Stakeholders are gathering in London this week for a workshop entitled Data Anonymization – a Key Enabler for Clinical Data Sharing. The workshop, jointly organized 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 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 PhRMA 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 (or Principles) which were adopted by the boards of both 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 collectively documented more than 1,000 requests for access to clinical trial data between January 1, 2014 (the date that the companies began to implement the Principles), and the close of the survey. Of the 935 requests on 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 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 results of the survey confirm that EFPIA and PhRMA member companies have 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.
Olivia Shopshear
Olivia is a director of Science and Regulatory Advocacy at the Pharmaceutical Research and Manufacturers of America (PhRMA). Olivia has extensive multi-disciplinary program management and policy experience in the biopharmaceutical and biodefense industries, ranging from pre-clinical product development to commercial tech transfer to global supply chain management. She currently leads PhRMA’s clinical trial data transparency advocacy program.
Olivia Shopshear
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EFPIA-PhRMA Principles successfully enable responsible clinical trial data sharing
Clinical Trials
EFPIA-PhRMA Principles successfully enable responsible clinical trial data sharing
EFPIA-PhRMA Principles successfully enable responsible clinical trial data sharing