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Regulatory Update

Posted 01 July 2009 | By

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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