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Boehringer: Move towards trial transparency is "irreversible"

Pharma company plans to publish all scientific data

Move towards trial transparency is “irreversible” says Boehringer chair

Boehringer Ingelheim has become the latest company to say it will publish all scientific data from its clinical trials as the industry continues to feel pressure from open data campaigners.

Speaking at the Germany-based pharma company's annual conference, Boehringer's chair of the board of managing directors Professor Andreas Barner said the move towards transparency was “irreversible”, although there must be a standard format for trial publication that all companies follow.

“As a company that intensively and successfully conducts research, we will further intensify this exchange in the spirit of greater transparency by publishing all scientific data from all clinical studies for which the company is responsible,” said Prof Barner.

“In addition, we will in future make available to interested scientists all study data – up to the level of anonymised patient data – after the completion of the registration process and also when we have halted development.”

It was a bold move for the company, although it stopped short of joining GlaxoSmithKline in signing up to All Trials, a campaign group for open data that counts IQWIG and NICE among its supporters.

Nevertheless, Prof Barner said that transparency and availability of data was the “right direction” for the industry.

Questions remain on how the company will implement this promise, although Barner said that there should be a standard format for all companies to release data so that nobody is at a disadvantage.

Transparency has been a hot topic for pharma in recent months, stemming primarily from the Cochrane Collaboration's battle with Roche to release all data for flu drug Tamiflu after questions were raised about the medicine's efficacy.

Cochrane gained something of a victory earlier this month when Roche announced it would release data from all 74 Roche-sponsored trials involving Tamiflu to Cochrane over a period of several months.

However, the move was only given a cautious welcome from Cochrane, which raised concerns about the company's intention to edit the data to “ensure patient confidentiality and to protect legitimate commercial interests”.

Roche also faced criticism from AllTrials member group Sense About Science about the “years of persistence and publicity” that was needed to obtain the data.

26th April 2013

From: Research, Regulatory



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