Joint EFPIA-PhRMA Principles for Responsible Clinical Trial Data Sharing Become Effective Today
Data Sharing Commitments Enhance Research and Scientific Knowledge, Advance Patient Care and Improve Public Health
Brussels and Washington, D.C (January 1, 2014) — The European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Pharmaceutical Research and Manufacturers of America (PhRMA) are pleased to announce that implementation of the joint Principles for Responsible Clinical Trial Data Sharing begins today.
Researchers are now able to submit proposals to receive access to patient level data, protocols, and clinical study reports for new medicines approved in the U.S and EU after January 1, 2014. The biopharmaceutical sector’s commitment to data sharing provides new avenues for the scientific community and patients to benefit from clinical research, while maintaining patient privacy, the integrity of national regulators, and incentives for companies to make long-term investments in biomedical research.
“Today, EFPIA and PhRMA members are opening a window to new data sharing requests,” said Christopher Viehbacher, President of EFPIA and CEO of Sanofi. “By endorsing the Principles, biopharmaceutical companies are committing to enhance data sharing efforts by making additional information available to the public, patients who participate in clinical trials and qualified researchers. Ultimately this move aims to benefit patients and foster scientific discovery.”
“The data sharing commitments reflect EFPIA member companies’ strong support for sharing clinical trial data to foster scientific research. The initiative has been welcomed by the EU’s research community. We look forward to working with these important stakeholders to ensure that our data-sharing regime in Europe continues to promote research excellence and competitiveness,” said Richard Bergström, Director General of EFPIA.
Effective today as part of the new commitments, biopharmaceutical companies will dramatically increase the amount of information available to researchers, patients and members of the public. Companies will publish their procedures for requesting data and the industry will track the progress of implementing the principles, including issuing a report later in 2014.
The EFPIA-PhRMA Principles include:
- Patient-level clinical trial data, study-level clinical trial data, full clinical study reports, and protocols from clinical trials in patients for medicines approved in the United States and EU beginning this year will be shared with qualified scientific and medical researchers upon request and subject to terms necessary to protect patient privacy and confidential commercial information. Researchers who obtain such clinical trial data will be expected to publish their findings.
- Companies will work with regulators toward a mechanism to provide factual summaries of clinical trial results to patients who participate in clinical trials.
- The synopses of clinical study reports for clinical trials in patients submitted to the Food and Drug Administration, European Medicines Agency, or national authorities of EU member states will be made publicly available upon the approval of a new medicine or new indication.
- Biopharmaceutical companies also reaffirm their commitment to publish clinical trial results regardless of the outcome of the trials. At a minimum, results from all phase 3 clinical trials and clinical trial results of significant medical importance should be submitted for publication.
“Implementing these commitments builds on our ongoing collaboration across the scientific ecosystem and recognizes the importance of responsibly sharing clinical trial data in the best interest of patients. Imperative to the success of this initiative are the safeguards that ensure patient privacy, respect the integrity of regulatory systems worldwide and foster ongoing medical innovation,” said Robert J. Hugin, Chairman of PhRMA and Chairman and CEO of Celgene Corporation.
“Companies make substantial investments to explore new medicines, including the clinical trials that determine safety and efficacy – over $1 billion in research for every approved medicine. Today’s implementation of the PhRMA-EFPIA Principles will contribute to the ability of biopharmaceutical companies to continue to make these investments in new medicines to treat patients’ unmet medical needs,” said PhRMA President and CEO John Castellani. “They supplement PhRMA’s Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results, which were strengthened in 2004 and again in 2009.”
EFPIA represents the pharmaceutical industry operating in Europe. Through its direct membership of 33 national associations and 40 leading pharmaceutical companies, EFPIA provides the voice of 1,900 companies committed to researching, developing and bringing new medicines to improve health and quality of life around the world. The pharmaceutical industry invests 30 billion on research and development per year in Europe and directly employs 700,000 people including 116,000 in R&D units in Europe.
EFPIA members are committed to delivering innovative medicines to address unmet needs of patients and reducing the burden of chronic diseases for Europe’s ageing population. EFPIA believes in close cooperation with its stakeholders to help create sustainable healthcare systems and to develop prompt responses to health threats in Europe.
The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading innovative biopharmaceutical research and biotechnology companies, which are devoted to discovering and developing medicines that enable patients to live longer, healthier, and more productive lives. Since 2000, PhRMA member companies have invested approximately $550 billion in the search for new treatments and cures, including an estimated $48.5 billion in 2012 alone.
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