Roche pledges greater access to clinical trial data

Hannah Blake

pharmaphorum

Swiss pharmaceutical company Roche has announced it is expanding access to its clinical trial data for third party researchers. The company is going to work with an independent body of recognized experts to evaluate and approve requests to access anonymised patient-level data. Roche will also release the full clinical study reports for all its licensed medicines via regulatory authorities.

“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. 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.”

Daniel O’Day, Chief Operating Officer of Roche Pharma.

There are still ongoing discussions around the withholding of clinical trial data for Roche’s antiviral treatment, tamiflu. Roche has stated it “acknowledges the specific public interest in data transparency concerning the antiviral Tamiflu” and that “health authorities worldwide have received all the information they have requested regarding Tamiflu”. According to the pharma company, of the 74 clinical trials of tamiflu sponsored by Roche, 71 are in the public domain. Arrangements are underway for the final three trials which are completed but not yet in the public domain to be posted.

Roche has also stated that it supports the European Medicines Agency (EMA) in its commitment to the proactive publication of data from all clinical trials supporting the authorisation of medicines. Roche is a member of one of the EMA advisory groups working on the new EMA data access guidelines. The policy is scheduled to come into force early 2014.

Roche’s move for greater transparency comes three weeks after its rival, GlaxoSmithKline vowed to publish all of its clinical trial data publicly by signing the AllTrials campaign led by the BMJ and Ben Goldacre.