EFPIA-PhRMA Principles successfully enable responsible clinical trial data sharing

Stakeholders are gathering in London, UK, this week for a workshop entitled Data Anonymization – a Key Enabler for Clinical Data Sharing. The workshop, organised jointly by the European Medicines Agency (EMA) and the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard, is but one example of efforts undertaken by a broad range of stakeholders, to enhance clinical trial data sharing. The workshop will seek to propose guiding principles to enable international data sharing – an area in which EFPIA and its member companies are leading the way.

Making research data available to qualified researchers has the great potential to advance medical research to benefit patients, by accelerating the development of new medicines and improving patient care. The biopharmaceutical industry has been at the forefront of initiatives to improve access to clinical trial data and has led the way in sharing patient-level data. Industry details its commitments to sharing clinical trial data in the joint EFPIA-PhRMA Principles for Responsible Clinical Trial Data Sharing (the Principles), which were adopted by the boards of both the European- and US-based associations in July 2013. The Principles support enhanced data sharing, while safeguarding patient privacy, respecting the integrity of national regulatory systems, and maintaining incentives for investment in biomedical research.

Today, EFPIA and PhRMA released the Report on the 2016 Member Company Survey, which details the results of a joint survey, conducted between July and September 2016, to assess the degree to which member companies had made progress in implementing the commitments under the Principles. The survey results show that 98 percent of EFPIA and PhRMA member companies share clinical trial data beyond any legal or regulatory requirements. In addition, EFPIA and PhRMA member companies documented collectively more than 1,000 requests for access to clinical trial data between 1 January 2014 (the date on which the companies began to implement the Principles) and the close of the survey – approximately 2.5 years later. Of the 935 requests on the basis of which a decision had been made, the vast majority – 80 percent – were approved, showing that considerable data sharing is now taking place.

The biopharmaceutical industry believes that the disclosure of clinical trial results and appropriate sharing of clinical trial data is in the best interests of patients, clinicians, medical research and the biopharmaceutical industry.

The new EU Clinical Trials Regulation 536/2014 will require, for example, the submission of summary results and clinical study reports to be made public, based on predefined disclosure rules.  A new EU Portal and Database at the European Medicines Agency for publicly-accessible information should be operational in the second half of 2019. Data from clinical trials can also be obtained for products that have been approved by the European Medicines Agency (via the centralised approval procedure) through policy 0043 on access to documents and policy 0070 on proactive publication and access to clinical trial data. 

The results of our survey confirm that EFPIA and PhRMA member companies have in the meantime made significant progress in developing processes for clinical trial data access schemes, in order to support the shared goal of medical and scientific advancement.

Significantly, the survey results also demonstrate that the Principles established by PhRMA and EFPIA successfully enable responsible clinical trial data sharing, and are therefore well suited for use, as others look to enhance data sharing practices and develop guiding principles.

Sini Eskola

Sini Eskola is working as Director Regulatory Strategy at EFPIA. She has a degree in pharmaceutical sciences (M.Sc)...
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