Joint EFPIA-PhRMA Principles for Responsible Clinical Trial Data Sharing now in effect

1 January 2014

The European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Pharmaceutical Research and Manufacturers of America (PhRMA) announced that implementation of the joint Principles for Responsible Clinical Trial Data Sharing, first announced in the summer (The Pharma Letter July 24, 2013) has become effective as of January 1.

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 USA and European Union 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.

Move follows outside pressure

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