Roche (RHHBY) Peels Back the Curtain on Clinical Trial Data
2/27/2013 8:13:08 AM
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. “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.