Sanofi to expand access to clinical trial data

Published: 8-Jan-2014

In support of PhRMA and EFPIA principles on responsible sharing of data

From this month, Sanofi will expand access to information and data from the group's clinical trials, in support of the joint Pharmaceutical Research and Manufacturers of America (PhRMA) and European Federation of Pharmaceutical Industries and Associations (EFPIA) Principles for Responsible Sharing of Clinical Trial Data, which came into effect on 1 January 2014.

Christopher Viehbacher, Sanofi's Chief Executive, is the current President of the EFPIA.

Viehbacher said Sanofi has a 'history of contributing in this collective effort of sharing clinical trial data and results with researchers and patients' through initiatives such as Project Data Sphere, an independent initiative of the Life Sciences Consortium of the CEO Roundtable on Cancer, the Coalition Against Major Diseases, and Prize4Life.

'Finding new therapies can be accelerated by fully sharing the successful and unsuccessful research results with other researchers,' Viehbacher commented.

'Data sharing helps to reduce duplication and allows researchers to build more effectively on the findings of other researchers. The private sector has taken a lead on this which I would hope academic researchers will follow.'

Data sharing helps to reduce duplication and allows researchers to build more effectively on the findings of other researchers

Under its new commitments, Sanofi will provide access to clinical trial data and related documents, including Clinical Study Reports (CSR), for studies sponsored by group companies that conduct clinical studies in humans.

These studies must have been submitted to regulatory agencies in the US and EU and the product approved by both agencies on or after 1 January 2014.

Sanofi will continue to submit for publication the results from all group clinical studies, regardless of the study outcome.

In addition, the company is working with regulators and industry partners to adopt mechanisms that will enable clinical study sponsors to provide lay language summary results directly to the individuals who participate in trials.

To enable the process for requesting and gaining access to clinical trial data, Sanofi is participating in a multi-company portal for clinical trial data sharing at and a link to this portal is now available on the Sanofi website.

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