Roche increases data access
pharmafile | February 27, 2013 | News story | Research and Development, Sales and Marketing | ABPI, BMJ, Goldacre, Roche
Roche has launched a new process designed to enable greater access to its clinical trial data for researchers from outside the company.
Under the company’s scheme, announced today, an independent body will grant access to patient-level data for scientific review.
The move follows last night’s PharmaTimes head-to-head debate at the Royal Institution in London between pharma critic Ben Goldacre and ABPI chief executive Stephen Whitehead.
Fiona Godlee, editor of the BMJ, had spoken then about the publication’s campaign to force Roche to publish data on its antiviral Tamiflu.
Susie Hackett, a spokesperson for Roche UK, responded from the floor of the debate to Godlee, saying Roche was about to announce this new process for granting access to clinical trial data for third party researchers.
“Roche is listening and recognising calls for our industry to be more transparent,” she said. “We could have been more active and engaged in the debate. We know there is ongoing interest and discussion about Tamiflu.”
GSK has already announced a similar move, using an independent board to grant access to researchers, a move aimed at preventing any potential misuse and abuse of ‘raw data’ from clinical trials.
Roche’s plan is to work with what it calls an ‘independent body of recognised experts’ to evaluate and approve requests to access anonymised data.
The company insists 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.
“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.
“At the same time, we firmly believe that health authorities need to remain the gatekeeper for drug assessment and approval,” he went on.
Roche’s scheme will provide a way in which patient data can be provided to outside researchers “in a legitimate environment that ensures patient confidentiality”.
In a phrase that many pharma executives would recognise and applaud, O’Day said this method would also avoid the risk “of publishing misleading results or giving rise to public health scares and consequences”.
Last November Roche said it would let researchers have more access to data on Tamiflu.
As Godlee outlined last night, the Basel-based firm has been the subject of calls for some time from the British Medical Journal and the Cochrane Collaboration to release more data on the drug.
Adam Hill
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