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U.S., Europe Pharma Industries Implement Trial Data Sharing

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Pharmaceutical industry associations in the U.S. and Europe began implementing their agreement from this past summer to provide more access to data from clinical trials conducted by their member companies. One of those companies, Paris-based Sanofi, released its procedures today for accessing its clinical trial data.

The new processes are a result of a set of principles agreed upon between European Federation of Pharmaceutical Industries and Associations and Pharmaceutical Research and Manufacturers of America in July 2013, with 1 January 2014 set as the implementation date. Those principles commit the member companies to provide access to “qualified scientific and medical researchers” seeking clinical trial data, including full reports and protocols, as well as results down to the granular level of individual patients, with appropriate privacy protections.

The principles also call for pharma companies and regulators to provide summaries of clinical trial results to patients taking part in the trials, with reports of trials made public through U.S. and European regulators, upon their approval of new medications or new uses for current drugs. In addition, companies recommitted to publishing results of clinical trials, no matter the outcome of those trials, with at least all phase 3 (late-stage) trials and other clinical studies of significance submitted for publication.

Implementing the principles is largely a responsibility of the pharmaceutical companies. Sanofi released its procedures today, which include participation in a multi-company data-access portal, where researchers can submit their requests for data. Sanofi’s CEO Christopher Viehbacher is the current president of the European Federation of Pharmaceutical Industries and Associations.

Sanofi says it will provide access to clinical study reports and related data for studies sponsored by the company and on products approved by both the U.S. and European regulatory agencies on or after 1 January 2014. The company makes an exception on studies of products approved for Sanofi Pasteur, its vaccine division, where the product need be approved by one (not both) of the agencies. Sanofi says it will continue to submit the results from all sponsored clinical studies for publication, regardless of the outcome.

Other pharma companies started opening their clinical trial data independently of industry programs. GlaxoSmithKline (GSK) announced in October 2012 it would patient-level access to its clinical study data, and encourage other companies to do the same. In February 2013, Roche agreed to open its clinical trial data, partially in response to pressure from medical journals and Cochrane Collaboration for trial data on the company’s Tamiflu drug. GSK and Roche, with Sanofi, Boehringer Ingelheim, and ViiV Healthcare operate a shared portal for researchers to submit their requests for data, although each company can define its criteria for acceptance.

In addition, Institute of Medicine in the U.S., one of the National Academies, is conducting a study of clinical trial data access practices, with the goal to “develop guiding principles and a framework for the responsible sharing of clinical trial data.” The study group held a public workshop in October 2012, and expects to issue its interim report for comment later this month.

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