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Leo Pharma plans to share trial data from 2014

"It is the right thing to do" says UK managing director
Leo Pharma

Leo Pharma has taken a leading approach in the trial transparency debate by pledging to open the past 23 years of drug data by 2017.

The dermatology specialist announced it would make clinical study reports as far back as 1990 available from January 1, 2014, starting with the most recent and with all available within the next three years.

Summary results will also be posted on Leo's corporate website and available to the public.

In addition to this, Leo said it intends to set up a review board comprised of independent researchers and representatives from patient associations to assess requests for anonymised patient-level data from company-sponsored trials.

Requests will be accepted from researchers, healthcare professionals and patients associations for Leo's trials back to 2000. The board will meet four times each year to review these requests.

The detailed plan makes Leo one of the first companies to commit to a specific timeline and process for sharing trial data as pressure grows on the industry to open up their drug studies to independent researchers.

This puts the company ahead of the likes of Boehringer Ingelheim, which has committed to sharing trial data, but has so far failed to detail its intentions, and Roche, which has agreed to share data for its controversial Tamiflu drug with the Cochrane Collaboration, but has been reluctant to provide wider access.

Of the other pharma companies to pledge a commitment, GlaxoSmithKline (GSK) is the only other firm to provide specific details on data sharing plans, which include the launch of an online system for researchers to request data from the company's clinical trials.

Speaking to PMLiVE, Geraldine Murphy, Leo's managing director for the UK and Ireland, said that sharing trial was “the right thing to do” considering the benefits independent evaluation of data could bring to the understanding of dermatology and thrombosis.

“By saying this we want to be a leader in the area,” she said. “If we're say we are patient centric, then we should live up to what we say.”

Commenting on the detailed plan announced by Leo, Murphy said: “We wanted to make sure we were not just talking the talk but walking the walk. We wanted to remove any ambiguities about what it is exactly we intend to.”

“We thought a lot about what people will see when they go onto Leo's website in January and had a lot of discussions. It was very important to go out with a clear message.”

More companies operating in Europe are likely to follow the path of Leo and GSK following the closure of the European Medicines Agency's (EMA) consultation on trial data legislation, which is set to feature policies to improve transparency from 2014.

However, according to Murphy, the implementation of these proposed policies was not a factor in Leo's plans.

“This was something Leo was planning to do in any case,” she said. “It was an important thing to do from a patient perspective. What we are doing is going well beyond the EMA's proposals.”

Despite the commitment, Leo did not follow GSK by signing up the AllTrials campaign, which is pressuring the industry to improve its transparency policies.

“It's certainly not something we would rule out,” said Murphy. “This is the first step though, and that commitment is the most important thing.”

Nevertheless, AllTrials co-founder and leading transparency campaigner Dr Ben Goldacre said Leo's plan was “excellent news”.

“Their commitments, and the commitments from a growing number of other companies, stand in sharp contrast to the obfuscating pharmaceutical industry trade bodies who seem to want to keep secrecy as the norm,” he said.

Article by
Thomas Meek

25th October 2013

From: Research, Regulatory



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