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EFPIA statement on BMJ study on company policies for clinical trials transparency

EFPIA and its member companies believe that sharing clinical trial data is in the best interests of patients, clinicians, medical research and the pharmaceutical industry. EFPIA is committed to working with stakeholders to ensure that clinical trial information is shared responsibly, while guaranteeing patient anonymity and continuing to support the development of innovative treatments with appropriate arrangements for commercial-in-confidence information.

EFPIA welcomes the focus on transparency afforded by the AllTrials assessment of pharmaceutical companies’ policies on transparency around clinical trials. Industry engagement with the process underlines the importance of the issue to EFPIA and its member companies and we would welcome further dialogue with AllTrials and the study authors on multiple aspects of the audit they have conducted.  

The legal and policy requirements as well as voluntary commitments with regards to clinical trial data transparency are complex: they develop continuously, vary slightly between the regions and often require detailed knowledge in order to keep track of all of them.

The pharmaceutical industry has been at the forefront of initiatives to improve access to clinical trial data [1, 2, 3, 4]. Industry’s commitments are further reflected in the joint EFPIA-PhRMA Principles for Responsible Clinical Trial Data Sharing [5]. Under these Principles, biopharmaceutical companies commit to enhance data sharing with qualified researchers, share results with the patients who participate in clinical trials, enhance public access to the clinical study information, and reaffirm their commitment to publish clinical trial results.  

Together with PhRMA, EFPIA recently conducted a survey to assess the degree to which member companies had implemented the commitments under the PhRMA-EFPIA Principles for Responsible Clinical Trial Data Sharing. We surveyed all companies that had been full members of either EFPIA or PhRMA for at least one year at the time of the survey’s launch. In total, 44 companies met these inclusion criteria and we achieved a 100% response rate for the survey. While we are working on the publication of the summary report of the survey, we are pleased to report preview that the survey results confirm 98% of our members share clinical trial data beyond any legal or regulatory requirements. Our members accomplish this in a variety of ways, including participation in an external data sharing platform, publication of trial results in the scientific literature, posting clinical trial information on their own websites, and sharing data with qualified researchers through direct dissemination. In addition, PhRMA and EFPIA member companies collectively documented the receipt of over 1,000 requests for access to clinical trial data in the period between the effective date of the Principles (January 1, 2014) and the launch of the survey (July 2016). Of the requests on which a decision had been made, 80% (750/935) were approved. Implementation of the PhRMA-EFPIA Principles further improves transparency around clinical trial information, and ensures that when more detailed data is needed to advance medical research, there is a mechanism in place to provide the required information.

In addition to the industry-led initiatives, EFPIA welcomes the adoption of the EU Clinical Trials Regulation (536/2014), which will come in to application in 2019, and the EMA’s Transparency Policy (Policy 0070), which is applied to the clinical data that supports all centrally-approved (EMA) marketing authorisations submitted after January 2015.  We are continuing to engage with stakeholders to ensure the successful implementation of both the EU CT Regulation and the Policy 0070, 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. 

EFPIA and its members will continue to work with stakeholders, including AllTrials, to further develop the work that has been initiated by the audit study. This will help to ensure there is a continuous true reflection of how the pharmaceutical industry is striving to meet its responsibilities towards sharing of clinical trials data.


References:

[1] IFPMA Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases. 6 January 2005. Link: http://clinicaltrials.ifpma.org/clinicaltrials/fileadmin/files/pdfs/FINAL%20Position%20Clinical%20Trials%20Information%20January%2005.pdf.

[2] IFPMA Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases. Updated 10 November 2009. Link: http://clinicaltrials.ifpma.org/clinicaltrials/fileadmin/files/pdfs/EN/November_10_2009_Updated_Joint_Position_on_the_Disclosure_of_Clinical_Trial_Information_via_Clinical_Trial_Registries_and_Databases.pdf

[3] PhRMA Principles on Conduct of Clinical Trials. Communication of Clinical Trials Results. April 2009. Link: http://phrma-docs.phrma.org/sites/default/files/pdf/042009_clinical_trial_principles_final.pdf

[4] IFPMA Joint Position on the Publication of Clinical Trial Results. 10 June 2010.  Link: http://clinicaltrials.ifpma.org/clinicaltrials/fileadmin/files/pdfs/20100610_Joint_Position_Publication_10Jun2010.pdf

[5] EFPIA-PhRMA Principles for Responsible Clinical Data Sharing. July 2013. Link: https://www.efpia.eu/media/25189/principles-for-responsible-clinical-trial-data-sharing.pdf

 

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