Under-fire Roche has unveiled plans to expand access to its clinical trial data to third-party researchers but its plans have been slated by campaigners who are demanding more transparency within the industry.
The Swiss major has come in for especially fierce criticism from the AllTrials campaign set up by Sense about Science, the British Medical Journal and Bad Pharma author Ben Goldacre, over restricted access to the data on its drugs, particularly the flu treatment Tamiflu (oseltamivir). The company now says it will work with “an independent body of recognised experts to evaluate and approve requests to access anonymised patient-level data”.
Roche goes on to say it will support the release of full clinical study reports (CSRs) for all its licensed medicines via regulatory authorities and make available any CSRs that cannot be provided by these authorities upon a researcher’s request. Daniel O’Day, chief operating officer of Roche Pharma, said “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”.
‘Gatekeeper for drug assessment’
However, he added that “at the same time, we firmly believe that health authorities need to remain the gatekeeper for drug assessment and approval”. Mr O’Day said “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”.
Roche added that it “acknowledges the specific public interest in data transparency” concerning Tamiflu, saying that health authorities worldwide “have received all the information they have requested”. The firm added that of 74 completed Roche-sponsored Tamiflu trials, 71 are in the public domain, while “arrangements are underway for the three sponsored trials which are completed but not yet in the public domain to be posted”.
It is setting up a “MUlti-party Group for Advice on Science” headed by four renowned scientists in the field of influenza “to look at data on Tamiflu, identify any unanswered questions and agree on a statistical analysis plan”. They will invite independent experts and third parties to their meeting, which is scheduled to take place in June.
The response from Roche’s critics has been swift and not enthusiastic. Sense About Science director Tracey Brown said to the BBC: “Does Roche expect applause for announcing that it will continue to keep clinical trial findings hidden? They’re on another planet. Roche’s response is pathetic. Which bit of All and Trials do they not understand?”
Carl Heneghan, director of the Centre of Evidence-Based Medicine at the University of Oxford, was quoted by the BBC as saying “how can any panel be independent if they appoint it and oversee it? It also means there will be confidentiality clauses within any agreement. Either you provide the data in a transparent manner or you don’t”.
