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:
“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.