EMA Can Do More With Its Guidance On Multiplicity Issues In Clinical Trials, Says EFPIA

20 Jul 2017

EU research-based industry association EFPIA has made several suggestions to improve the European Medicines Agency’s draft guideline on addressing multiplicity issues in clinical trials. Multiplicity can have a substantial influence on the rate of false-positive conclusions, which may affect approval and labeling of an investigational drug.

The European Medicines Agency’s draft guideline on how companies should deal with multiplicity issues in clinical trials to control the rate of false-positive conclusions covers the relevant key principles, but does not provide enough examples of methods that can be used to control multiplicity, said the European Federation of Pharmaceutical Industries and Associations.

The draft guideline, which is intended to provide guidance on how to deal with multiple comparison and control of type...