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Sea change at EMA: agency wants routine upfront submission of raw clinical trial data

This article was originally published in SRA

Executive Summary

The European Medicines Agency is changing its policy on requesting raw clinical trial data from pharmaceutical companies1,2 in an effort to address what it says are long-standing concerns around the robustness of trial analyses performed by companies. In a few years' time, the EMA hopes to be in the position of being able to require the submission of raw data with full level of details in an analysable format at the time of marketing authorisation application so that it may itself reanalyse the data independently.

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