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Roche releases all Tamiflu trial data to Cochrane

Redacted trial reports released after three years of campaigning

Roche releases all Tamiflu trial data to Cochrane

In a coup for open trial data campaigners, Roche has agreed to release all of the trial data for its controversial influenza drug Tamiflu to the Cochrane Collaboration.

Health research body Cochrane first requested access to all 74 Roche-sponsored trials involving Tamiflu in 2009 after discrepancies between different regulatory bodies' views on the drug raised questions about its effectiveness.

However, Roche only granted the group access to one part of a series of ten Tamiflu trials, telling Cochrane “you have all the detail you need to undertake a review and so we have decided not to supply any more detailed information”.

This led to a campaign from Cochrane for open access that has gained serious momentum in the past few months following the publication of Ben Goldacre's Bad Pharma and the subsequent launch of the AllTrials campaign, which has received backing from notable groups as IQWIG, NICE, and, arguably most significantly, the pharma company GlaxoSmithKline (GSK).

Roche said earlier this year it planned to allow access to clinical trial results for licensed medicines, but Tamiflu's life cycle leader Don MaClean has now emailed Cochrane saying Roche will provide the clinical study report (CSR) for each of the 74 Roche-sponsored Tamiflu trials in a staggered approach over the next few months to cater for their length (each CSR is about 2,000 to 3,000 pages long).

Cochrane said it “cautiously” welcomed the move, but raised concerns about Roche's comment it would edit the data to “ensure patient confidentiality and to protect legitimate commercial interests”, potentially making analysis and interpretation impossible.

Sile Lane, director of campaigns at AllTrials member Sense about Science, also commented on the time it took for Roche to release the data: “It shouldn't have taken the researchers years of persistence and publicity to get [access to] these Tamiflu results.

“Roche has an opportunity to tell the public and research community that it won't happen like this again,” she added.

In an email to PMLiVE, a Roche spokesperson commented: “By amending and executing the data transparency policy Roche has taken a leading role in improving access to clinical trial data for third party researchers.

“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.”

In addition to releasing the redacted Tamiflu data to Cochrane, Roche has set up the Multiparty Group for Advice on Science (MUGAS) – a group of various third parties to review the data on Tamiflu.

MUGAS is due to meet on June 18, although Cochrane is still to accept its invitation from Roche, saying it has asked for “further clarification”.

On top of this, Cochrane noted that three of four key MUGAS partners are advisors to Roche, potentially compromising the group's findings.

However, Albert Osterhaus, one of the key members of MUGAS and a Roche scientific adviser, told Cochrane it had no reason to be concerned, and that MUGAS partners "stop wasting precious energy to this pointless discussion about scientific integrity and instead engage in a constructive collaboration to address urgent health issues".

There are also wider moves towards transparency following a report last year by the European Medicines Agency (EMA) that said clinical trial data will have to be published, although the practicalities of the process are still to be developed.

5th April 2013

From: Research, Sales, Regulatory, Healthcare

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