EMA Rejects 76% Of Requests To Label Info In Clinical Reports As Commercially Confidential
Most of the proposals by companies to redact commercially confidential information in their clinical study reports under the European Medicines Agency’s policy on proactive publication of clinical trial data have been rejected. Meanwhile, the agency is planning to make improvements to the policy this year.
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The EMA is halting its cherished transparency initiative on study data as it reckons with the fact that many of its employees will not be relocating to its new headquarters in Amsterdam. International collaboration, guidelines development and revision, and the agency's involvement in stakeholder meetings will all be cut back.
The European Medicines Agency has published more than 3,000 clinical documents on 50 individual medicines since its policy on the proactive publication of clinical data came into effect in October 2016. It says it has had “positive feedback” from those who have accessed data under the policy.