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.” Read More