Staburo commented on EMA ‘Guideline on multiplicity issues in clinical trials’

Staburo commented on EMA ‘Guideline on multiplicity issues in clinical trials’

EMA_guideline_input_Staburo

Staburo submitted comments on EMA’s draft guideline on multiplicity issues in clinical trials. Multiplicity issues arise in many areas of clinical development, including biosimilars  and translational medicine. The guideline is intended to provide guidance on how to deal with multiple comparison and control of type I error in the planning and statistical analysis of clinical trials.