Roche announced they will set up an 'independent body of recognized experts' to evaluate and approve requests to access patient-level clinical trial data by third party researchers.
Roche will support the release of case study reports for all its licensed medicines. The Swiss manufacturer follows a similar commitment made by the English GlaxoSmithKline who backed the All Trials campaign earlier this month.
“We understand and support calls for our industry to be more transparent about clinical trial data with the aim of meeting the best interests of patients and medicine,” said Daniel O’Day, Chief Operating Officer of Roche Pharma in a statement released yesterday. “At the same time, we firmly believe that health authorities need to remain the gatekeeper for drug assessment and approval. We believe we have found a way in which patient data can be provided to third party researchers in a legitimate environment that ensures patient confidentiality and avoids the risk of publishing misleading results or giving rise to public health scares and consequences.”
An ‘independent’ body will assess requests for patient-level data on drugs that have completed the regulatory review process in the US and the EU, which may be released upon agreement starting this year. Roche invited other pharma players to consider whether this could be an industry-wide initiative.
However it is also worth noting that the four-man ‘independent’ body includes three consultants who have all received consulting fees from Roche in the past. Pharmalot originally uncovered this development, stating that Albert Osterhaus, Arnold Monto and Richard Whitley have all worked with the company previously (source), raising the question of whether this panel is truly independent and leading some to ask whether this is a victory for clinical trial transparency at all.
The company declared support for release of summary reports and safety updates on medicines approved by the EMA, pointing out that the information will be ‘edited in line with relevant country or regional laws’ in an effort to ‘protect commercial interests and intellectual property rights.’ CSRs that cannot be obtained through the EMA will be available to independent researchers upon request.
Roche will continue to provide all information requests by health authorities for approval purposes, and will publish summary results at rochetrials.com and clinicaltrials.gov, as well as EudraCT, a database of trials conducted across the EU, once the platform is operational.
They also declared support for the European Medicines Agency’s (EMA) commitment to publication of clinical trial data, and they remain a member of an advisory group developing the EMA access guidelines, scheduled for release in 2014.
The move comes after Roche became a subject of a government enquiry into stockpiling oseltamivir (Tamiflu) after the Cochrane Collaboration have claimed that the manufacturer withheld results of 60% of the Tamiflu trials, making it impossible for the regulators to adequately assess the safety and efficacy of the drug. As a result some MPs said that the £500 million the NHS spent on the drug in 2009 should be returned. The Cochrane Collaboration and the British Medical Journal launched in 2009 a campaign to access data from all the trials for independent assessment, and despite a promise made by the company in December that year to make 'full study reports' available, none of them have been released to date.
“Health authorities worldwide have received all the information they have requested regarding Tamiflu,” read a statement released by Roche yesterday, adding that 96% of all relevant trials are not in the public domain, and that arrangements are being made for the remaining three trials to be published. Additionally, the manufacturer made a commitment to set up an advisory group that will 'identify any unanswered questions and agree on a statistical analysis plan'. Following an undefined agreement, the company pledges they will provide access to all requested clinical trial data.
Despite the seemingly positive announcement, the close proximity of the ‘independent’ body to Roche is bound to leave a bitter taste in campaigner’s mouths. It will be interesting to see how this story develops…
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