EFPIA and PhRMA Release Joint Principles for Responsible Clinical Trial Data Sharing to Benefit Patients

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.”

“The data sharing commitments reflect EFPIA member companies’ strong support for sharing clinical trial data to benefit patients and foster scientific discovery in a way that maintains patient privacy, the integrity of regulatory systems, and incentives to invest in biomedical research,” said Richard Bergström, Director General of EFPIA. “These commitments stand as a responsible alternative to other proposals being put forth in the European Union (EU).”

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, 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 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.

“The commitments recognize the importance of sharing clinical trial data in the interest of patients, healthcare and the economy. Imperative to the success of this initiative are safeguards that ensure patient privacy, respect for integrity of regulatory systems worldwide and greater incentives for more investment in medical innovation,” said Robert Hugin, Chairman of PhRMA and Chairman and CEO of Celgene Corporation.

“The Principles demonstrate the long-held commitment of PhRMA member companies to responsible sharing of clinical trial data,” 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.”

The Principles are available at: http://transparency.efpia.eu/responsible-data-sharing and

.