EMA UNVEILS CLINICAL TRIAL DATA REFORM PLANS
December 1st, 2012
BY KEITH NUTHALL
THE EUROPEAN Medicines Agency (EMA) has unveiled plans of how it will introduce a new proactive system of releasing and controlling clinical trial data within the European Union (EU). Speaking at an EMA workshop, the agency's senior medical officer Hans-Georg Eichler said active consultations with the pharmaceutical and health sectors would begin early next year. These discussions would focus on protecting patient confidentiality; clinical-trial-data formats; rules of engagement; good analysis practice; and legal aspects of the issue. These ...
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