EMA consults on policy for the publication and access to clinical-trial data; slammed by industry

The European Medicines Agency has released a draft policy on the publication and access to clinical-trial data for a three-month public consultation. The Agency has committed to the proactive publication of data from clinical trials submitted in support of a marketing-authorization application, once the decision-making process has ended. The EMA says it has embarked on this process because it believes that the release of data is about establishing trust and confidence in the system.

The EMA has taken a considered approach to developing a draft policy which is based on respecting the views and concerns brought forward by a broad range of stakeholders and European bodies. The draft policy has been designed to balance out the commitment to give widest possible access to data for independent scrutiny with the need to protect personal data as well as legitimate commercially confidential information.

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