EU, US trade bodies outline drugmakers' clinical data sharing pledges

The European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Pharmaceutical Research and Manufacturers of America (PhRMA) detailed commitments Wednesday under which drugmakers will "dramatically increase the amount of information available to researchers, patients and members of the public." Robert Hugin, chairman of PhRMA and CEO of Celgene, remarked that "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."

Under the plans, patient-level and study-level clinical trial data, full clinical study reports, and protocols from clinical trials for approved drugs in the US and Europe will be made available to "qualified scientific and medical researchers upon request and subject to terms necessary to protect…confidential commercial information." The trade bodies noted that member companies will also "work with regulators to provide a factual summary of clinical trial results to patients who participate in clinical trials." In addition, drugmakers will at a minimum publish data from all Phase III studies regardless of their outcome.

"The data sharing commitments reflect EFPIA member companies' strong support for sharing clinical trial data to benefit patients and foster scientific discovery," commented the association's director general Richard Bergström. The commitments are expected to be implemented starting next year.

Last month, the European Medicines Agency released draft guidance on the publication and access to clinical trial results, with a finalised policy due by the end of the year. At the time, Sanofi CEO Chris Viehbacher, who is also president of EFPIA, suggested the proposal could undermine the competitiveness of the industry because confidential information could be accessed by competitors. The EMA's plan was also criticised by the PhRMA.

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