EFPIA/PhRMA: Joint Principles for Responsible Clinical Trial Data Sharing

EFPIA/PhRMA: Joint Principles for Responsible Clinical Trial Data Sharing to Benefit Patients
Media Release: July 24, 2013

The European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Pharmaceutical Research and Manufacturers of America (PhRMA) today strengthened their long-standing commitment to enhancing public health by endorsing joint “Principles for Responsible Clinical Trial Data Sharing: Our Commitment to Patients and Researchers.”

“Companies routinely publish their clinical research, collaborate with academic researchers, and share clinical trial information on public websites,” said Christopher Viehbacher, President of EFPIA and CEO of Sanofi. “By endorsing the Principles, biopharmaceutical companies commit to enhance these efforts by making additional information available to the public, patients who participate in clinical trials, and to qualified researchers.

Under the new commitments, biopharmaceutical companies will dramatically increase the amount of information available to researchers, patients, and members of the public.

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 European Union 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 encouraged to publish their findings.

Companies will work with regulators to provide a factual summary 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 [FDA], European Medicines Agency [EMA], or national authorities of EU member states will be made publicly available upon the approval of a new medicine or new indication.

Biopharmaceutical companies have also reaffirmed their commitment to publish clinical trial results regardless of the outcome. At a minimum, results from all phase 3 clinical trials and clinical trial results of significant medical importance should be submitted for publication….

Implementation of the commitments begins on January 1, 2014. The Principles are available at http://transparency.efpia.eu/responsible-data-sharing and http://onphr.ma/18yru3e.