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.
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.
As multiplicity issues are an important factor in every marketing authorisation application, the EMA believes that its proposed new guideline...
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