EFPIA, PhRMA release principles for clinical trial data sharing

The two major pharma representative corporations in Europe and the US have strengthened their long-standing commitment to public health by welcoming independent reviews of clinical trial data.

In a statement released today, the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Pharmaceutical Research and Manufacturers of America (PhRMA) have endorsed "Principles for Responsible Clinical Trial Data Sharing: Our Commitment to Patients and 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. These commitments stand as a responsible alternative to other proposals being put forth in the European Union (EU)."

Richard Bergström, Director General of EFPIA.

Under the new commitments, biopharmaceutical companies will have to dramatically increase the amount of information available to researchers, patients, and members of the public. They will also have to publish clinical trial results, regardless of the outcome.

"Companies routinely publish their clinical research, collaborate with academic researchers, and share clinical trial information on public websites. 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."

Christopher Viehbacher, President of EFPIA and CEO of Sanofi.

Other commitments include sharing patient-level clinical trial data, study-level clinical trial data, full clinical study reports as well as protocols from clinical trials in patients for medicines approved in the United States and European Union with qualified scientific and medical researchers upon request and subject to terms necessary to protect patient privacy and confidential commercial information.

But some critics believe that only allowing qualified researchers to view the data is failing to allow sufficient third-party scrutiny, which in turn leads to the risk of drugs being approved and used without proper examination of risks, benefits and side effects.

"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."

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. 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."

PhRMA President and CEO John Castellani.

Implementation of the commitments will begin on 1st January 2014.