(Brussels – 20 May 2014): EFPIA has today launched a new gateway to clinical trials data. The new facility includes a published list of member companies’ online portals aimed at advancing responsible clinical trial data sharing.
The publication coincides with International Clinical Trials Day, which celebrates the day of the first-ever clinical trial, by James Lind on the 20th of May 1747.
A promise to develop these portals was established as part of joint EFPIA-PhRMA commitments on clinical trials data transparency, which came into full force on 1st January 2014.
EFPIA and PhRMA member companies have made great strides towards meeting these commitments, establishing diverse partnerships and various portals designed to enhance clinical trials data sharing in a responsible manner. A full list of these initiatives is available on the EFPIA website.
Richard Bergström, Director General EFPIA, stated: “I am pleased to see the progress our member companies are making implementing the EFPIA-PhRMA Principles. These commitments to data sharing serve as a common baseline across the industry that our companies can agree to, and will provide new avenues for the scientific community and patients to benefit from clinical research, while maintaining patient privacy, the integrity of national regulators, and investments in biomedical research.”
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.
EFPIA Member Companies & Clinical Trials Data:
- Biogen Idec
- Johnson & Johnson
- Merck & Co (MSD)
- Novo Nordisk
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.
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