Roche Provides More Access to Clinical Trial Data

Roche Provides More Access to Clinical Trial Data

February 27th, 2013 // 2:52 pm @ jmpickett

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In response to enormous criticism over its handling of Tamiflu clinical trial data, Roche announced a new plan to increase access to such information and its approach mimics steps begun recently by GlaxoSmithKline. Specifically, Roche will work with an “independent” group of “recognized experts” to evaluate and approve requests to access patient-level data and will also support the release of case study reports for all of its licensed medicines.

The move comes after Roche found itself in a heated row with researchers at the Cochrane Collaboration, who two years ago complained they were repeatedly stymied in their efforts to fully assess up-to-date efficacy information for the influenza treatment. More recent attempts to obtain data prompted a response from the drugmaker that critics called stonewalling. Roche then responded with a compromise offer to form a multi-party advisory board for determining which data should be accessed, but that went nowhere (back story).

“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,” Daniel O’Day, the chief operating officer at Roche Pharma, says in a statement. “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.”

The change of heart reflects ongoing controversy over disclosure of clinical trial data. Over the past few years, there have been scandals in which important data about various drugs was not known yet safety and efficacy issues swirled around the medications. These included the Avandia diabetes pill sold by Glaxo (GSK), which last fall, agreed to make available patient-level data to independent researchers, a step that came after the drugmaker paid a $3 billion settlement to settle civil and criminal charges that included a failure to release trial data (see this).

Earlier this month, the lead legislator for the Environment, Public Health and Food Safety Committee in the European Parliament announced plans to toughen proposed legislation that is designed to bolster clinical trial practices and activities on the continent (read here). Meanwhile, BMJ will no longer publish studies unless patient level data is made available. BMJ is also one of several organizations sponsoring an online petition calling for drugmakers to make public all trial data (look here).

So what exactly is Roche willing to do? The drugmaker says that an independent body assess the validity of requests for data, which will be available in a “secured system.” From there, access to patient data will be available for trials that have been submitted with a regulatory application and will be available after regulatory reviews have been completed in the US and European Union. This process begins this year and Roche says talks are being held with other drugmakers “to see if this can be an industry-wide initiative.”

Whether other drugmakers will, in fact, accede is unclear. In recent weeks, both the Pharmaceutical Research & Manufacturers of America and the Association of British Pharmaceutical Industry have released separate statements that derided the notion of releasing patient-level data and case study reports. PhRMA, in particular, was adamant that this would compromise innovation (read here).

Roche did issue some caveats, though. For instance, the drugmaker will release full case study reports, summaries and safety updates for medicines approved by the European Medicines Agency. But the information will be edited “in line with relevant country or regional laws” in order to ensure patient confidentiality and “to protect legitimate commercial interests, including intellectual property rights.” But the drugmaker “will provide any CSR on request that cannot be obtained from the EMA for third-party researchers” beginning this April. “This will enable access to all Roche CSRs for researchers,” the drugmaker maintains.

As for Tamiflu data, Roche says that 71 of 74 completed trials are in the public domain either as a primary publication or secondary publication or on rochetrials.com, and arrangements are being made for the remaining three trials to be posted. So Roche is forming what it calls a Multi-party Group for Advice on Science, which will consist of four “renowned” scientists in the field of influenza to review Tamiflu data, “identify any unanswered questions and agree on a statistical analysis plan.”

From there, Roche says there will be an agreement, but does not offer specifics concerning parties or substance, but the drugmaker goes on to maintain it will provide access to all requested Tamiflu clinical trial data for the analyses. The scientists – Albert Osterhaus of Erasmus Medical Centre in Rotterdam, Menno De Jong of the Academic Medical Centre in Amsterdam, Arnold Monto of the University of Michigan and Richard Whitley of the University of Alabama – will invite independent experts and third parties to a meeting in June.

[UPDATE: We should note that not all of these scientists are independent. As recently as last fall, for instance, Osterhaus, Monto and Whitley were listed as scientific advisors or consultants to Roche, and Osterhaus has also been a grant recipient (read this).]

And so, there may be issues with this approach. After all, if Roche wants the Tamiflu exercise to be taken seriously, the drugmaker should gather scientists without any ties. This is likely to cause skepticism about the commitment to forming an independent panel for the overall purpose of releasing patient-level data and case study reports.

Morever, the approach has, so far, not been tested. As a result it remains to be seen how requests for data are handled. Glaxo, meanwhile, has not yet released the names of its own independent panel of experts or specified a launch date. But as we opined last summer, “the pharmaceutical industry would do itself a favor by recognizing that such steps – even if imperfect – are long overdue. For an industry that beats a loud drum about wanting to heal patients, the missteps over clinical trial data have done nothing but leave the public with a jaundiced view of its real mission.”

We asked Thomas Jefferson of the Cochrane Collaboration and PhRMA for comment, and will update you accordingly.