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October 28, 2016

Europe's Clinical Trial Data Open Access Will Affect U.S.

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Bloomberg BNA Biotech Wach - Europe's new clinical trial data open access policy will directly impact U.S. clinical trials, an attorney told Bloomberg BNA Oct. 27.

The European Medicines Agency (EMA) announced Oct. 20 it is giving open access to clinical reports for new medicines for human use authorized in the European Union (EU).

Mark Barnes of Ropes & Gray, Boston, told Bloomberg BNA in an e-mail: “The entire pharma industry has been waiting for the release of these guidelines on clinical study report transparency. This will affect trials around the world, including all parts of the U.S., whose results will be used to support marketing applications to the EMA.”

Barnes added, “Huge issues remain with how personal privacy of trial subjects will be protected as these big data come on line and how commercial confidentiality can also be preserved, When vital commercial interests are at stake. EMA still has far to go in the ethics and logistics of how this will be implemented.”

Documents Published on Website

The publication of the clinical reports follows the adoption by EMA of a policy on the publication of clinical data for human medicines . The data, which will be available on a website, will include the clinical reports contained in all initial marketing-authorization applications submitted to the EMA on or after the policy's entry into force on Jan. 1, 2015.

The policy also applies to applications submitted on or after July 1, 2015, to vary a marketing authorization for an extension, modification of indication or line extension.

The documents will be published once the European Commission decides whether or not to grant a marketing authorization and also when applications are withdrawn before the EMA issues an opinion.

EMA to Biopharmas: Don't Be Afraid

In a press briefing on Oct. 20, the EMA's Executive Director Guido Rasi said the agency is the first regulatory authority worldwide to provide access to researchers, patients and health-care professionals “to look at or even download clinical trial data.”

He said that he understood drug companies might be apprehensive about people misusing their data but urged them: “Don't be afraid.”

Rasi said, “Companies shouldn't be afraid of transparency because shared knowledge about medicines and underlying clinical studies will lead to more efficient medical development because it will eliminate duplication and help generate new ideas.”

He said the policy and the website are a significant step forward to transparency to help build trust. “That trust in our work is essential if we want medicine to be prescribed comfortably and safely and in a most effective manner. This step will also advance our global debate about transparency and will facilitate scientific reanalysis, increase scientific knowledge and further inform our decision making in the future.”

Data on Two Medicines Released

Once the process is fully implemented and the backlog has been dealt with, the EMA said it plans to publish the reports 60 days after it issues a decision on an application or within 150 days after the receipt of the withdrawal letter.

As a first step, the EMA published on Oct. 20 data for two medicines: Kyprolis (carfilzomib), an orphan cancer medicine marketed by Amgen Inc. for the treatment of multiple myeloma, and AstraZeneca subsidiary Ironwood Pharmaceuticals’ gout medicine Zurampic (lesinurad). The data represent approximately 260,000 pages of information for over 100 clinical reports. Data will be progressively added online for all applications concerned since the policy entered into force.

“This will be a learning curve for the agency and all its stakeholders, as they start to apply the policy for the first time. While the policy gives an unprecedented proactive access to clinical data, it also demands the highest standard of protection of patients’ personal data. The process will evolve over time as more experience is gained and may lead to adaptations of EMA's guidance,” the agency said.