EMA Can Do More With Its Guidance On Multiplicity Issues In Clinical Trials, Says EFPIA
Executive Summary
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.
You may also be interested in...
ICH Consults On Harmonized Standards For Choosing Estimands In Clinical Trials
An addendum to the International Council for Harmonisation's guideline on statistical principles for clinical trials proposes a new framework on how the concept of estimands can be used to help clearly describe the effects of a medicine.
Multiple Endpoints In Clinical Trials: US FDA Advises How To Avoid False Positives
Draft guidance suggests ways to control for erroneous conclusions when there are multiple analyses of a drug’s effects.
EMA planning new guidance to address "multiplicity issues" in drug clinical trials
The European Medicines Agency is seeking feedback on its proposal to develop new guidance on multiplicity issues in drug trials1. Multiplicity issues, if not handled properly, can present an elevated probability of "false positives" when performing multiple analyses and hence result in unsubstantiated effectiveness claims for the drug.