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UCB joins clinical trial data sharing portal

Follows GSK, Lilly, Roche and others in committing to transparency website


UCB has become the latest in a line of pharma firms to sign up to a website which allows researchers to access some of the data from manufacturers' clinical trials.

Bayer, Boehringer Ingelheim, GSK, Lilly, Novartis, Roche, Sanofi, Takeda and ViiV Healthcare have already signed up to but UCB says it is the “first midcap biopharma company” to do so.

“Because we believe that this will lead to better solutions for patients, we have committed to sharing data from our clinical studies in a responsible way,” said UCB chief medical officer Iris Loew-Friedrich. “We hope this will enhance disease understanding, generate new insights and help develop new treatments.”

The site allows researchers to request access to anonymised patient level data and supporting documents from clinical studies - but their proposals are reviewed by an independent panel which decides whether permission should be granted.

Transparency has been a vexed issue for pharma over the last few years, with the European Medicines Agency's much-anticipated policy - due to have been published last month - not now ready for enactment until October.

The regulator says the delay has been caused by a need for “further clarifications on wording and practical arrangements”, but the agency has been accused by proponents of clinical trial transparency of watering down its 2013 draft proposal following pressure from the pharma industry.

Meanwhile, the European Parliament voted in April in favour of legislative proposals to make clinical trial data public.

UCB says its policy on data sharing “embraces” the Principles for Responsible Clinical Trial Data Sharing released by the US and European pharma trade associations PhRMA and EFPIA.

It adds: “UCB will accept requests relating to all clinical studies that were considered 'pivotal studies' for purposes of regulatory approval of the core UCB medicines.”

Requests for access to additional clinical study data will be considered on a case-by-case basis, the company concludes in a statement.

Article by
Adam Hill

5th August 2014

From: Research



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