EFPIA, PhRMA release joint principles for responsible data sharing
The European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Pharmaceutical Research and Manufacturers of America (PhRMA) have endorsed 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 web sites,” said Christopher Viehbacher, president of EFPIA and chief executive officer 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, which represents the European pharmaceutical industry with a membership of 33 national associations and 40 pharmaceutical companies.
Biopharmaceutical companies will dramatically increase the amount of information available to researchers, patients and the public:
- Patient-level trial data, study-level trial data, full clinical study reports and protocols from clinical trials in patients for medicines approved in the U.S. and European Union (E.U.) will be shared with 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 trial results to participating patients.
- The synopses of clinical study reports for trials in patients submitted to the FDA, EMA or national authorities of E.U. member states will be made available after approval of a new medicine or new indication.
- Companies have reaffirmed their commitment to publish clinical trial results regardless of the outcome. At a minimum, results from all phase III trials and results of significant medical importance should be submitted for publication.
“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 chief executive officer of Celgene.
Implementation of the commitments begins January, 2014.