EFPIA and its member companies believe that sharing clinical trial data in the best interests of patients, clinicians, medical research and the pharmaceutical industry.

 

We are committed to working with stakeholders to ensure that clinical trial information is shared responsibly, while ensuring patient anonymity and continuing to support the development of innovative new treatments with appropriate arrangements for commercial-in-confidence information.

 

The EFPIA/PhRMA Joint Principles for Responsible Clinical Trial Data Sharing, implemented on 1 January 2014, have underscored the commitment of the pharmaceutical industry to disclosing clinical trial data.  EFPIA members have made significant progress in developing processes for clinical trial data access schemes, translating principles into practice. 

 

In addition to the industry led initiatives, EFPIA welcomes the adoption of the EU clinical trial regulation (536/2014) and publication of the EMA’s Transparency Policy (Policy 0070).  We are continuing to engage with stakeholders to ensure the successful implementation, with the aim of striking a balance between responsible reporting for public health benefit and safeguarding patient confidentiality, respecting the integrity of the regulatory systems worldwide, and maintaining incentives for investments in biomedical research.

 

In the future, clinical trial data will be enhanced by the availability of real world data from patient registries, hospitals and general practitioners. It is critical that European partners in research to develop systems to maximise the potential of big data while protecting confidentiality of patient data, to further biomedical research.