Yet another large drugmaker has made a commitment to release clinical trial data. The latest to do so is Sanofi, which will join an effort begun last year by GlaxoSmithKline to establish a web site where researchers can request study information.
In announcing its decision, Sanofi also expressed support for a data sharing plan declared last summer by the pharmaceutical industry trade groups in the US and Europe, which want to offer an alternative to a more sweeping proposal being considered by the European Medicines Agency (read here and here).
“Finding new therapies can be accelerated by fully sharing the successful and unsuccessful research results with other researchers. Data sharing helps to reduce duplication and allows researchers to build more effectively on the findings of other researchers,” says Sanofi ceo Chris Viehbacher, who is also president of the European Federation of Pharmaceutical Industries and Associations, in a statement.
Whether the gesture will satisfy industry critics remains to be seen. Sanofi will make available trial data and related documents, including clinical study reports, for studies in human that were submitted to US and European regulators and the product must have been approved by both agencies - on or after January 1, 2014.
And for the Sanofi Pasteur vaccine division, the requested studies must have been submitted to either regulator and the product must have been approved on or after the same date. Although the drugmaker says it will continue to submit for publication the results from all company-sponsored clinical studies, regardless of the study outcome, trial data for older prescription drugs and vaccines will not be made available to researchers.
The move comes amid a growing clamor for wider access to detailed trial data in after years of controversy over the extent to which drugmakers disclose clinical trial data. The pharmaceutical industry has long been criticized for failing to fully make underlying patient-level data available to others who seek to verify results.
Drugmakers have long insisted data is proprietary, but critics say the reluctance to disclose such information can be a red herring for hiding unflattering results that may limit sales. They also argue that, without access to this underlying information, it can be difficult, if not impossible, for researchers to verify the safety and effectiveness of prescription drugs.
The debate has factored into numerous scandals in which drugmakers have been accused of withholding important information about side effects. Glaxo, in particular, was cited for such behavior with its Avandia drug, which figured prominently in a $3 billion settlement the drugmaker recently reached with the US Department of Justice for a number of infractions.
Last year, Glaxo became the first drugmaker to respond to the controversy by vowing to make data available and, more recently, involve its rivals. The effort reflects a deepening realization in the pharmaceutical industry that battling regulators and researchers over access is likely to further erode trust and could result in still more regulation.
At the same time, though, the EFPIA and PhRMA, the US trade group, have harshly criticized the EMA proposal to proactively make trial data available to researchers once an approval decision has been made. Their protests have had some impact. The EMA recently delayed plans to finalize its proposal.
For the most part, drugmakers have resisted any change, although since Glaxo launched its web site to provide patient-level data to researchers, upon request, several others have now agreed to participate, including Roche, Boerhinger Ingelheim, ViiV Healthcare – a joint venture between Glaxo, Pfizer and Shionogi to develop HIV medicines.
And last month, a deal was reached at the European Parliament that would require drugmakers and academic researchers to upload all results of their European clinical trials to a publicly accessible database (see this).
Just the same, industry efforts have so far yielded mixed reactions.
Pfizer last month expanded a policy and created a web site that will publish synopses of clinical study reports filed with regulatory agencies for approved products for which basic results are posted in the ClinicalTrials.gov registry, but only dating to September 2007. These CSR synopses will include summary results for all primary and secondary endpoints, but any data that could be used to identify individual patients will be removed (more here).
This qualification is one of two central sticking points that have defined the tussle over data. Drugmakers argue that patient level data should not be disclosed in such a way that patient privacy can be compromised. But some critics argue certain material can and should be released in order to detect safety signals and can be accomplished without breaching privacy.
The other area of debate surrounds what drugmakers call confidential commercial information. The industry argues they may suffer harm if rivals obtain certain data and are able to deduce insights into drug development or strategic thinking. AbbVie and InterMune cited this concern when they went to court to block the EMA from releasing trial data.
Meanwhile, Glaxo is haggling with a group of researchers who want clinical study reports for an infamous study of its Paxil antidepressant. They maintain Glaxo has balked at the request and has raised doubts about its commitment to releasing data. In the process, the dispute has raised questions about whether Glaxo complied with a 2004 consent order with the New York State Attorney General to publicly disclose the Paxil trial data.
Another issue is independence. Both Glaxo and Pfizer maintain the panels formed to vet researcher requests are independent and, essentially, will function like Data Safety Monitoring Boards that review trial data for safety and effectiveness signals. However, the drugmakers are deciding on the composition of their panels, both of which contain people who have worked as consultants.
