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EFPIA, PhRMA trial data sharing plan goes into effect

Thursday, January 2, 2014

The European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Pharmaceutical Research and Manufacturers of America (PhRMA) have implemented the joint Principles for Responsible Clinical Trial Data Sharing.

Researchers now are able to submit proposals to receive access to patient-level data, protocols and clinical study reports for new medicines approved in the U.S and E.U. after Jan. 1. The biopharmaceutical sector’s commitment to data sharing provides new avenues for the scientific community and patients to benefit from clinical research, while maintaining patient privacy, the integrity of national regulators and incentives for companies to make long-term investments in biomedical research.

“EFPIA and PhRMA members are opening a window to new data sharing requests,” said Christopher Viehbacher, president of EFPIA and CEO of Sanofi. “By endorsing the principles, biopharmaceutical companies are committing to enhance data sharing efforts by making additional information available to the public, patients who participate in clinical trials and qualified researchers. Ultimately, this move aims to benefit patients and foster scientific discovery.”

“The data sharing commitments reflect EFPIA member companies’ strong support for sharing clinical trial data to foster scientific research. The initiative has been welcomed by the E.U.’s research community,” said Richard Bergström, director general of EFPIA.

Biopharmaceutical companies will dramatically increase the amount of information available to researchers, patients and members of the public. Companies will publish their procedures for requesting data and the industry will track the progress of implementing the principles, including issuing a report later in 2014.

The EFPIA-PhRMA Principles include:

  • 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 U.S. and E.U., beginning this year, 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 expected to publish their findings.
  • Companies will work with regulators toward a mechanism to provide factual summaries 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 FDA, EMA or national authorities of E.U. member states will be made publicly available upon the approval of a new medicine or new indication.
  • Biopharmaceutical companies also reaffirm their commitment to publish clinical trial results regardless of the outcome of the trials. At a minimum, results from all phase III clinical trials and clinical trial results of significant medical importance should be submitted for publication.

“Implementing these commitments builds on our ongoing collaboration across the scientific ecosystem and recognizes the importance of responsibly sharing clinical trial data in the best interest of patients. Imperative to the success of this initiative are the safeguards that ensure patient privacy, respect the integrity of regulatory systems worldwide and foster ongoing medical innovation,” said Robert J. Hugin, chairman of PhRMA and chairman and CEO of Celgene.

“Companies make substantial investments to explore new medicines, including the clinical trials that determine safety and efficacy—over $1 billion in research for every approved medicine. The implementation of the PhRMA-EFPIA Principles will contribute to the ability of biopharmaceutical companies to continue to make these investments in new medicines to treat patients’ unmet medical needs,” said John Castellani, PhRMA president and CEO. “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 on the EFPIA web site, as well as the PhRMA web site.

EFPIA represents the voice of 1,900 pharmaceutical companies operating in Europe, with direct membership of 33 national associations and 40 leading pharmaceutical companies. The industry invests $30 billion in R&D per year in Europe and directly employs 700,000, including 116,000 in R&D units in Europe. PhRMA represents biopharmaceutical research and biotech companies. Since 2000, PhRMA member companies have invested approximately $550 billion in the search for new treatments and cures, including an estimated $48.5 billion in 2012.

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