Endpoint Adjudication Methods used in Clinical Trials for 69% of the NMEs approved by FDA and 41% by EMA

Beat Widler with Ken Getz from Tufts University and colleagues from our partners published a research article on DIA’s Therapeutic Innovation & Regulatory Science, Journal

The objective of that paper was to analyze how often adjudicated methods across efficacy and safety assessments were used in drug approvals in the European Union and United States in 2013 and early 2014. Methods: A total of 35 new molecular entities (NMEs) approved by the US Food and Drug Administration (FDA) and 88 European Medicines Agency (EMA) approvals in Europe were included in this analysis.

A goal of this publication was to contribute to more robust processes and approaches in the adjudication of endpoints which should allow better protection of patients’ safety and data integrity.

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