Sanofi has set out its procedures for expanding access to information and data from the group’s clinical trials, in line with the joint EFPIA-PhRMA Principles for Responsible Clinical Trial Data Sharing that took effect on 1 January 2014.
Christopher Viehbacher, chief executive officer of Sanofi, is the current president of EFPIA, the European Federation of Pharmaceutical Industries and Associations.
The joint Principles with Pharmaceutical Research and Manufacturers of America (PhRMA) provide a framework for researchers to access patient-level data, clinical-trial protocols and clinical-study reports for new medicines approved in the US and the European Union after 1 January 2014.
Collective effort
As Viehbacher pointed out, 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, a collaborative programme aimed at creating a common platform for historical trial data to optimise cancer-research efforts.
The initiative involves the Life Sciences Consortium of the US-based CEO Roundtable on Cancer, as well as 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.”
Access conditions
Under its new commitments, Sanofi will provide access to clinical-trial data and related documents, including Clinical Study Reports, for studies sponsored by group companies conducting clinical trials in humans.
These studies must have been submitted to regulatory agencies in the US and the EU, and the associated product approved by both agencies on or after 1 January 2014.
In the case of vaccine trials conducted by Sanofi Pasteur, requested studies must have been submitted either to the US or the EU regulatory agencies and the product approved by either agency on or after 1 January 2014.
For all trials conducted by the Sanofi group, the requested trials must first have been accepted for publication.
Summary results
Sanofi is working with industry partners and regulators towards mechanisms that will enable clinical-study sponsors to provide lay-language summary results directly to the individuals who participate in trials, the group noted.
One component of the Sanofi initiative is the group’s participation in the online portal launched by enterprise-software specialist ideaPoint to make anonymised patient-level data from clinical trials available to researchers on request (see separate story on this page).
So far, Boehringer Ingelheim, GlaxoSmithKline and ViiV Healthcare have also signed up to list trials on the ideaPoint site. A link to the portal was available on the Sanofi.com website as of 1 January.
Independent Review Panel
Requests for Sanofi trial data will be assessed by an Independent Review Panel comprising “publicly named scientists and healthcare professionals who are not employees of the company”, the group explained. The membership of this panel will be made public.
Decisions on granting access will be based on “criteria which are aimed at ensuring that the proposal has scientific merit – that is, it has the potential to advance medical knowledge and contribute to the advancement of public health”, Sanofi emphasised.
Moreover, the proposed research must be feasible and the research team suitably qualified to conduct it.
Sanofi will not share data with third parties where the informed consent obtained for a particular trial does not allow for this. Any use of trial data by a third party must “address a scientific question in the same disease as the original trial, unless the informed consent expressly allows broader use”.
All data shared with third party researchers will be anonymised “according to applicable standards”, Sanofi added.
It will not share anonymised data where “we believe that there is a reasonable likelihood that the individual could be re-identified, for example, for certain rare diseases”.
