutical Researchand Manufacturers of America (PhRMA), will “dramatically increase” the availability of data. EFPIA and PhRMA will draw up a code of conduct that will be a requirement of membership and will monitor compliance.

But while there is a consensus that protecting patient privacy must be at the heart of any system for data access, there is no agreement on the status of confidential commercial information. In particular, the workshop highlighted the considerable distance between the European Medicines Agency (EMA) and the industry on this issue.


EFPIA Director General Richard Bergström explains the EFPIA PhRMA data sharing agreement

Session 1 Best practices in the use of clinical trial data

Session 2 : Building a data sharing health infrastructure

Session 3 : Balancing public health and commercial confidentiality

Richard Bergström and Ben Goldacre debate the data sharing agreement