The European Federation of Pharmaceutical Industries and Associations (EFPIA) and Pharmaceutical Research and Manufacturers of America (PhRMA) this week jointly released principles for sharing clinical trial data with patients. “Data sharing commitments will enhance research and scientific knowledge, advance patient care, and improve public health,” EFPIA and PhRMA said.
With “Principles for Responsible Clinical Trial Data Sharing: Our Commitment to Patients and Researchers,” the organizations propose biopharmaceutical firms “dramatically increase” the amount of information they make available to researchers, patients, and the general public. “At a minimum, results from all Phase III clinical trials and clinical trial results of significant medical importance should be submitted for publication,” they said.
EFPIA and PhRMA said companies that adopt the proposed principles are not only supporting the patients they aim to eventually serve, but also fostering scientific discovery. These companies will work with regulators at FDA, EMA, and/or national authorizes of EU member states to provide clinical trial results summaries upon approval of new medicines or indications, the organizations said. (As GEN recently noted, biopharmas overall have been less than receptive toward similar data-sharing initiatives.)
“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,” Richard Bergström, director general of EFPIA, said in a statement. “These commitments stand as a responsible alternative to other proposals being put forth in the European Union.”
Added EFPIA President and member company Sanofi CEO Christopher Viehbacher: “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.”
Celgene’s Robert Hugin, chairman and CEO, said that these “commitments recognize the importance of sharing clinical trial data in the interest of patients, healthcare and the economy.” Hugin, who is also chairman of PhRMA, added: “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.”
EFPIA and PhRMA said implementation of the commitments is slated to begin January 1, 2014.