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Regulatory Focus™ > News Articles > Regulatory Update

Regulatory Update

Posted 01 July 2009

To avoid delays in drug approval due to questions of bias in clinical trials, before studies begin sponsors should identify methods to account for planning, conducting or analyzing results of a confirmatory study, according to a new European Medicines Agency draft guideline. Interpreting the results of a trial is always problematic when the number of missing values is substantial. The new guideline provides advice on how to address the presence of missing data in a regulatory submission during a clinical trial. According to the guidance:

 

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